Physical activity to maintain independence in older adults Marco Pahor, MD University of Florida Institute on Aging www.aging.ufl.edu Background • One of major goals of geriatric medicine: the prevention and management of disability in older persons • Major limitation of geriatric medicine: no definitive Phase 3 RCT has proven that an intervention can prevent or delay the onset of major physical disability, such as mobility disability, in initially non-disabled older persons Exercise and Disability (FAST) Adjusted % change in disability score 15% Control 10% 5% Resistance exercise P<.001 vs. control Aerobic exercise 0% -5% -10% 0 3 9 Follow up (months) 18 Ettinger et al. JAMA 1997 Probability % FAST Physical exercise and ADL disability 70 60 50 40 30 20 10 0 Control Resistance Aerobic P<.001 vs. control 0 3 6 9 12 15 18 Months Penninx et al. Arch Intern Med 2001 ADAPT Physical Disability Summary Disability Score 2.05 2.00 Healthy Lifestyle Control 1.95 1.90 Exercise 1.85 Diet 1.80 1.75 Diet + Exercise * 1.70 0 6 12 18 Time (months) Messier et al. Arthritis and Rheumatism 2004;50:1501 Efficacy of physical activity interventions Extensive evidence from RCTs of limited size and duration and observational studies on the benefits of physical activity on several physiological measures: • Walking speed, balance • Muscle strength • Body composition • Biomarkers A Phase 3 RCT is needed • Limited data on clinically relevant disability/mobility outcomes • The observational evidence is not sufficient (reverse causality) • Need for good risk / benefit data in older persons at high risk of disability LIFE-P Major goals Refine key trial design benchmarks: • Primary outcome of major mobility disability (inability to walk 400 m) • Sample size calculations • Recruitment, retention • Interventions: feasibility, safety & adherence • Internal validity: effects on the SPPB score and the 400 m walk speed • Secondary outcomes: ADL, major falls, CVD, cognition, HRQL, health care services, CEA • Organizational infrastructure Background and objective • A low SPPB score independently predicts mobility disability and ADL disability • There is no definitive evidence from RCTs that changes in SPPB scores can be modified • Objective: to assess the effect of a comprehensive physical activity (PA) intervention on the SPPB score and other physical performance measures J Gerontol Biol Sci Med Sci 2006;61:1157 LIFE-P Inclusion criteria • 70-89 years • Sedentary lifestyle • Able to walk 400 m • SPPB score <9 • Completed a behavioral run-in • Gives informed consent, lives in study area Exclusion criteria • Medical conditions that raise concerns regarding safety or adherence to a physical activity program 3,141 telephone 1,889 excluded of which 539 refused 1,252 SPPB 686 excluded of which 168 refused 566 medical & 400 m walk 424 randomized 142 excluded of which 14 refused 213 physical activity 211 successful aging 2 deceased; 3 withdrawals 204 available for SPPB analysis at 12 mo 2 deceased; 6 withdrawals 193 available for SPPB analysis at 12 mo J Gerontol Biol Sci Med Sci 2006;61:1157 Successful aging intervention • Organized health workshops relevant to older adults (e.g., healthful nutrition, how to effectively negotiate the health care system, how to travel safely, etc.) • Short instructor-led program (5-10 min) of upper extremity stretching exercises • Group meeting once per week for weeks 1 - 24 and once per month for weeks 25 through the end of the study Physical activity intervention Center-based in a group setting with a systematic transition to home-based exercise • Aerobic (walking) • Strength (lower extremities) • Balance • Flexibility stretching • Behavioral counseling (group and telephone) LIFE-P SPPB score 10 8.7 Score 9 8.5 P<0.001 8 8.0 7.5 7 7.9 Physical activity Successful aging 6 0 6 mo 12 mo Means estimated from repeated measures ANCOVA adjusted for gender, field center and baseline values J Gerontol Biol Sci Med Sci 2006;61:1157 Theoretical clinical relevance of SPPB score • HRQL • 0.5 points= small meaningful change • 1.0 points= substantial meaningful change • Disability outcomes over 4 years 1 point = approximately 30% excess risk of ADL or mobility disability Perera et al. JAGS 2006;54:743 Guralnik et al. J Gerontol Med Sci 2000;55:M221 Percent of participants who improved by >1 point, did not change, or declined by >1 point in the SPPB score from baseline to 6 and 12 mos. 100% 6 month P=0.004 80% 12 month P=0.03 SPPB change vs. baseline 102 100 128 133 60% 40% 20% 33 44 34 31 35 56 60 42 0% PA SA PA Improve >=1 point No change Decline >=1 point SA NNT for improvement = 6 at 6 mos and 9 at 12 mos NNT for preventing decline = 10 at 6 and 12 mos J Gerontol Biol Sci Med Sci 2006;61:1157 SPPB change distribution for SPPB change distribution Global Change Rating Worse (somewhat + much, n=104) Mean 0.21, SD 2.32 GRS About the same (n=155) Mean 0.73, SD 1.91 Better (somewhat + much, n=123) Mean 1.22, SD 1.74 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 SPPB change Plot 1 Boxplot indicates median, inter quartile ranges (25th and 75th) , 5th and 95th percentiles. Blue line indicates mean value. LIFE-P 400 m walk speed m/sec 1 0.9 0.87 0.85 P<0.001 0.86 0.84 0.8 0.82 Physical activity Successful aging 0.7 0 6 mo 12 mo Means estimated from repeated measures ANCOVA adjusted for gender, field center and baseline values J Gerontol Biol Sci Med Sci 2006;61:1157 Gait speed change* distribution gait speed change distribution for Global Change Rating Worse (somewhat + much, n=84) Mean -0.05, SD 0.11 GRS About the same (n=146) Mean -0.006, SD 0.11 Better (somewhat + much, n=115) Mean 0.01, SD 0.14 * Gait speed change among who completed 400m walk. -0.3 -0.2 -0.1 0.0 0.1 0.2 0.3 gait speed change (m/s) Plot 1 Boxplot indicates median, inter quartile ranges (25th and 75th) , 5th and 95th percentiles. Blue line indicates mean value. Conclusions • Compared to SA, PA improved the SPPB score and 400 m walk speed • Consistency among major subgroups • Minimal loss to follow-up • Excellent safety record • An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes, such as mobility disability Cumulative hazard of time until major mobility disability Number at risk SA PA 211 213 210 213 191 191 107 125 24 33 Cumulative SA endpoints PA 0 0 13 15 28 23 33 24 34 26 LIFE main study Field Centers CA PA IL CO MA CT IN NC LA N = 2,000 FL - average FU = 4.5 yrs LIFE Main study • Will have important implications for public health prevention • Will fill a critical gap in knowledge for practicing evidence-based geriatric medicine • Will provide evidence regarding a broad spectrum of relevant health outcomes • Will impact clinical practice and public health policy • Will benefit individuals and society Implementation of Physical Activity Interventions to Improve Physical Function In Elders Part 2 The Durham VA GRECC Gerofit Program Facility-based exercise and health promotion program established in 1986 as a GRECC clinical demonstration project. Developed in response to Veterans Health Care Amendment of 1983 mandating implementation of preventive medicine in VA’s. Fitness programming identified as a targeted area of need. Individually tailored to meet needs of older veterans with chronic conditions and physical impairments, many as a result of military service. Veterans ages 65 and over have access to facilitybased supervised exercise program (treadmills, stationary bicycles, stair machine, weight training machines, floor exercises, tai chi, water aerobics) -Over 1200 patients referred -Average daily census + 60 patients Referred by primary care providers and other health care specialists Special consultative services available as needed Telephone counseling offered to: -Patients who live too far to attend the facilitybased program - Patients under age 65 Key published clinical outcomes Veterans participating in Gerofit report significant improvements in exercise capacity, cardiovascular risk factors and psychological well-being. JAGS (37):1989; J Appl Ger (10):1991. Examination of impact of burden of disease (no disease vs. 1 disease vs. 2 diseases) on exercise parameters and 5year trajectories of performance. JAGS (44):1996. Older veterans with chronic diseases experience a longterm beneficial mortality effect from participation in facilitybased program. JAGS (50):2002. Older veterans enrolling in Gerofit have significantly poorer physical performance than national normative data. And, veterans participating in Gerofit for 6 months or more have physical performance on par or higher than reported national norms. JRRD (41):2004. Transition to Funded Research Aerobic vs. Axial/Aerobic Training: Improvement in Function (PI: Morey, 1992-1995) (facility to home-based) Phoning for Function: Promoting Health After Cancer (PI: Demark, 1997-2003) (home-based) Improving Fitness and Function in Elders (LIFE 1) (PI: Morey, 2001-2004) (home-based) Learning to Improve Fitness and Function in Elders (LIFE 2) (PI: Morey, 2004-2008) (home-based) RENEW: Reach Out to Enhance Wellness in Older Survivors (PI Demark 2004-2008) (home-based) Aerobic vs. Axial/Aerobic Training: Improvement in Function (facility to home-based) Randomized clinical trial •Three months of supervised exercise • Followed by six months of home-based exercise with telephone follow-up Intervention (3 days per week) • Axial/Aerobic group 20 minutes axial mobility exercises 20 minutes aerobic exercise • Aerobic group 40 minutes aerobic exercise Change in Aerobic Capacity 20.5 V O 20 2 19.5 Axial/ Aerobic P 19 e 18.5 a k 18 Aerobic 17.5 17 ml/kg/min 0 3 9 Months Findings: Significant overall improvement, both groups, p=0.0001 0-3 mos. group*time interaction, p=0.0014 (dose response) 0-9 mos: p=0.07 Morey et al., J Geron Med Sci 1999 54A M335-M342. Change in Physical Function P h y s F u n c t i o n Score 85 83 81 79 77 75 73 71 69 67 65 Axial/ Aerobic Aerobic 0 3 9 Months Morey et al., J Geron Med Sci 1999 54A M335-M342. Findings: Significant overall improvement, both groups, p=0.0016 0-3 mos. p=0.004 0-9 mos. p=0.68 No between group differences Secondary Improvements • • • Health Related Quality of Life, p= 0.0009 Total Number of Symptoms Reported, p=0.0001 Effect of Symptoms on Functional Limitations, p=0.0001 Morey et al., J Geron Med Sci 1999 54A M335-M342. What did we learn and where do we go from here? Facility-based have more robust outcomes; but most people choose homebased exercise How can we successfully apply these approaches to home-based intervention? How can we assess/ enhance adherence? Predictors of adherence Number of diseases Body mass index Physical function Pain **Weekend adherence 90 80 Percent Adherent 70 60 50 Adherents Non adherents 40 30 20 10 0 1 3 5 7 9 11 13 15 17 19 21 23 25 Weeks Morey, et al. J Aging Phys Act 2003, 11,351-368 Functional Outcomes by Level of Adherence: SF-36 Physical Function 100 95 90 F u 85 n 80 c 75 t 70 i 65 o 60 n 55 50 Adherent Non-Adh Findings: Change in physical function scores between 3 and 9 months differed by level of adherence. (Chi sq. = 5.67, 1 df, p= 0.017) Adherents maintained gains Non adherents declined to baseline functional score. 0 3 Months 9 Project LIFE 1 And 2 Use state of the art counseling methods to enhance adherence Desire to include primary care providers as part of counseling team Needed to involve more functionally limited elders Project Life 1 Six-month feasibility trial Primary care providers endorsed PA one-time in clinic Health counselor gave baseline PA counseling to everyone prior to randomization High intensity group had 3 months bi-weekly PA counseling and 3 months monthly PA counseling More frequent telephone contact was needed High Intensity 20 15 Attention Control 10 Usual Care 5 0 6 month Patients valued primary care provider involvement 25 3 month One-time counseling had short-term benefit that was not sustained Baseline Physical Activity Frequency Project LIFE 1 Morey, et al. J Aging Phys Act 2006 14 324-343 Project LIFE 2 12-month multi component PA trial comparing counseling to usual care • • • • One-time in person Provider endorsement Sustained telephone counseling Sustained provider endorsement by automated telephone messaging • Mailed quarterly progress report Goal: 30 min 5 days/week aerobic 15 min strength training 3 days/wk Project LIFE 2 Counseling must be sustained It takes one year to get close to recommended PA guidelines Provider involvement is highly acceptable These changes are accompanied by improvements in physical function Minutes of self reported exercise per week Reported minutes per week 150 Counsel 100 UC 50 0 0 3 6 Months 12 From Physical Activity to Physical Function Physical Function Subscale SF-36 Change in Physical Function by Change in Physical Activity Over Time (raw means + s.e.) 70 65 60 55 50 45 40 35 30 >150 min/wk PA to < 150 min/wk P o o < 150 l min/wk PA to e > 150 min/wk d d Baseline 6 months a t a In an adjusted model, change in PA from < 150 min/wk to f ≥ 150 min/wk or from ≥ 150 min/wk to < 150 min/wk r resulted in a significant difference in PF (+ 6.4 points, o p=0.006) controlling for age, race, gender, and baseline mPA , baseline PF and trial. s Physical Activity to Physical Function Benefits are more easily achieved among adults of higher physical function Exercise modality is not crucial – any exercise is better than being sedentary Among more impaired adults and those with multiple morbidities results are more tenuous Summary Change in physical function, physical performance is variable • Population under study • Intensity of intervention • Specificity of training Measures sensitive to change • • • • Physical Function Subscale Sickness Impact Profile Gait Speed Endurance walk Conclusions Physical activity interventions of diverse content can be implemented across multiple settings Adherence to physical activity can be easily identified Methods to address non-adherence need further study For questions relative to this presentation please contact Miriam Morey at [email protected]
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