Journal of Gerontology: MEDICAL SCIENCES 2002, Vol. 57A, No. 1, M26–M36 Copyright 2002 by The Gerontological Society of America Effects of Moderate-Intensity Exercise on Physiological, Behavioral, and Emotional Responses to Family Caregiving: A Randomized Controlled Trial Abby C. King,1,3 Kellie Baumann,2 Paula O’Sullivan,3 Sara Wilcox,4 and Cynthia Castro3 1Division of Epidemiology, Department of Health Research and Policy, 2Center for Research on Women’s Health and Reproductive Medicine, Department of Obstetrics and Gynecology, and 3Stanford Center for Research in Disease Prevention, Department of Medicine, Stanford University School of Medicine, Palo Alto, California. 4Department of Exercise Science, School of Public Health, University of South Carolina, Columbia. Background. The study objective was to determine the health and quality-of-life effects of moderate-intensity exercise among older women family caregivers. Methods. This 12-month randomized controlled trial involved a volunteer sample of 100 women aged 49 to 82 years who were sedentary, free of cardiovascular disease, and caring for a relative with dementia. Participants were randomized to 12 months of home-based, telephone-supervised, moderate-intensity exercise training or to an attention-control (nutrition education) program. Exercise consisted of four 30- to 40-minute endurance exercise sessions (brisk walking) prescribed per week at 60% to 75% of heart rate reserve based on peak treadmill exercise heart rate. Main outcomes were stress-induced cardiovascular reactivity levels, rated sleep quality, and reported psychological distress. Results. Compared with nutrition participants (NU), exercise participants (EX) showed significant improvements in the following: total energy expenditure (baseline and post-test means [SD] for EX 1.4 [1.9] and 2.2 [2.2] kcal/kg/day; for NU 1.2 [1.7] and 1.2 [1.6] kcal/kg/day; p .02); stress-induced blood pressure reactivity (baseline and post-test systolic blood pressure reactivity values for EX 21.6 [12.3] and 12.4 [11.2] mm Hg; for NU 17.9 [10.2] and 17.7 [13.8] mm Hg; p .024); and sleep quality ( p .05). NU showed significant improvements in percentages of total calories from fats and saturated fats relative to EX ( p values .01). Both groups reported improvements in psychological distress. Conclusions. Family caregivers can benefit from initiating a regular moderate-intensity exercise program in terms of reductions in stress-induced cardiovascular reactivity and improvements in rated sleep quality. D URING the upcoming decades, the burden and cost of providing care to an ill or disabled relative will touch nearly every U.S. household (1). The potentially devastating physical and emotional impact of caregiving was recently underscored by the Caregiver Health Effects Study, in which family caregiving accompanied by emotional strain was an independent risk factor for mortality among older adults (2). Data from this study and others have shown that caregivers are less likely than same-aged peers to engage in preventive health behaviors that are important for chronic disease prevention and control, including regular physical activity (3–7). Regular physical activity of even moderate intensity decreases cardiovascular disease risk in younger and older adults alike (7–9) and can positively impact quality-of-life outcomes, such as stress responses, depressive symptoms, and sleep quality, which are of particular relevance to older caregivers (10–14). Despite the many benefits of regular moderate-intensity physical activity, less than 25% of middle- and older-aged adults, including older family caregivers, are regularly active enough to achieve these benefits (6,7). The majority of physical activity programs for middle- and older-aged adults occur in community-based settings, which can pose significant challenges for caregivers, who often face subM26 stantial time and logistical constraints (6,15). Telephonesupervised, home-based, physical activity regimens are effective alternatives to group-based regimens and provide a promising strategy for increasing physical activity in the caregiving population (16). The current study represents the first systematic investigation of the effectiveness of a physical activity intervention tailored to the challenges and needs of family caregivers. We investigated the following hypotheses: (i) The home-based physical activity intervention would result in significantly greater 1-year increases in physical activity levels relative to an attention-control (nutrition education) condition. (ii) Caregivers randomly assigned to the physical activity intervention would demonstrate significantly reduced cardiovascular reactivity levels at 1 year in response to an emotional challenge relative to controls. Such reactivity represents one potential pathway mediating the relationship between physical inactivity and negative cardiovascular outcomes (17–20). Notably, blood pressure elevations related to the caregiving situation have been reported in at least one study comparing women caregivers with noncaregivers (11). (iii) Caregivers randomly assigned to the physical activity intervention would report significantly enhanced quality-of-life outcomes relative to controls. Psychological distress and rated sleep EXERCISE INTERVENTION WITH FAMILY CAREGIVERS quality were selected due to their particular relevance to older caregivers (21,22), and also because the literature indicates positive physical activity–related impacts on these outcomes (10,13). In addition, we predicted that caregivers randomly assigned to the nutrition education condition would show better dietary patterns at 1 year relative to caregivers assigned to the physical activity intervention. Healthful dietary patterns represent an additional important health behavior domain strongly linked to premature morbidity and mortality (23,24). We targeted older women caregivers of relatives with dementia in light of this increasingly prevalent and challenging caregiving circumstance, undertaken primarily by older women (21,25,26). METHODS Participants Participants were 100 women (47 adult children caregivers and 53 spousal caregivers) who had enrolled in the Teaching Healthy Lifestyles for Caregivers study. Eligibility criteria for the major trial were as follows: postmenopausal; 50 years of age or older (could be 46–49 years if participant was postmenopausal due to a complete hysterectomy); a woman caregiver (defined as providing care in one’s home for a relative with Alzheimer’s disease or another form of dementia, as documented by the care recipient’s physician); providing at least 10 hours of unpaid care per week; not planning to move from the area during the next year; free from any medical conditions that would limit participation in moderate-intensity exercise (e.g., walking); not participating in a regular program of physical activity (i.e., less than three times per week of exercise lasting 20 minutes per session over the past 6 months); and stable on all medications for at M27 least 3 months prior to study entry. Recruitment occurred via community-wide promotion, including use of an array of media sources as well as referrals from physicians and organizations serving older adults and caregivers. A summary of enrollment patterns is shown in Figure 1. Procedures During the 1-week period prior to randomization and following the attainment of informed consent, participants underwent medical, physical, and psychosocial assessment (repeated at 1 year). The assessment included an electrocardiogram- (ECG-) monitored, symptom-limited, graded treadmill exercise test using a Balke-type protocol with workloads increasing by approximately 1.0 to 2.0 metabolic equivalents every 2 minutes (27). Individuals with baseline evidence of exercise-induced ischemia, determined by physician review of the ECG, were excluded from study participation. Three individuals were excluded because of a positive treadmill test. Following baseline evaluation and stratification by relationship to care recipient (i.e., spouse vs other) and care recipient dementia diagnosis (Alzheimer’s disease vs other forms of dementia), participants were randomly assigned to one of two conditions using a computerized version of the Efron procedure (28): (i) a 12-month moderate-intensity endurance exercise training program or (ii) a 12-month attention control (nutrition education) condition. Nutrition education has been found to provide an effective control for staff attention and participant expectancy effects when evaluating physical activity–related outcomes (29,30). Physical activity condition.—Each participant randomly assigned to the exercise training program was provided an exercise prescription in which exercise intensity was gradu- Figure 1. Progress through the various stages of the trial, including flow of participants, withdrawals, and timing of the outcome measures. The “R” indicates randomization. M28 KING ET AL. ally increased over the initial 6-week period to 40% to 59% of heart rate reserve based on the peak heart rate achieved during symptom-limited treadmill testing (31). Participants were instructed to engage in at least four 30- to 40-minute exercise sessions per week of primarily brisk walking, in a home-based format, throughout the 12month period. Participants were also encouraged to increase other forms of routine activity throughout the day, such as leisurely walking and gardening. During a 30- to 40-minute introductory session, following randomization, a project health educator provided instruction on the exercise program to be initiated. Each participant worked with the health educator to develop an individualized physical activity plan based specifically on her physical activity preferences and particular caregiving situation. The majority of participants randomized to exercise chose to engage in brisk walking in their immediate neighborhoods (76%). For the 12 participants who could not leave or find coverage for their care recipient for 30 minutes during the day, an indoor activity program was developed based on the participant’s preferences. Indoor programs included stationary cycling or use of project-provided exercise videotapes. Participants were instructed in how to take their heart rates and monitor their perceived exertion during exercise using the Borg scale (32). They recorded this information on activity logs, which were used by the health educators to counsel them on how to increase their exercise frequency, intensity (e.g., pace), and duration. Written information was provided, and the staff member telephoned the participant at home the following week to check on progress. Telephone contact, beginning the week following randomization, occurred on a biweekly basis during the first 2 months, and then once monthly through 12 months (for a total of 14 calls throughout the intervention period). Telephone contacts, which lasted an average of 15 to 20 minutes, were used to monitor progress, answer questions, and provide individualized feedback. Participants completed brief daily logs to record home-based physical activities, including activity type, intensity, and duration, which were mailed back to the project staff monthly. Attention-control (nutrition education) condition.— Participants randomized to this condition received a telephone-based nutrition education program that was matched with the physical activity program on the amount and type of staff contact received (introductory session describing the nutrition program and 14 telephone contacts). The nutrition program was based on recommendations from the American Heart Association, and similar organizations, for a heart-healthy diet (33). National dietary recommendations aimed at reducing the total percentage of calories from fat to less than 30% were used along with dietary guidelines aimed at increasing fruit and vegetable intake (34). Participants completed brief daily nutrition logs, which were mailed back to the project staff monthly. During each month of the intervention period, a different nutrition topic was targeted for monitoring and intervention (e.g., high-fat snack, fruit, and vegetable intake). Participants were given homework assignments to complete specific to each topic (e.g., trying certain recipes and label-reading assignments). For both conditions, health educators utilized behavioral strategies based on social cognitive theory to enhance behavioral adherence (35). These included discussion of the benefits associated with behavior change, specific goal-setting, regular self-monitoring and feedback, topic-specific educational materials, and relapse prevention training (35,36). Measurement Procedures Demographics.—Participants completed a measure of demographic characteristics, including their age (in years), marital status, ethnicity, education (in years), and employment status (22). They were asked to note the number of prescribed medications that they were currently taking, as well as the number and type of chronic conditions. They also rated their health on a 5-point Likert scale taken from the Medical Outcomes Study Short-Form General Health Survey (37). Participants were asked, “In general, would you say your health is excellent [5 points], very good [4 points], good [3 points], fair [2 points], or poor [1 point]?” Caregiving characteristics.—Participants completed a survey focused on different aspects of their caregiving experience (6). Items included their familial relationship to the care recipient, age and diagnosis of the care recipient (confirmed by the care recipient’s physician), length of time as a caregiver, and average hours per week spent caregiving. Caregiver burden was assessed for descriptive purposes with the 25-item Screen for Caregiver Burden (38–40). Average scores for family caregivers on this scale typically have been reported to be between 9 and 11 for objective burden and between 35 and 37 for subjective burden (38,41). The level of behavioral problems evidenced by participants’ care recipients was measured using the Revised Memory and Behavior Problems Checklist (RMBPC), a 24item caregiver-report measure of observable behavioral problems in dementia patients (42). The caregiver’s perception of such behavioral problems has been found to be a stronger predictor of caregiver burden, institutionalization, and related factors than other care recipient factors, such as cognitive impairment or functional limitations (43). The measure provides one total score and three subscale scores for patient problems (memory-related, depression, and disruptive behaviors) and parallel scores for caregiver reaction (42). The RMBPC has been found to be a valid and reliable instrument for assessing behavior problems in dementia patients (42). The average frequency score for the total scale has been reported to be 34 (possible range, 1–87). The average reaction score for the total has been reported to be 23 (possible range, 0–77) (42). Assessment of exercise adherence.—Average monthly adherence rates across the 12-month period were calculated for subjects randomized to the physical activity condition as follows: number of exercise sessions reported (based on activity logs described earlier) as a percentage of exercise sessions prescribed for the month. Approximately 20% of participants were randomly selected to wear a solid-state two-channel portable microprocessor (Mini-Logger Series 2000, Mini Mitter Company, EXERCISE INTERVENTION WITH FAMILY CAREGIVERS Inc, Sunriver, OR), which recorded heart rate and body movement continuously throughout the day for up to a 3-day period during the course of the study. This and similar solidstate portable microprocessors provide a valid and reliable indicator of adherence to prescribed exercise (44–46). Physical activity assessment.—To assess change in physical activity levels, participants completed the Community Health Activity Model Program for Seniors (CHAMPS) physical activity questionnaire for seniors (47,48). This 47item self-report instrument, which summarizes frequency and duration of a range of activities undertaken during the previous month, has been found to provide a valid and reliable estimate of energy expenditure in older adults (47,48) and is sensitive to change in response to moderate-intensity physical activity interventions (31,47,48). Cardiovascular reactivity to emotional challenge.— Caregivers underwent a laboratory-based emotional challenge to evaluate levels of cardiovascular reactivity. Participants were instructed to refrain from caffeine intake or physical exercise the morning of the emotional challenge. The protocol began with a 10-minute rest period during which time the participant sat alone quietly in a room and listened to relaxing music via headphones (baseline). Following that period, a trained research assistant engaged the participant in 2 minutes of neutral conversation and then directed the participant to speak for about 6 minutes about the aspects of her caregiving experience that she found to be most frustrating or disturbing. The research assistant made minimal verbal responses during the task period. Following the 6-minute task period, the research assistant left the room, and the participant rested for an additional 10 minutes (the recovery period). Heart rate and blood pressure recordings were collected every 2 minutes from the beginning of the baseline period through the recovery period through use of a Colin ambulatory blood pressure monitor (model ABPM630, Colin Medical Instruments, Plainfield, NJ) attached to the nondominant arm. The recordings were averaged within each portion of the emotional challenge (i.e., baseline, task, and recovery) to obtain mean heart rate, systolic blood pressure, and diastolic blood pressure levels. Reactivity levels were obtained by subtracting the mean baseline from mean task levels for each hemodynamic variable. Speaking tasks involving emotionally relevant content have been shown to provide a reliable means of eliciting elevations in hemodynamic variables in a variety of populations of women (49), including caregivers (50). Rated sleep quality.—The 19-item Pittsburgh Sleep Quality Index (PSQI) was used to evaluate self-rated sleep quality at baseline and at 1 year (51). This questionnaire assesses sleep quality and disturbances over a 1-month time interval and generates seven “component” scores. Three components found in previous research with older adults to be sensitive to change with moderate-intensity physical activity were of interest (13): subjective sleep quality (possible subscale score, 0–3), sleep latency (i.e., average time in minutes needed to fall asleep), and sleep duration (i.e., average number of hours of actual sleep per night). An average M29 score on the sleep quality subscale for a sample of healthy middle- to older-aged adults without sleep complaints has been reported to be 0.35 (lower scores on this scale indicate better sleep) (22,51). Middle- and older-aged adults in the general population typically report a sleep duration of between 7 and 8 hours per night and a sleep latency of less than 20 minutes (52,53). Rated psychological distress.—The psychological distress domain included measures of rated stress and depressive symptoms. Rated stress was measured using the Perceived Stress Scale (PSS) (54), a 14-item scale that measures the degree to which situations in one’s life are appraised as stressful. The PSS has been found to have adequate internal and test-retest reliability and is positively correlated with a variety of self-report and behavioral indices of stress in adult populations (54,55). Average scores on this scale for healthy adult noncaregiving populations typically range from 17 to 25 (10,54,56). The average score in a study of older women caregivers was reported to be 29 (6). Depressive symptoms were measured using the Beck Depression Inventory (BDI) (57), a valid and reliable 21-item inventory that has been used extensively to measure depression and distress in a variety of populations (58,59). Average scores for nondepressed groups of middle- and olderaged adults typically are less than or equal to 6 (10,56). Dietary assessment.—Participants completed the Block95 Food Frequency questionnaire, 1995 version, which is a revised version of the Health Habits and History questionnaire (60,61). Participants self-report the average frequency of consumption of 90 foods and average serving sizes over the past year. The correlations between versions of this questionnaire and 4-day dietary records ranged from 0.42 to 0.71 (60,61). The National Cancer Institute’s DIETSYS program was used to derive estimates of dietary nutrients and frequency of various food groups (62). Based on the nutrition intervention, dietary components specifically targeted by the assessment were the percentage of calories derived from total fats and saturated fats, the intake of high-fat snacks and sweets, and fruit and vegetable intake. A food frequency questionnaire was chosen rather than alternative instruments (e.g., dietary records or repeat 24hour dietary recalls), due to subject burden and cost issues. The Block95 Food Frequency questionnaire was used in light of its inclusion of food items particularly germane to individuals living in the western United States. Statistical Analyses Analysis of covariance (ANCOVA) was used to assess changes during the 1-year period in the variables of interest (general linear model) (63). The main effects for group assignment were evaluated, with baseline levels of the dependent variable and relation to care recipient (spouse vs other) and care recipient diagnosis (Alzheimer’s disease vs other) serving as covariates. Two-way interactions between group assignment and the latter two covariates were also evaluated. These interactions were undertaken in light of the potential differences in caregiver–care recipient relationship factors, as well as in dementia time course, which could in- M30 KING ET AL. fluence caregiver burden and, consequently, intervention outcomes. The least-squares means method was used to compare group means for all significant effects (64). For the psychological distress domain and rated sleep domain in which several measures or subscales were collected, a multivariate ANCOVA (MANCOVA) was first used as an omnibus test incorporating the relevant scales. Following a statistically significant MANCOVA, ANCOVA procedures were conducted for each measure or subscale. The level for all tests was set at .05. A one-tailed test of significance was applied for tests of major hypotheses in light of the directional nature of the posited hypotheses (65,66). For other descriptive analyses, two-tailed tests of significance were applied. RESULTS Subjects Fifty-one caregivers were randomized to the physical activity condition and 49 to the nutrition control condition. A description of the study sample is shown in Table 1. Caregivers were an average of 63 years old (range, 49–82 years). Of these, 86% were white. Participants were living with their care recipients either all (92%) or most (8%) of the time throughout the week. They had spent an average of 4 years caring for their impaired relative, 63% of whom had received a diagnosis of Alzheimer’s disease. The mean age of the care recipients was 80 years. Caregivers reported spending an average of 72 hours per week undertaking caregiving duties. These caregiving characteristics are similar to those of samples of caregivers studied previously (6). As expected, the levels of psychological distress observed in this sample (shown in Table 1) are higher than typically observed in similarly aged noncaregiving samples (10,22). For example, the mean baseline BDI score places this sample in the mild depression category (scores of 10–15) on that clinical measure (67), which is similar to other samples of caregivers reported in the literature (6,38,68). This mean score is twice that found in comparably aged samples of noncaregiving women living in the same locale (10). In addition, the sample’s scores on the PSS averaged 10 points (i.e., 1 SD) higher than scores found in comparably aged samples of noncaregiving women living in the same locale (10). In evaluating the descriptive data at baseline, caregivers randomized to the nutrition program had somewhat higher initial levels of depressed affect and subjective burden, and a somewhat smaller percentage were currently employed. Exploratory analyses of covariance evaluating the interaction between these baseline variables and group assignment indicated no differential impacts of these small baseline differences on any of the outcomes of interest. Information collected about care recipient functioning via the RMBPC is shown in Table 1. The means for the total and subscale scores were quite similar to those reported in the literature (42). The two conditions were comparable on this measure at baseline and at 12 months, with both groups showing modest (nonsignificant) changes in this measure across the year. Changes in this scale across the year were not significantly correlated with changes in either the physical activity or dietary measures (Spearman correlation coef- Table 1. Descriptive Statistics† at Baseline and 12 Months for Variables of Interest, by Condition Assignment Variable Physical Activity Nutrition Education Control 90% Confidence Intervals‡ n 45 40 — Age, y 62.2 (9.3) 63.3 (9.0) — Education, y 15.4 (2.2) 14.6 (2.8) — Currently employed, % 37.7 27.5 — Wife caregiver, % 55.6 50.0 — Alzheimer’s care recipient diagnosis, % 64.7 63.3 — Antihypertensive medication use, % 27.5 30.6 — 27.8 (4.8) 26.9 (5.6) — Body mass index, kg/m2 At 12 mo 27.9 (5.2) 26.9 (5.3) — Resting systolic BP, clinic 117.3 (13.8) 123.2 (14.0) — At 12 mo 118.0 (15.2) 121.6 (15.0) — Resting diastolic BP, clinic 69.6 (6.7) 68.0 (7.4) — At 12 mo 68.8 (8.6) 66.5 (9.3) — Objective burden score 11.5 (3.7) 12.6 (4.0) — At 12 mo 10.8 (3.6) 11.8 (4.8) — Subjective burden score 39.6 (9.4) 43.7 (9.8) — At 12 mo 35.7 (7.5) 40.9 (12.8) — Revised memory and behavior problems checklist Total frequency ratings score 39.9 (12.7) 39.1 (14.3) — At 12 mo 39.7 (15.3) 39.9 (15.4) — Frequency, memory problems 19.8 (4.2) 20.4 (6.3) — At 12 mo 23.9 (7.8) 23.3 (5.4) — Frequency, depressive symptoms 12.6 (7.3) 11.3 (7.8) — At 12 mo 10.4 (7.2) 9.5 (7.0) — Frequency, disruptive behaviors 7.5 (5.8) 8.3 (5.7) — At 12 mo 6.4 (4.0) 7.1 (5.8) — Total reaction ratings score 24.6 (15.4) 25.5 (10.3) — At 12 mo 23.6 (15.4) 23.0 (12.1) — Reaction, memory problems 11.4 (5.6) 10.3 (4.5) — At 12 mo 9.1 (6.4) 9.2 (4.7) — Reaction, depressive symptoms 10.3 (7.9) 7.3 (5.2) — At 12 mo 9.6 (7.5) 7.3 (6.2) — Reaction, disruptive behaviors 9.5 (7.2) 8.0 (5.7) — At 12 mo 6.0 (4.2) 6.5 (5.6) — Outcomes of Interest Physical activity Total energy expenditure, kcal/kg/d 1.4 (1.9) 1.2 (1.7) At 12 mo** 2.2 (2.2) 1.2 (1.6) 1.1 to 2.6 Total time spent in all 3.1 (3.8) 2.8 (3.6) physical activity, h/wk§ At 12 mo** 5.0 (4.9) 2.9 (3.7) 1.2 to 3.6 Cardiovascular reactivity Systolic BP reactivity, mm hg 21.6 (12.3) 17.9 (10.2) At 12 mo** 12.4 (11.2) 17.7 (13.8) 11.6 to 1.1 Diastolic BP reactivity, mm hg 10.6 (6.6) 10.5 (5.4) 5.5 to 1.3 At 12 mo** 6.6 (5.4) 9.6 (7.1) Heart rate reactivity, beats/min 7.6 (4.9) 6.8 (5.2) 3.5 to 0.2 At 12 mo 6.1 (4.6) 7.2 (5.1) Continued on next page EXERCISE INTERVENTION WITH FAMILY CAREGIVERS Table 1. Descriptive Statistics† at Baseline and 12 Months for Variables of Interest, by Condition Assignment (Continued) Variables Sleep quality Rated sleep quality subscale score At 12 mo* Sleep duration, h/night At 12 mo Sleep latency, min to fall asleep At 12 mo Psychological distress Beck Depression Inventory score At 12 mo Perceived stress scale score At 12 mo Reported dietary intake Total calories from fat, % At 12 mo*** Total calories from saturated fat, % At 12 mo*** Fat/oils/sweets/snacks, frequency/d At 12 mo*** Vegetables, frequency/d At 12 mo Fruits, frequency/d At 12 mo Physical Activity Nutrition Education Control 1.1 (0.8) 0.9 (0.8) 6.6 (1.0) 5.5 (2.9) 1.1 (0.6) 1.2 (0.8) 6.6 (1.3) 6.2 (2.1) 90% Confidence Intervals‡ 0.6 to 0.1 1.7 to 0.3 22.0 (23.8) 20.9 (23.3) 29.8 (39.4) 29.7 (32.1) 10.4 to 4.7 10.7 (6.5) 7.4 (4.8) 13.7 (6.3) 9.4 (7.2) 0.1 to 3.6 28.1 (8.3) 24.8 (8.1) 29.3 (6.8) 26.6 (8.5) 2.6 to 2.9 31.6 (5.7) 31.8 (6.3) 33.3 (6.9) 29.6 (8.3) 1.1 to 6.0 10.2 (2.3) 10.3 (2.2) 10.9 (2.7) 9.5 (2.9) 1.5 to 3.2 2.7 (2.0) 2.3 (1.3) 2.7 (0.9) 2.7 (1.2) 2.0 (1.1) 2.1 (1.3) 2.2 (1.4) 1.5 (1.2) 2.6 (1.1) 2.8 (1.1) 1.6 (0.9) 2.1 (1.0) 1.2 to 2.3 0.5 to 0.2 0.6 to 0.1 Note: BF blood pressure. †Means (SD), frequencies. ‡Confidence intervals for outcomes of interest represent a measure of precision for the mean 12-mo difference between treatment and control conditions, adjusted for baseline value, relation to care recipient, and care recipient diagnosis. §Includes light, moderate, and vigorous forms of physical activity. For the sleep quality subscale, a decrease represents improvement. *Physical activity condition different from nutrition condition at p .05. **Physical activity condition different from nutrition condition at p .03. ***Physical activity condition different from nutrition condition at p .01. ficients .30). This suggests that the targeted interventions were able to promote changes in these health behaviors across the year, irrespective of any changes that were occurring in care recipient behaviors during that period. Fourteen caregivers experienced the institutionalization or death of their care recipient during the study (comparable numbers in each condition), with the majority of these incidences occurring toward the end of the 1-year intervention. Individuals continued to receive exercise or nutrition counseling as indicated by their condition assignment. There were no significant differences between this subgroup and the rest of the sample with respect to either physical activity or dietary behaviors at the end of the intervention. The total energy expended by the sample in all forms of physical activity at baseline averaged less than 100 kcal per day, an amount that is less than current nationally recommended goals for physical activity (7). In addition, the sample spent an average of 85 minutes per week in activities of M31 at least moderate intensity, in contrast to the surgeon general’s recommendations to spend at least 150 minutes per week in such activities (7). Participants’ baseline V̇O2max levels averaged 22.4 3.9 ml/kg/minute, which reflects fitness levels comparable to other similarly aged populations of women not engaged regularly in vigorous forms of activity (7,36). With respect to general health status, the mean score on the self-rated health question was 3.3 (range, 1–5), which places the sample in the “good” category (percentage choosing “poor” 1.1%, “fair” 12.5%, “good” 48.6%, “very good” 31.8%, and “excellent” 6.0%). The average number of chronic conditions reported by caregivers was 1.1 (range, 0–4). The most prevalent conditions were arthritis (36% of the sample), hypertension (29%), and chronic pulmonary disease (14%). Participants were taking an average of 1.9 prescribed medications per day (range, 0–6). Eighty percent of the women in both conditions were taking at least one medication daily. The most common medications were hormone replacement therapy (HRT; n 47), antihypertensives (n 29), and thyroid medication (n 19). The two conditions were comparable on these health factors at baseline. The 12-month data were collected on 85% of the sample (comparable percentages by study condition, relationship to care recipient, and type of dementia diagnosis). Participants who contributed 12-month data (n 85) were comparable to those who did not (n 15) on all but three baseline variables of interest ( p values .02): Those lacking 12-month data reported more baseline hours per week spent in caregiving duties (mean, 100.5 41.7 vs 66.2 45.4 hours) and were significantly more depressed (mean score, 16.2 8.2 vs 11.6 6.1) and stressed (mean score, 33.5 4.8 vs 27.9 7.7) at baseline relative to those who returned at 12 months. Changes on the outcomes of interest for each condition are presented in Table 1. Exercise Adherence Among participants randomized to the physical activity condition, adherence to the exercise prescription across the 12-month period averaged 73.4% 31% of prescribed exercise sessions completed (range, 9%–150%), with an average reported duration of 35.8 23.0 minutes per session. This level of physical activity adherence is similar to that obtained in noncaregiving groups of older adults using telephone-supervised home-based formats (16). The increase in physical activity among subjects in the exercise condition was reflected in the ambulatory heart rate and activity recording data. For the 9 exercise subjects randomly selected to wear the 3-day ambulatory heart rate and activity monitor, there was an 87.5% agreement rate between continuous bouts of physical activity within the moderate-intensity target heart rate range as recorded by the monitor as well as on the participants’ logs. In addition, 2 of the participants reported physical activity bouts of sufficiently long duration, but which failed to reach the targeted exercise heart rate range. The exercise session duration in the prescribed heart rate range as measured by the heart rate and activity monitor averaged 32.8 20.3 minutes. M32 KING ET AL. Change in Physical Activity Levels As hypothesized, caregivers assigned to the physical activity condition reported a significantly greater total daily energy expenditure at 12 months (baseline-adjusted 12month mean, 2.1 kcal/kg/day) relative to caregivers assigned to nutrition (adjusted mean, 1.3 kcal/kg/day; F[6,77] 4.1, p .02). This translated into an adjusted mean of 5.0 hours per week in all forms of physical activity for those in the physical activity condition (adjusted mean, 2.9 hours/week for nutrition condition; F[6,77] 4.8, p .02). Approximately half of those 5 hours (adjusted mean, 2.4) came from moderate-intensity activities (primarily brisk walking), with the other half (adjusted mean, 2.6) spent in more routine forms of lighter activity, such as leisurely walking and gardening. For the average-weight participant in this study (mean body weight, 74 kg), this amount of daily energy expenditure translates into approximately 1088 kcal/week expended in physical activity among physical activity participants. There were no changes in fitness levels based on treadmill testing as a consequence of this moderate-intensity physical activity program (69). Neither were there changes in resting blood pressure levels in this initially normotensive sample of women. Change in Cardiovascular Reactivity in Response to an Emotional Challenge As hypothesized, caregivers assigned to physical activity showed significantly lower 12-month systolic and diastolic blood pressure reactivity levels in response to the emotional challenge relative to nutrition controls (p values .03). These results are shown in Figure 2. No significant between-group differences were found for 12-month heart rate reactivity, or during the baseline or recovery periods for the three variables. Two ANCOVAs were also undertaken to evaluate the effects of antihypertensive medication and HRT use, and their Figure 2. Twelve-month reductions in stress-induced systolic and diastolic blood pressure (BP) reactivity levels, by condition (means, SE; conditions significantly different at post-test, *p .05). interactions with condition assignment, on blood pressure and heart rate reactivity. The results were identical to those reported previously, with none of the antihypertensive medication or HRT effects achieving statistical significance (p values .10). (Approximately 47% of participants in each condition were on HRT.) Change in Rated Sleep Quality The MANCOVA evaluating the overall 12-month between-group differences in the three sleep variables was significant (F[3,68] 2.4, p .039). Rated sleep quality was significantly better at 12 months in the exercise condition (adjusted mean score, 0.87) relative to the nutrition condition (adjusted mean score, 1.2; F[6,74] 2.9, p .045). (Note that a lower score on this subscale denotes better sleep quality.) Among exercisers, improvement in rated sleep quality was significantly associated with 12-month reductions in perceived stress (Spearman rank r .33) and subjective caregiver burden (r .33; p values .04). There were no significant group differences in either the sleep duration or sleep latency variables (see Table 1). Change in Psychological Distress The MANCOVA evaluating the overall 12-month between-group differences on the PSS and the BDI did not reach statistical significance. Within-group paired comparison t-test analyses, undertaken for descriptive purposes, indicated that both groups improved over the 12-month period on these two psychological outcomes (p values .05; see Table 1). Change in Dietary Patterns As hypothesized, caregivers assigned to the nutrition condition reported a significantly lower percentage of total calories from fat at 12 months (baseline-adjusted 12-month mean, 29.1%) relative to caregivers assigned to the physical activity condition (baseline-adjusted mean, 32.6%; F[6,68] 5.3, p .01). They also reported a lower percentage of calories from saturated fats at 12 months (baseline-adjusted 12-month mean, 9.3%) relative to exercisers (baselineadjusted mean, 10.6%; F[6,68] 7.5, p .004). Similarly, caregivers assigned to the nutrition condition reported a significantly lower daily intake of fats, oils, sweets, and highfat snacks (baseline-adjusted mean, 1.6 servings/day) relative to exercisers (baseline-adjusted mean, 2.2 servings/day; F[6,68] 5.5, p .01). For both conditions, there were relatively modest changes in average daily total caloric intake across the year (baseline and 1-year means for exercise condition: 1756.5 520.5 and 1699.0 604.7 kcal, withingroup difference not significant; baseline and 1-year means for nutrition condition: 1700.2 656.5 and 1432.4 411.2 kcal, within-group difference significant at p .03; no significant differences were found between conditions). Such modest changes typically are insufficient, either alone or in combination with a moderate-intensity walking program, to promote significant weight loss in middle- and older-aged women without specific, sustained efforts to restrict caloric intake (7,70,71). It should be noted that weight loss was not a goal of either of the interventions. Related to this point, the measures of self-reported dietary and physical activity EXERCISE INTERVENTION WITH FAMILY CAREGIVERS behaviors used in this study, while appropriate for evaluating relative changes in behavioral patterns over time, lack the high level of precision required for evaluating specific contributions to energy balance (61,72). A significant interaction effect was found for daily vegetable intake at 12 months (F[6,68] 5.2, p .01). Daughters assigned to nutrition evidenced greater vegetable intake (adjusted mean, 3.1 servings/day) than daughters assigned to physical activity (adjusted mean, 2.4, p for pairwise comparison .04). No significant effects were found for 12month fruit consumption. Exercise-related Injuries Exercise-related injuries (reported at assessments, on logs, and during the telephone contacts) were minimal (reported by 10% of subjects), and none were severe enough to require study termination. The most frequent exercise-related symptoms (constituting approximately three fourths of those reported) were muscle soreness and minor pain around the joints, and these were quickly resolved with an adjustment of the exercise program and instructions for self-care. DISCUSSION To our knowledge, this is the first study to show that interventions tailored to the situational constraints of caregiving result in significant, sustained improvements in health behaviors critical to caregiver health and functioning (5). Wife and daughter caregivers assigned to the moderateintensity home-based physical activity program showed significant increases in physical activity–related energy expenditure, averaging over 1000 kcal per week at 12 months, relative to those assigned to the attention-control (nutrition) condition. This amount of weekly physical activity is commensurate with the amount currently being recommended for middle- and older-aged adults to achieve important health and functioning benefits (7,73). The amount of physical activity achieved was sufficient to result in significant 12-month reductions in stress-induced blood pressure reactivity among those assigned to physical activity relative to controls. Stress-induced cardiovascular reactivity has been postulated as one potential pathway mediating the relationship between chronic stress and cardiovascular outcomes (20,74,75). The physical activity–associated decreases in blood pressure reactivity levels observed, which may reflect a down-regulation of sympathetic activity (20), were substantial relative to other studies in this area (19,75). Caregivers assigned to the physical activity condition also reported significant 12-month improvements in rated sleep quality relative to controls. This is notable given that, although family caregivers as a group tend to suffer from poor sleep (22), the subjects in this study were not selected based on their level of sleep complaints. This made it potentially more difficult to detect sleep quality improvements across this subject sample (13). These results add to the small body of literature indicating improvements in self-rated sleep among older adults with the introduction of a moderateintensity home-based physical activity program (13). Although there were no appreciable increases in fitness as measured by the treadmill exercise test, a growing amount of evidence in this area has shown that this is to be M33 expected when the exercise stimulus is of a more moderate intensity, such as walking, and the target group is of older age (69). An increasing number of studies are now available demonstrating that older adults can achieve significant health benefits from these more moderate levels of activity, irrespective of changes in V̇O2max or other fitness parameters (9,76–78). The information, obtained from the physical activity logs as well as the heart rate and activity monitors, indicated that participants were exercising at a level suitable for obtaining such health benefits. Caregivers assigned to the nutrition education program evidenced significant 12-month improvements in the percentage of total calories reported from all fats as well as saturated fats to below the recommended 30% and 10% levels, respectively (79). These changes were similar to those reported in other 1-year dietary intervention studies, many of which involved more intensive interventions (80,81). Significant reductions were also observed in daily servings of fats, oils, sweets, and high-fat snacks. The nutrition program represents one of the few systematic attempts to deliver ongoing nutrition counseling via telephone as opposed to face-to-face formats (82). The study results provide a starting point for the continued development of nutrition programs tailored to the needs of different caregiver subgroups (i.e., caregivers of other patient populations). The telephone delivery format used for both health behavior programs has been shown to be a convenient, flexible, and potentially low-cost alternative to the more traditional group-based health promotion programs offered in the community (16,83). Participants received a 30- to 40minute face-to-face introductory counseling session, with the remainder of the program delivered via biweekly, then monthly, telephone and mail contacts. Studies with other populations suggest that this frequency of telephone contact could potentially be reduced once the program is established (84,85). Volunteer and service organizations operating through health centers and other settings could deliver this type of support (16). Although the inclusion of an attention-control condition allowed us to rule out subject expectancy effects related to a number of the outcomes of interest, the lack of a wait-list or assessment-only condition prevents a clear interpretation of the improvement in psychological distress outcomes noted in both conditions. The improvements shown in both groups on the depression and stress outcomes were notable (10) (e.g., at 12 months, participants in both conditions had reduced their BDI score to below the cut point often used for mild depression) (67). However, evaluation of the relative efficacy of health behavior interventions compared with psychosocial interventions aimed specifically at reducing psychological distress in caregivers awaits study designs that explicitly compare such different interventions directly (43). The pre- to post-test changes in psychological distress observed could be due to actual improvement stemming from participation in a health promotion program, regardless of content, or to repeat testing or other time-related impacts. Unfortunately, the documented difficulty of maintaining caregivers in wait-listed or assessment-only control conditions, even for short time periods (86,87), prevented the use of that type of control condition in the current study. M34 KING ET AL. In addition, although the 85% 12-month response rate is similar to 12-month return rates for other, noncaregiving older adult samples (31,88), nonreturning caregivers were more distressed and reported a greater number of hours spent in caregiving duties at baseline relative to those who returned for clinical assessment. These results are similar to those from a study evaluating dementia caregivers who required assessment in their homes as opposed to in a university setting (89). In that study, those assessed at home were more depressed and provided more hours of care per day than those who could attend clinic-based assessments. Continued efforts to reach this particularly distressed caregiver segment are indicated. Other limitations of the study include the fact that the sample was primarily white and well educated, limiting the generalizability of the results for more ethnically diverse caregiving populations. We conclude that properly tailored health promotion programs can promote sustained improvements in health behaviors that are important to the ongoing health and functioning of older women family caregivers. The crucial and increasingly prevalent societal role that family caregivers play in providing an alternative to institutionalization exacts a tremendous physical, emotional, and economic cost for the caregiver herself and provides the rationale for continued development of programs to preserve both the caregiver’s health and quality of life. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. Acknowledgments This research was supported by the National Institute on Aging (Public Health Service grant AG-12358). Statistical support was provided by David Ahn, PhD. We thank Patrick Henderson, Debbie Flandermeyer, and Karen Bolen for their help with data collection. 22. Address correspondence to Abby C. 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