Months P h y s F u n c t i o n Score

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]