The Gerontologist Vol. 49, No. S1, S100–S107 doi:10.1093/geront/gnp075 Published by Oxford University Press on behalf of The Gerontological Society of America 2009. The Prescribed Amount of Physical Activity in Randomized Clinical Trials in Older Adults Judy Kruger, PhD,1,2 David M. Buchner, MD,2 and Thomas R. Prohaska, PhD3 Purpose: Over the past two decades, a consensus has formed that increasing physical activity and reducing sedentary behavior in older adults are important for physical and cognitive health. Although there is strong evidence that regular physical activity can prevent or delay the onset of many chronic diseases, a major concern is ensuring that older adults take part in adequate levels of physical activity. Design and Methods: This article describes the amount of physical activity prescribed between 1980 and 2005 to sedentary older adults enrolled in randomized controlled trials (RCTs) using MEDLINE, Health and Psychological Instruments, EBM Reviews, CINAHL, ERIC, PsychInfo, and Social Science Abstracts with the key words “exercise,” “physical activity,” and “older adult.” More than 13,502 research abstracts were reviewed, and 160 RCTs 12 weeks or more in duration with documented outcomes of physical activity were synthesized. Results: The average prescribed dose of aerobic activity provided by interventions for older adults was less than the recommended amount of 150 min or more per week of moderate-intensity physical activity. In interpreting the results of RCTs, there is an insufficient body of evidence on the relationship between physical activity and cognitive health. However, studies indicated that moderate-intensity physical activity had a positive effect on cognitive health. Implications: Given the broad consensus of a dose–response relationship between aerobic activity and a variety of health outcomes, the RCT literature appears to have underestimated the benefit of physical activity for previously 1 Address correspondence to Judy Kruger, PhD, Division of Nutrition, Physical Activity, and Obesity, Centers for Disease Control and Prevention, 4770 Buford Highway Northeast, K-46, Atlanta, GA 30341-3717. E-mail: [email protected] 2 Physical Activity and Health Branch, Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia. 3 Department of Community Health Sciences, School of Public Health, University of Illinois at Chicago. sedentary older adults because the prescribed dosages are not consistent with those recommended. Key Words: Physical fitness, Exercise, promotion, RCT, Cognitive function Health Regular physical activity provides substantial health benefits for older adults, which include reducing the risk for premature mortality from several common chronic diseases (i.e., cardiovascular disease and colon cancer) and lowering the incidence of functional limitations such as impaired walking (Keysor, 2003; U.S. Department of Health and Human Services [USDHHS], 1996). Physical activity also provides therapeutic benefits, and it is recommended as part of treatment regimens for such diseases as hypertension (American College of Sports Medicine [ACSM] Position Stand, 2004) and arthritis (American Geriatric Society, 2001). More recently, bouts of aerobic fitness training have been shown to improve cognitive function among sedentary older adults (Colcombe & Kramer, 2003). In spite of accumulating evidence that physical activity can delay the onset of many chronic conditions seen in adulthood, research has not advanced sufficiently to make specific recommendations to prevent Alzheimer’s disease and related disorders (Prohaska & Peters, 2007). However, recommendations related to physical activity are numerous, and have shifted their emphasis over the past 30 years from exercise guidelines for clinical practice (ACSM, 1978; American Heart Association [AHA], 1972, 1975) to the premise that moderate-intensity physical activity can improve overall health and lower the risk for disease (USDHHS, 1996, 2008). Given the aging of the U.S. population, it is of particular interest whether the average dose prescribed in randomized controlled trials (RCTs) is similar to the minimum amount of physical activity set forth in recommendations. S100 The Gerontologist During the 1970s, the AHA published two separate reports that suggested that higher levels of exercise training (i.e., an intensity of training equivalent to 60%–90% of maximum heart rate [HRmax]) would result in higher levels of physical fitness (ACSM, 1978). These first set of exercise recommendations (AHA, 1972, 1975), in addition to the ACSM (1978) recommendations, led to the development of the “exercise prescription” formula. This formula has been used by exercise specialists, physicians, and health care professionals in clinical practice to promote physical activity in terms of frequency, duration, intensity, and type of exercise. However, in the late 1980s and early 1990s due to findings from laboratory- and population-based scientific studies, physical activity recommendations shifted away from the emphasis on physical performance. In 1995, the Centers for Disease Control and Prevention (CDC) and the ACSM developed physical activity recommendations for public health that encouraged every adult to accumulate 30 min or more of moderate-intensity physical activity on most, preferably all, days of the week (corresponding to 5 or more days per week; Pate et al., 1995). Since the 1995 CDC/ACSM report was developed, it was commonly thought that moderateintensity physical activity less than 3 days per week, or less than 30 min per occasion, was considered insufficient to obtain health benefits. However, although the duration (30 min) was clear in this recommendation, the frequency (i.e., prescribed number of days) was vague and raised the question about whether most days of the week meant 4 or 5 days. Recently, after a comprehensive review of the physical activity literature, the USDHHS published the 2008 Physical Activity Guidelines for Americans, which stated that for substantial health benefits, older adults should participate in moderate-intensity physical activity of at least 150 min per week, in vigorous-intensity physical activity of at least 75 min a week, or in an equivalent combination of moderate- or vigorous-intensity physical activities; and the activity should be spread throughout the week (USDHHS, 2008). The 2008 guidelines also suggested that additional health benefits could be gained through greater amounts of physical activity; however, the recommendation of more than or equal to 150 min of moderateintensity activity was meant as a minimum amount of physical activity for health benefits and that older adults should be as physically active as their abilities and conditions allow. Vol. 49, No. S1, 2009 The RCT literature provides useful information on the impact of increasing the percentage of adults who meet these recommendations, in addition to the feasibility and risks of routinely recommending high volumes of physical activity to previously sedentary older adults. Because the RCT design provides the strongest evidence of whether an activity provides health benefits, understanding how the RCT literature on physical activity in older adults has evolved is of considerable interest. Moreover, because the benefits of activity depend upon the dose, the prescribed dose greatly influences the size of health benefits reported by RCTs. The purpose of this article was to systematically review the literature on aerobic physical activity prescribed to previously sedentary older adults enrolled in RCTs. The objectives are to review prescription patterns of RCTs relative to physical activity recommendations for public health, to quantify discrepancies, and to characterize the dose of activity prescribed in RCTs with measures of cognitive function. Methods The Evidence Based Exercise and Older Adult (EBEOA) database archives published research on physical activity interventions among communitydwelling adults (M age ≥60 years) with documented health outcomes. Detailed methods of the design and conceptual model of the EBEOA database are described elsewhere (Hong, Hughes, & Prohaska, 2008). Figure 1 briefly describes the overall search and selection strategy used in this article. A literature search was performed using Medline, Health and Psychosocial Instruments, EBM Reviews, CINAHL, ERIC, PsychInfo, and Social Science Abstracts from January 1980 to January 2000 using the key words “exercise,” “physical activity,” and “older adult,” and a request for English-language articles. Because the main outcome of interest was physical activity, abstracts and papers were excluded if they reported only a single bout of exercise, exercise stress/tolerance tests, pharmaceutical studies (i.e., testing the effects of a drug), or specific therapeutic exercise (i.e., inspiratory muscle testing), or those without documented physical activity outcomes. To obtain articles published from January 2000 to December 2005, the same criteria used to collect articles in the EBEOA database were applied. After a full review of the papers, 13,260 were excluded because (a) the mean age was less than 60 years, (b) the participants included were persons S101 Search strategy 1. Inclusion / exclusion criteria for abstracts English-language articles using keywords: ‘exercise’ ‘physical activity’ ‘older adult’ 12,312 / 1,190 EBEOA citations / Updated citations Excluded 9,978 / 610 EBEOA citations / Updated citations 2. Inclusion / exclusion criteria for papers 2,334 / 800 EBEOA citations / Updated citations Excluded 2,112 / 525 EBEOA citations / Updated citations 3. RCT papers with aerobic physical activity 222 / 275 EBEOA citations / Updated citations Excluded 102 / 153 EBEOA citations / Updated citations 4. Aerobic papers of moderate-intensity with frequency and duration 120 / 122 EBEOA citations / Updated citations Excluded 48 / 34 EBEOA citations / Updated citations 5. Aerobic interventions 12 weeks with documented outcomes 72 / 88 EBEOA citations / Updated citations Figure 1. Data selection strategy. younger than 60 years and there were no subanalyses by age, (c) there was no comparison group, (d) the exposure to physical activity was not well reported, or (e) the studies were not RCTs. Although this database included multiple physical activity intervention design components such as strength training, flexibility, and balance, for this synthesis, only RCTs with an aerobic physical activity component and documented outcomes (i.e., frequency, duration, intensity) were selected. Moreover, only aerobic RCTs of 12 weeks or more in duration were examined as the literature suggests that physical activity interventions of less than 3 months may not be sufficient to produce measurable health benefits (Colcombe & Kramer, 2003; Jorgensen, 1995). Specific outcomes for aerobic physical activity were the prescribed number of days per week (frequency), the number of minutes per exercise session (duration), and the targeted level of physical exertion (intensity). Categories of intensity (i.e., HRmax, peak oxygen uptake [VO2max], and ratings of perceived exertion [RPEs]) were adapted using the ACSM (1993) guidelines. For example, moderate intensity consisted of activities at 60%–79% of HRmax, at 50%–74% of VO2max, or at an RPE of 12–13. The average dose of physical activity prescribed in RCTs was examined by the year published, by characteristics of the older adult sample (i.e., healthy, with an existing chronic diseases, or frail), and by the inclusion of a measure of cognitive S102 The Gerontologist Table 1. Distribution of Randomized Clinical Trial Studies on Aerobic Activity of Moderate Intensitya Lasting 12 Weeks or More (n = 160) Among Adults (≥60 years) ≥150 min/week <150 min/week Years <30 min, <3 days, n (%) ≥30 min, 3–4 days, n (%) ≥30 min, ≥5 days, n (%) ≤1996 >1997 Total 11 (22) 39 (78) 50 30 (32.6) 62 (67.4) 92 5 (27.8) 13 (72.2) 18 Note: aStudies on moderate-intensity activity had older adults training at a maximum heart rate of 60%–79%, a peak oxygen uptake at 50%–74%, or a rating of perceived exertion of 12–13. function. Because the CDC/ACSM recommendations (Pate et al., 1995), and the surgeon general’s report (USDHHS, 1996), recognize that substantial health benefits result from a moderate amount of physical activity—in the range starting at 30 min or more on most days of the week—RCTs published prior to 1996 were compared with those published after 1996. Studies published in 1996 were included in the pre-1996 studies, as it is likely that recommended levels were adopted and published within the same year. For this synthesis, the final sample was 160 intervention studies that were conducted 12 weeks or more in duration and that prescribed moderate-intensity physical activity. Results Between 1980 and 2005, there was a steady increase in the number of aerobic studies targeting previously sedentary older adults. Table 1 presents evidence from moderate-intensity interventions 12 weeks or more in duration, with sufficient informa- tion on the frequency and duration of physical activity to categorize studies. Among the 160 RCTs, only 18 prescribed 150 min or more of moderateintensity physical activity, and most were published since 1997. The majority of the studies prescribed moderate-intensity physical less than 150 min in varying combinations to older adults. Table 2 shows the distribution of moderateintensity RCTs by health status of the sample. Among moderate-intensity RCTs lasting 12 weeks or more, 93 selected healthy older adults, 56 those with chronic disease, and 11 those who were frail as study participants. Since 1997, there has been an increase in the number of studies that published results using older adults with chronic disease (e.g., cardiovascular disease, chronic lung disease, and arthritis) as the sample population. The majority of these studies prescribed less than 150 min per week of moderate-intensity activity. Of the 160 RCTs, none of the trials trained frail older adults at recommended levels of physical activity (150 min or more per week). Table 2. Distribution of Year and Moderate-Intensitya Physical Activity Randomized Controlled Studies Lasting 12 Weeks or More Among Adults (≥60 years) by Characteristics of Sample (n = 160) Health status b Healthy , n (%) Chronic diseasec, n (%) Fraild, n (%) 30 (32.3) 63 (67.7) 10 (17.9) 46 (82.1) 6 (54.5) 5 (45.5) 27 (29.0) 55 (59.2) 20 (35.7) 29 (51.8) 3 (27.3) 8 (72.7) 11 (11.8) 93 7 (12.5) 56 0 (0.0) 11 Years ≤1996 >1997 <150 min/week <30 min, <3 days ≥30 min, 3–4 days ≥150 min/week ≥30 min, ≥5 days Total Notes: aStudies on moderate-intensity activity had older adults training at a maximum heart rate of 60%–79%, a peak oxygen uptake at 50%–74%, or a rating of perceived exertion of 12–13. b Sample selected based on being free of health problems and/or not selected based on the presence of a chronic illness. c Sample selected because of chronic disease of interest (e.g., arthritis, coronary heart disease, chronic obstructive pulmonary disorder). d Intervention study described sample as frail in the Methods section. Vol. 49, No. S1, 2009 S103 In recent years, there has been an increase in the number of RCTs that measure cognitive health outcomes. The present study found that only 4 studies examined cognitive outcomes in 1996, compared with 18 studies published in 1997 and beyond (Table 3). Among the studies that examined mental health outcomes, only three studies prescribed 150 min or more per week of moderateintensity activity. Almost all the 22 interventions in the sample were delivered three times per week, and in most cases, exercise sessions lasted at least 30 min. Of the interventions that were at least 12 weeks or more in duration, the most common cognitive health outcome used was the 36-item Short Form, mental health component. Discussion Public health recommendations have shifted away from a prescribed intensity to meeting a minimum recommended amount of aerobic activity that is spread throughout the week. The recommendations (ACSM, 1978; AHA, 1972, 1975) published in the 1970s were clinically oriented and recommended a much higher dose of physical activity (a duration of 15–60 min, a frequency of 3–5 days, an intensity of 60%–90% of HRmax) than the recommendations published in mid-1990s. The later recommendations consisted of physical activity levels of a less intense dose and placed greater emphasis on the health benefits (Pate et al., 1995; USDHHS, 1996). Conclusions from the present study suggest that RCTs typically prescribe less than the minimum levels of physical activity specified in public health recommendations. There are several plausible reasons as to why RCTs tend to prescribe lower amounts of physical activity than are recommended. Presumably, the prescribed frequency of 5 days rather than 3–4 days of activity may be more expensive and more difficult (because they require longer staff hours to administer trial procedures), and a study must simply be able to say that the dose of activity it has prescribed could plausibly result in the effects of interest—it does not necessarily need to relate the dose to a public health recommendation. Moreover, it is reasonable to demonstrate first that an effect exists, before endorsing dose–response studies. Finally, concerns over possible adverse events and the possibility of high attrition with a more rigorous program may also contribute to the lower prescribed volumes of physical activity. Although it was not the purpose of this article to track dose-related negative outcomes, this synthesis found that the frequency of falls or sprains among older adults enrolled in moderate-intensity RCTs was low. Future studies may also need to consider utilizing prescriptions that reflect the 2008 guidelines, for example, combining 3 days of moderate-intensity activity with 2 days of vigorous-intensity activity and prescribing higher durations of activity per occasion to determine negative outcomes. To date, there is little existing scientific evidence to determine whether health benefits of 30 min on 5 days a week are any different from the health benefits of 50 min on 3 days a week. However, one 10-week study by Stiggelbout, Popkema, Hopman-Rock, de Greef, and van Mechelen (2004) that prescribed 35 min of light aerobic activity to older adults had different outcomes if performed once or twice a week. Another study, by Wadell, Henriksson-Larsen, Lundgren, and Sundelin (2005), also found reduced health benefits due to different lengths of training times (1 vs. 3 days a week). The increase in the number of RCTs since 1997 targeting cognitive function is suggestive of a positive trend, although more research studies that document the frequency, duration, intensity, and type of activity are needed to guide future public health recommendations for cognitive impairment. This study found that the average dose prescribed in RCTs with measured outcomes of cognitive function was less than the 150 min per week recommendation. The optimal training frequency for improving or maintaining cognitive health is not known (Robertson, Campbell, Gardner, & Devlin, 2002), although the 2008 guidelines suggest that regular physical activity reduces the risk for many adverse health outcomes such as depression and cognitive function (USDHHS, 2008). In a metaanalysis by Colcombe and Kramer (2003), aerobic fitness training of 30 min or less had little impact on cognitive function. This finding is congruent with the 2008 guidelines that are not focused on frequency (days per week), but they do state that the more activity individuals do, the more health benefits they gain. There is a need for more research measuring cognitive health outcomes, as the literature still remains controversial as to the quantification of the exact amount of physical activity needed for health benefits. Several limitations of this study should be considered. First, this article focused on the aerobic component of prescribed physical activity, and many studies do not adequately describe the types of activities with enough specificity to allow comparison. S104 The Gerontologist Vol. 49, No. S1, 2009 S105 316; 24 101; 12 53; 12 134; 24 43; 12 187; 48 Rejeski (2002) Stahle (1999) Tsai (2002) Van Gool (2005) Wadell (2005) Williams (1997) Group 1:2:5:6 Group 1:2 Group 1:2 Group 1:2:5:6 Group 1:2 Group 1:2 Group 1:4 Group 1:2:3 Group 1:4:6 Group 1:2:6 Group 1:2:4 Group 1:2 Group 1:2 Group 1:6 Group 1:2 Group 1:2 Group 1:6 Group 1:6 Group 1:2 Group 1:2:3 Group 1:2:5 Group 1:2 Types of exercise interventiona 3; 30 3; 50 3; 30 3; 30 3; 45 2; 35 3; 45 3; 40 3; 30 3; 45 3; 50 3; 25 3; 30 3; 40 3; 30 3; 30 3; 30 3; 60 20 visits or 2 days a week; 23 3; 45 3; 35 3; 60 Frequency (days per week); duration (minutes per occasion) SF-36 MC KQ SF-36 MC SF-36 MC SF-36 MC DASS GDS CES-D AIMS EFI CES-D SF-36 MC CES-D CES-D SF-36 MC GDS QLP QLP SF-12 MC GDS BDI GDS Cognitive health outcomeb Significant difference BG (p < .05); significant difference WG (p < .05) Significant difference BG (p < .05); significant difference WG (p < .05) No difference BG; significant difference WG (p < .05) Significant difference BG (p < .05); Significant difference WG (p < .05) No difference BG; no difference WG No difference BG; significant difference WG (p < .05) No difference BG; no difference WG Significant difference WG (p < .01) Significant difference BG (p < .05); no difference WG No difference BG; no difference WG Significant difference BG (p < .05); significant difference WG (p < .05) Significant difference BG (p < .05); significant difference WG (p < .05) No difference BG; significant difference WG (p < .05) No difference BG No difference WG Significant difference WG (p < .05) No difference BG; no difference WG Significant difference BG (p < .05) Significant difference WG (p < .04) Significant difference WG (p < .01) No difference BG; significant difference WG (p < .05) Significant difference BG (p < .05) Effect of aerobic exercise on cognitive health outcome (between groups [BG] and within groups [WG]) b Notes: aTypes of exercise interventions: (1) aerobic; (2) control; (3) strength (or resistance) exercise; (4) flexibility exercise; (5) diet; and (6) others. Cognitive health measure: GDS = Geriatric Depression Scale; BDI = Beck Depression Inventory; CES-D = Center for Epidemiological Studies–Depression scale; SF-36 MC = 36-item Short Form, mental health component; QLP = quality-of-life parameters, mental health; SF-12 MC = 12-item Short Form, mental health component; EFI = Exercise-Induced Feeling Inventory, positive engagement; AIMS = Arthritis Impact Measurement Scale, depression component; KQ = Karolinska Questionnaire, depression; DASS = Depression Anxiety Stress Scale. 174; 24 438; 12 Motl (2005) Penninx (2002) 55; 12 Matsouka (2005) 120; 12 101; 16 31; 12 48; 12 40; 12 64; 24 32; 12 52; 12 283; 12 108; 16 33; 12 Blumenthal (1991) Collins (2004) Emery (1990) Etnier (2001) Gardner (2005) Gary (2004) Lavie (1997) Lavie (1996) Li (2005) Mangione (2005) Minor (1989) 134; 16 46; 24 N; duration (weeks) Blumenthal (2005) Antunes (2005) First author (year) Table 3. Summary of Moderate-Intensity Physical Activity Intervention Studies With Cognitive Health Outcomes A proportion of the studies were multicomponent (i.e., included strength training, flexibility, and balance components); thus, it is possible that the focus on the volume of aerobic activity may have underestimated the amount of physical activity performed by older adults. Second, it was not possible to account for the fact that participants in exercise trials begin at a lower dose and gradually increase it, until they reach the prescribed level. Third, information on the adherence rate to the prescribed volume or on the number or percentage of participants who completed each trial was not synthesized in this study. However, Hong and coworkers (2008) analyzed findings from the EBEOA database and found that group-based exercisers had higher attendance rates than those who exercised individually. Fourth, some studies included in this synthesis occurred before the development of physical activity recommendations. Finally, not all RCTs provided basic demographic characteristics such as sex, age range, race/ethnicity, or education, which limits our ability to make reference to specific groups of older adults. In summary, this article provides an overview of the gap between the number of published studies prescribing aerobic-based physical activity and the recommended guidelines for physical activity and public health. Based on the findings of this investigation, relatively few studies prescribed 150 min or more per week of moderate-intensity physical activity, including those studies that measure cognitive function outcomes. These gaps relate to the ability of the literature to inform public health recommendations and characterize the benefits of higher volumes of physical activity. 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