1. Physical activity to maintain independence in older adults Marco Pahor, MD University of Florida Institute on Aging www.aging.ufl.edu

2. 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 Background

3. Adjusted % change in disability score Ettinger et al. JAMA 1997 Control Resistance exercise Aerobic exercise Follow up (months) 01893 Exercise and Disability (FAST) P<.001 vs. control

4. FAST Physical exercise and ADL disability Penninx et al. Arch Intern Med 2001 P<.001 vs. control

5. ADAPT Messier et al. Arthritis and Rheumatism 2004;50:1501

6. 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 Efficacy of physical activity interventions

7. 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

8. 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 LIFE-P Major goals

9. 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 Background and objective J Gerontol Biol Sci Med Sci 2006;61:1157

10. 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 LIFE-P

11. 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 213 physical activity 211 successful aging 142 excluded of which 14 refused 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

12. 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

13. 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)

14. P<0.001 mo Means estimated from repeated measures ANCOVA adjusted for gender, field center and baseline values LIFE-P SPPB score J Gerontol Biol Sci Med Sci 2006;61:1157

15. 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 Theoretical clinical relevance of SPPB score Perera et al. JAGS 2006;54:743 Guralnik et al. J Gerontol Med Sci 2000;55:M221

16. SPPB change vs. baseline 6 month P=0.004 12 month P=0.03 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. 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

17. Worse (somewhat + much, n=104) Mean 0.21, SD 2.32 About the same (n=155) Mean 0.73, SD 1.91 Better (somewhat + much, n=123) Mean 1.22, SD 1.74 Boxplot indicates median, inter quartile ranges (25 th and 75 th ), 5 th and 95 th percentiles. Blue line indicates mean value. SPPB change distribution for Global Change Rating

18. P<0.001 mo Means estimated from repeated measures ANCOVA adjusted for gender, field center and baseline values LIFE-P 400 m walk speed J Gerontol Biol Sci Med Sci 2006;61:1157

19. Worse (somewhat + much, n=84) Mean -0.05, SD 0.11 About the same (n=146) Mean -0.006, SD 0.11 Better (somewhat + much, n=115) Mean 0.01, SD 0.14 Boxplot indicates median, inter quartile ranges (25 th and 75 th ), 5 th and 95 th percentiles. Blue line indicates mean value. Gait speed change* distribution for Global Change Rating * Gait speed change among who completed 400m walk.

20. Compared to SA, PA improved the SPPB score and 400 m walk speed C onsistency 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 Conclusions

21. Cumulative hazard of time until major mobility disability SA 211 PA 213 Number at risk 210 213 191 107 125 24 33 SA 0 PA 0 Cumulative endpoints 13 15 28 23 33 24 34 26

22. LIFE main study Field Centers CA CO LA FL IL IN NC PA CT MA N = 2,000 - average FU = 4.5 yrs

23. 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 LIFE Main study

24. Implementation of Physical Activity Interventions to Improve Physical Function In Elders Part 2 The Durham VA GRECC

25. Gerofit Program Facility-based exercise and health promotion program established in 1986 as a GRECC clinical demonstration project. 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. 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. Individually tailored to meet needs of older veterans with chronic conditions and physical impairments, many as a result of military service.

26. Veterans ages 65 and over have access to facility- based 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 facility- based program - Patients under age 65

27. 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. 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 5- year trajectories of performance. JAGS (44):1996. Examination of impact of burden of disease (no disease vs. 1 disease vs. 2 diseases) on exercise parameters and 5- year trajectories of performance. JAGS (44):1996. Older veterans with chronic diseases experience a long- term beneficial mortality effect from participation in facility- based program. JAGS (50):2002. Older veterans with chronic diseases experience a long- term beneficial mortality effect from participation in facility- based 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. 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.

28. Transition to Funded Research Aerobic vs. Axial/Aerobic Training: Improvement in Function (PI: Morey, 1992-1995) (facility to home-based) 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) 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) 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) 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) RENEW: Reach Out to Enhance Wellness in Older Survivors (PI Demark 2004-2008) (home-based)

29. Aerobic vs. Axial/Aerobic Training: Improvement in Function (facility to home-based) Randomized clinical trial Three months of supervised exerciseThree months of supervised exercise Followed by six months of home-based exercise Followed by six months of home-based exercise with telephone follow-up with telephone follow-up Intervention (3 days per week) Axial/Aerobic group Axial/Aerobic group 20 minutes axial mobility exercises 20 minutes axial mobility exercises 20 minutes aerobic exercise 20 minutes aerobic exercise Aerobic group Aerobic group 40 minutes aerobic exercise 40 minutes aerobic exercise

30. Change in Aerobic Capacity Findings: Significant overall improvement, both groups, p=0.0001 both groups, p=0.0001 0-3 mos. group*time interaction, p=0.0014 group*time interaction, p=0.0014 (dose response) 0-9 mos: p=0.07 Months VO 2 Pea k ml/kg/min Morey et al., J Geron Med Sci 1999 54A M335-M342.

31. Change in Physical Function Findings: Significant overall improvement, both groups, p=0.0016 both groups, p=0.0016 0-3 mos. p=0.004 0-9 mos. p=0.68 No between group differences Months PhysFunction Score Morey et al., J Geron Med Sci 1999 54A M335-M342.

32. Secondary Improvements Health Related Quality of Life, p= 0.0009 Health Related Quality of Life, p= 0.0009 Total Number of Symptoms Reported, p=0.0001 Total Number of Symptoms Reported, p=0.0001 Effect of Symptoms on Functional Limitations, p=0.0001 Effect of Symptoms on Functional Limitations, p=0.0001 Morey et al., J Geron Med Sci 1999 54A M335-M342.

33. What did we learn and where do we go from here? Facility-based have more robust outcomes; but most people choose home- based exercise Facility-based have more robust outcomes; but most people choose home- based exercise How can we successfully apply these approaches to home-based intervention? How can we successfully apply these approaches to home-based intervention? How can we assess/ enhance adherence? How can we assess/ enhance adherence?

34. Predictors of adherence Number of diseases Number of diseases Body mass index Body mass index Physical function Physical function Pain Pain **Weekend adherence **Weekend adherence Weeks Morey, et al. J Aging Phys Act 2003, 11,351-368

35. Functional Outcomes by Level of Adherence: SF-36 Physical Function 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. Non adherents declined to baseline functional score. Months Function

36. Project LIFE 1 And 2 Use state of the art counseling methods to enhance adherence Use state of the art counseling methods to enhance adherence Desire to include primary care providers as part of counseling team Desire to include primary care providers as part of counseling team Needed to involve more functionally limited elders Needed to involve more functionally limited elders

37. Project Life 1 Six-month feasibility trial Six-month feasibility trial Primary care providers endorsed PA one-time in clinic Primary care providers endorsed PA one-time in clinic Health counselor gave baseline PA counseling to everyone prior to randomization 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 High intensity group had 3 months bi-weekly PA counseling and 3 months monthly PA counseling

38. Project LIFE 1 One-time counseling had short-term benefit that was not sustained One-time counseling had short-term benefit that was not sustained Patients valued primary care provider involvement Patients valued primary care provider involvement More frequent telephone contact was needed More frequent telephone contact was needed Morey, et al. J Aging Phys Act 2006 14 324-343

39. Project LIFE 2 12-month multi component PA trial comparing counseling to usual care 12-month multi component PA trial comparing counseling to usual care One-time in personOne-time in person Provider endorsementProvider endorsement Sustained telephone counselingSustained telephone counseling Sustained provider endorsement by automated telephone messagingSustained provider endorsement by automated telephone messaging Mailed quarterly progress reportMailed quarterly progress report Goal: 30 min 5 days/week aerobic Goal: 30 min 5 days/week aerobic 15 min strength training 3 days/wk 15 min strength training 3 days/wk

40. Project LIFE 2 Counseling must be sustained Counseling must be sustained It takes one year to get close to recommended PA guidelines It takes one year to get close to recommended PA guidelines Provider involvement is highly acceptable Provider involvement is highly acceptable These changes are accompanied by improvements in physical function These changes are accompanied by improvements in physical function

41. From Physical Activity to Physical Function Pooled data from several studiesPooled data from several studies >150 min/wk PA to < 150 min/wk 150 min/wk In an adjusted model, change in PA from < 150 min/wk to ≥ 150 min/wk or from ≥ 150 min/wk to < 150 min/wk resulted in a significant difference in PF (+ 6.4 points, p=0.006) controlling for age, race, gender, and baseline PA, baseline PF and trial.

42. Physical Activity to Physical Function Benefits are more easily achieved among adults of higher 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 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 Among more impaired adults and those with multiple morbidities results are more tenuous

43. Summary Change in physical function, physical performance is variable Change in physical function, physical performance is variable Population under studyPopulation under study Intensity of interventionIntensity of intervention Specificity of trainingSpecificity of training Measures sensitive to change Measures sensitive to change Physical Function SubscalePhysical Function Subscale Sickness Impact ProfileSickness Impact Profile Gait SpeedGait Speed Endurance walkEndurance walk

44. Conclusions Physical activity interventions of diverse content can be implemented across multiple settings Physical activity interventions of diverse content can be implemented across multiple settings Adherence to physical activity can be easily identified Adherence to physical activity can be easily identified Methods to address non-adherence need further study Methods to address non-adherence need further study For questions relative to this presentation please contact Miriam Morey at morey@geri.duke.edu