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Life 2: Improving Fitness and Function in Elders

Life 2: Improving Fitness and Function in Elders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00435188
Acronym
Project LIFE
Enrollment
400
Registered
2007-02-14
Start date
2004-11-30
Completion date
2008-04-30
Last updated
2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Mobility Limitations

Keywords

Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care, Randomized Clinical Trial, Veterans

Brief summary

The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.

Detailed description

Physical inactivity contributes greatly to the health care burden of older adults and is associated with a high prevalence of functional limitations, morbidity, and disability. Rates of physical inactivity are highest among older adults. Older veterans, compared non-veteran older adults, are more likely to be physically inactive and report more limitations in physical function. Increasing physical activity among older veterans is a promising approach to reduce the burden of chronic disease and its associated functional limitations. The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans The primary physical performance outcome is change in gait speed. Secondary objectives include examination of the effect of intervention between the two groups (intervention and usual care) on physical activity, self-reported physical function, and health-related quality of life. We also will estimate health care costs between the two groups to determine the short-term economic impact of the counseling in the VHA. Design. Randomized controlled clinical trial. Data collection. All consented patients will receive a baseline computer assisted interview and physical performance test to be repeated quarterly for one-year. The primary outcome is change in gait speed, which is highly predictive of subsequent institutionalization and mortality. Secondary outcome measures include: the SF-36 physical function and other relevant subscales, health-related quality of life, physical activity, self-efficacy, and personal functional goals. Differences between groups for non-routine outpatient clinic use and hospitalization will be explored. The cost of providing an intensive intervention (relative to the cost of usual care) will be calculated relative to functional changes between groups. Individuals randomized to the intervention group will receive a physical activity counseling intervention that includes four components. We will measure and assess change at each endpoint (3,6,9, 12, and 24 months) to determine short and long-term efficacy. Secondary analyses will include: (a) effect of intervention on self-reported physical function, physical activity, personal functional goals, and self-efficacy, and (b) comparison of outpatient clinic use and hospitalization costs between treatment arms relative to intervention costs. Duration Four years. Relevance to the VA. Because approximately 50% of veterans over age 74 have a limiting disability, it is imperative to explore strategies that will alter the course of functional decline of our aging veterans.

Interventions

BEHAVIORALMulti-component physical activity counseling program

A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 70 or over * Followed in VA primary care or geriatrics clinic * Currently not regularly physically active * Able to walk 10 meters without human assistance (assistive device acceptable)

Exclusion criteria

* Age 70 or over * Followed in VA primary care or geriatrics clinic * Currently not regularly physically active * Able to walk 10 meters without human assistance (assistive device acceptable) * A terminal diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Usual Gait SpeedBaselineBest of two trials over 8-foot walk
Rapid Gait SpeedBaseline

Secondary

MeasureTime frameDescription
Physical Activity Frequency (CHAMPS Questionnaire)BaselineExercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities
Self Rated HealthBaselineSelf-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Sf-36 Physical Function SubscaleBaselineThis is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.
2 Minute WalkBaselineDistance walked in two minutes in meters

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
199
Arm 2
Usual care
199
Total398

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath16
Overall StudyLost to Follow-up56
Overall StudyWithdrawal by Subject1611

Baseline characteristics

CharacteristicArm 2Arm 1Total
Age, Continuous77.4 years
STANDARD_DEVIATION 4.9
77.7 years
STANDARD_DEVIATION 5
77.5 years
STANDARD_DEVIATION 5
Assistive device
Participants reporting assistive device use
39 participants40 participants79 participants
Assistive device
Participants reporting no use of assistive devices
160 participants159 participants319 participants
Body mass index29.1 kg/m2
STANDARD_DEVIATION 4.6
28.9 kg/m2
STANDARD_DEVIATION 4.7
29 kg/m2
STANDARD_DEVIATION 4.6
Education
College graduate
55 participants52 participants107 participants
Education
Less or equal to high school
92 participants91 participants183 participants
Education
Some college or trade school
52 participants56 participants108 participants
Health quality of life of excellent or very good
Health QOL rated as Excellent or Very Good
76 participants71 participants147 participants
Health quality of life of excellent or very good
Health QOL rated as Good, Fair, or Poor
123 participants128 participants251 participants
Number of diseases5.5 Diseases
STANDARD_DEVIATION 2.7
5.2 Diseases
STANDARD_DEVIATION 2.5
5.3 Diseases
STANDARD_DEVIATION 2.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
42 Participants48 Participants90 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
157 Participants151 Participants308 Participants
Region of Enrollment
United States
199 participants199 participants398 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
199 Participants199 Participants398 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 1990 / 199
serious
Total, serious adverse events
0 / 1990 / 199

Outcome results

Primary

Rapid Gait Speed

Time frame: 3-month

ArmMeasureValue (MEAN)Dispersion
Arm 1Rapid Gait Speed1.62 meters/secondStandard Deviation 0.5
Arm 2Rapid Gait Speed1.58 meters/secondStandard Deviation 0.42
Primary

Rapid Gait Speed

Time frame: 12-month

ArmMeasureValue (MEAN)Dispersion
Arm 1Rapid Gait Speed1.68 meters/secondStandard Deviation 0.44
Arm 2Rapid Gait Speed1.59 meters/secondStandard Deviation 0.42
Comparison: Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedomp-value: 0.04Mixed Models Analysis
Primary

Rapid Gait Speed

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Arm 1Rapid Gait Speed1.56 meters/secondStandard Deviation 0.41
Arm 2Rapid Gait Speed1.57 meters/secondStandard Deviation 0.4
Primary

Usual Gait Speed

Best of two trials over 8-foot walk

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Arm 1Usual Gait Speed1.03 meters/secondStandard Deviation 0.25
Arm 2Usual Gait Speed1.03 meters/secondStandard Deviation 0.24
Primary

Usual Gait Speed

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Arm 1Usual Gait Speed1.09 meters/secondStandard Deviation 0.29
Arm 2Usual Gait Speed1.07 meters/secondStandard Deviation 0.28
Primary

Usual Gait Speed

Time frame: 12-month

ArmMeasureValue (MEAN)Dispersion
Arm 1Usual Gait Speed1.15 meters/secondStandard Deviation 0.28
Arm 2Usual Gait Speed1.12 meters/secondStandard Deviation 0.25
Comparison: Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedomp-value: 0.47Mixed Models Analysis
Secondary

2 Minute Walk

Distance walked in two minutes in meters

Time frame: 12 month

ArmMeasureValue (MEAN)Dispersion
Arm 12 Minute Walk150.9 metersStandard Deviation 38.5
Arm 22 Minute Walk147.5 metersStandard Deviation 34.7
Comparison: P value provides the overall differences between groups at the end of the studyp-value: 0.08Mixed Models Analysis
Secondary

2 Minute Walk

Distance walked in two minutes in meters

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Arm 12 Minute Walk146 metersStandard Deviation 36.3
Arm 22 Minute Walk145.4 metersStandard Deviation 32.8
Secondary

2 Minute Walk

Distance walked in two minutes in meters

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Arm 12 Minute Walk151.7 metersStandard Deviation 37.8
Arm 22 Minute Walk145.6 metersStandard Deviation 34.9
Secondary

Physical Activity Frequency (CHAMPS Questionnaire)

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Time frame: 12 month

ArmMeasureValue (MEAN)Dispersion
Arm 1Physical Activity Frequency (CHAMPS Questionnaire)22.4 times per weekStandard Deviation 12
Arm 2Physical Activity Frequency (CHAMPS Questionnaire)16.8 times per weekStandard Deviation 9.2
Comparison: Omnibus P value provides the overall differences between groups at the end of the studyp-value: <0.001Mixed Models Analysis
Secondary

Physical Activity Frequency (CHAMPS Questionnaire)

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Arm 1Physical Activity Frequency (CHAMPS Questionnaire)22.7 times per weekStandard Deviation 9.8
Arm 2Physical Activity Frequency (CHAMPS Questionnaire)17.6 times per weekStandard Deviation 9.4
Secondary

Physical Activity Frequency (CHAMPS Questionnaire)

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Arm 1Physical Activity Frequency (CHAMPS Questionnaire)15.9 times per weekStandard Deviation 9.4
Arm 2Physical Activity Frequency (CHAMPS Questionnaire)16.8 times per weekStandard Deviation 9.8
p-value: <0.001Mixed Models Analysis
Secondary

Self Rated Health

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Arm 1Self Rated HealthOverall health is excellent or very good71 participants
Arm 1Self Rated HealthOverall health is good, fair or poor128 participants
Arm 2Self Rated HealthOverall health is excellent or very good76 participants
Arm 2Self Rated HealthOverall health is good, fair or poor123 participants
Secondary

Self Rated Health

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Time frame: 3 month

ArmMeasureGroupValue (NUMBER)
Arm 1Self Rated HealthOverall health is excellent or very good82 participants
Arm 1Self Rated HealthOverall health is good, fair or poor102 participants
Arm 2Self Rated HealthOverall health is excellent or very good75 participants
Arm 2Self Rated HealthOverall health is good, fair or poor114 participants
Secondary

Self Rated Health

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Time frame: 12 month

ArmMeasureGroupValue (NUMBER)
Arm 1Self Rated HealthOverall health is excellent or very good78 participants
Arm 1Self Rated HealthOverall health is good, fair or poor100 participants
Arm 2Self Rated HealthOverall health is excellent or very good70 participants
Arm 2Self Rated HealthOverall health is good, fair or poor107 participants
Comparison: Omnibus P value provides the overall difference between groups at the end of the studyp-value: 0.29Mixed Models Analysis
Secondary

Sf-36 Physical Function Subscale

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Time frame: 12 month

ArmMeasureValue (MEAN)Dispersion
Arm 1Sf-36 Physical Function Subscale69.9 units on a scaleStandard Deviation 22.1
Arm 2Sf-36 Physical Function Subscale62.7 units on a scaleStandard Deviation 23.8
Comparison: P value provides overall differences between groups at the end of the studyp-value: 0.35Mixed Models Analysis
Secondary

Sf-36 Physical Function Subscale

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Time frame: 3 month

ArmMeasureValue (MEAN)Dispersion
Arm 1Sf-36 Physical Function Subscale70 units on a scaleStandard Deviation 22.4
Arm 2Sf-36 Physical Function Subscale63.1 units on a scaleStandard Deviation 24
Secondary

Sf-36 Physical Function Subscale

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Arm 1Sf-36 Physical Function Subscale68 units on a scaleStandard Deviation 22.2
Arm 2Sf-36 Physical Function Subscale62.9 units on a scaleStandard Deviation 23.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026