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Physical activity to maintain independence in older adults Marco Pahor, MD University of Florida 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 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 Control Resistance exercise P<. Exercise and Disability (FAST) Adjusted % change in disability score Control Resistance exercise P<. 001 vs. control Aerobic exercise 0 3 9 Follow up (months) 18 Ettinger et al. JAMA 1997

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

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

Efficacy of physical activity interventions Extensive evidence from RCTs of limited size and duration 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 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 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 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 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 3, 141 telephone 1, 889 excluded of which 539 refused 1, 252 SPPB 686 excluded 566 medical & 400 m walk 424 randomized of which 168 refused 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. , 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 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 P<0. 001 mo mo Means estimated from repeated measures ANCOVA adjusted LIFE-P SPPB score P<0. 001 mo 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 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: M 221

Percent of participants who improved by >1 point, did not change, or declined by 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. 6 month P=0. 004 12 month P=0. 03 SPPB change vs. baseline 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 Global Change Rating Worse (somewhat + much, n=104) Mean 0. SPPB change distribution for Global Change Rating 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.

LIFE-P 400 m walk speed P<0. 001 mo mo Means estimated from repeated measures LIFE-P 400 m walk speed P<0. 001 mo 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 for Global Change Rating Worse (somewhat + much, n=84) Mean Gait speed change* distribution for Global Change Rating 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 * Gait speed change among who completed 400 m walk. Boxplot indicates median, inter quartile ranges (25 th and 75 th) , 5 th and 95 th percentiles. Blue line indicates mean value.

Conclusions • Compared to SA, PA improved the SPPB score and 400 m walk 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 Cumulative hazard of time until major mobility disability Number at risk SA PA 211 213 210 213 191 107 125 24 33 Cumulative SA endpoints PA 0 0 13 15 28 23 33 24 34 26

LIFE main study Field Centers CA IL CO PA MA CT IN NC LA LIFE main study Field Centers CA IL CO PA 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 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 Implementation of Physical Activity Interventions to Improve Physical Function In Elders Part 2 The Durham VA GRECC

Gerofit Program n n n Facility-based exercise and health promotion program established in 1986 Gerofit Program n n n 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 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 facility based program - Patients under age 65

Key published clinical outcomes n n Veterans participating in Gerofit report significant improvements in Key published clinical outcomes n n 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. 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 n Aerobic vs. Axial/Aerobic Training: Improvement in Function (PI: Morey, Transition to Funded Research n Aerobic vs. Axial/Aerobic Training: Improvement in Function (PI: Morey, 1992 -1995) (facility to home-based) n Phoning for Function: Promoting Health After Cancer (PI: Demark, 1997 -2003) (home-based) n Improving Fitness and Function in Elders (LIFE 1) (PI: Morey, 2001 -2004) (home-based) n Learning to Improve Fitness and Function in Elders (LIFE 2) (PI: Morey, 2004 -2008) (home-based) n 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 • 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 Findings: Significant overall improvement, both groups, p=0. 0001 V O Change in Aerobic Capacity Findings: Significant overall improvement, both groups, p=0. 0001 V O 2 P e a k ml/kg/min Months 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 54 A M 335 -M 342.

Change in Physical Function P h y s Findings: Significant overall improvement, both groups, Change in Physical Function P h y s Findings: Significant overall improvement, both groups, p=0. 0016 F u n c t i o n Score Months Morey et al. , J Geron Med Sci 1999 54 A M 335 -M 342. 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 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 54 A M 335 -M 342.

What did we learn and where do we go from here? n n n What did we learn and where do we go from here? n n n 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 n n n Number of diseases Body mass index Physical function Predictors of adherence n n n Number of diseases Body mass index Physical function Pain **Weekend adherence Weeks Morey, et al. J Aging Phys Act 2003, 11, 351 -368

Functional Outcomes by Level of Adherence: SF-36 Physical Function Findings: Change in physical function 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 F u n c t i o n Non adherents declined to baseline functional score. Months

Project LIFE 1 And 2 n n n Use state of the art counseling Project LIFE 1 And 2 n n n 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 n n Six-month feasibility trial Primary care providers endorsed PA one-time Project Life 1 n n 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

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

Project LIFE 2 n 12 -month multi component PA trial comparing counseling to usual Project LIFE 2 n 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 n

Project LIFE 2 n n Counseling must be sustained It takes one year to Project LIFE 2 n n 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

From Physical Activity to Physical Function >150 min/wk PA to < 150 min/wk P From Physical Activity to Physical Function >150 min/wk PA to < 150 min/wk P o o < 150 l min/wk PA to e > 150 min/wk d d 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 m. PA , baseline PF and trial. s

Physical Activity to Physical Function n Benefits are more easily achieved among adults of Physical Activity to Physical Function n 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 n Change in physical function, physical performance is variable • Population under study Summary n Change in physical function, physical performance is variable • Population under study • Intensity of intervention • Specificity of training n Measures sensitive to change • • Physical Function Subscale Sickness Impact Profile Gait Speed Endurance walk

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