Aging, Mobility Limitations
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Usual Gait Speed | Baseline | Best of two trials over 8-foot walk |
| Rapid Gait Speed | Baseline | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Frequency (CHAMPS Questionnaire) | Baseline | Exercise 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 Health | Baseline | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good |
| Sf-36 Physical Function Subscale | Baseline | 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. |
| 2 Minute Walk | Baseline | Distance walked in two minutes in meters |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 6 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Withdrawal by Subject | 16 | 11 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Continuous | 77.4 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 participants | 40 participants | 79 participants |
| Assistive device Participants reporting no use of assistive devices | 160 participants | 159 participants | 319 participants |
| Body mass index | 29.1 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 participants | 52 participants | 107 participants |
| Education Less or equal to high school | 92 participants | 91 participants | 183 participants |
| Education Some college or trade school | 52 participants | 56 participants | 108 participants |
| Health quality of life of excellent or very good Health QOL rated as Excellent or Very Good | 76 participants | 71 participants | 147 participants |
| Health quality of life of excellent or very good Health QOL rated as Good, Fair, or Poor | 123 participants | 128 participants | 251 participants |
| Number of diseases | 5.5 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 48 Participants | 90 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 157 Participants | 151 Participants | 308 Participants |
| Region of Enrollment United States | 199 participants | 199 participants | 398 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 199 Participants | 199 Participants | 398 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 199 | 0 / 199 |
| serious Total, serious adverse events | 0 / 199 | 0 / 199 |
Outcome results
Rapid Gait Speed
Time frame: 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Rapid Gait Speed | 1.62 meters/second | Standard Deviation 0.5 |
| Arm 2 | Rapid Gait Speed | 1.58 meters/second | Standard Deviation 0.42 |
Rapid Gait Speed
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Rapid Gait Speed | 1.68 meters/second | Standard Deviation 0.44 |
| Arm 2 | Rapid Gait Speed | 1.59 meters/second | Standard Deviation 0.42 |
Rapid Gait Speed
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Rapid Gait Speed | 1.56 meters/second | Standard Deviation 0.41 |
| Arm 2 | Rapid Gait Speed | 1.57 meters/second | Standard Deviation 0.4 |
Usual Gait Speed
Best of two trials over 8-foot walk
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Usual Gait Speed | 1.03 meters/second | Standard Deviation 0.25 |
| Arm 2 | Usual Gait Speed | 1.03 meters/second | Standard Deviation 0.24 |
Usual Gait Speed
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Usual Gait Speed | 1.09 meters/second | Standard Deviation 0.29 |
| Arm 2 | Usual Gait Speed | 1.07 meters/second | Standard Deviation 0.28 |
Usual Gait Speed
Time frame: 12-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Usual Gait Speed | 1.15 meters/second | Standard Deviation 0.28 |
| Arm 2 | Usual Gait Speed | 1.12 meters/second | Standard Deviation 0.25 |
2 Minute Walk
Distance walked in two minutes in meters
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | 2 Minute Walk | 150.9 meters | Standard Deviation 38.5 |
| Arm 2 | 2 Minute Walk | 147.5 meters | Standard Deviation 34.7 |
2 Minute Walk
Distance walked in two minutes in meters
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | 2 Minute Walk | 146 meters | Standard Deviation 36.3 |
| Arm 2 | 2 Minute Walk | 145.4 meters | Standard Deviation 32.8 |
2 Minute Walk
Distance walked in two minutes in meters
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | 2 Minute Walk | 151.7 meters | Standard Deviation 37.8 |
| Arm 2 | 2 Minute Walk | 145.6 meters | Standard Deviation 34.9 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Physical Activity Frequency (CHAMPS Questionnaire) | 22.4 times per week | Standard Deviation 12 |
| Arm 2 | Physical Activity Frequency (CHAMPS Questionnaire) | 16.8 times per week | Standard Deviation 9.2 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Physical Activity Frequency (CHAMPS Questionnaire) | 22.7 times per week | Standard Deviation 9.8 |
| Arm 2 | Physical Activity Frequency (CHAMPS Questionnaire) | 17.6 times per week | Standard Deviation 9.4 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Physical Activity Frequency (CHAMPS Questionnaire) | 15.9 times per week | Standard Deviation 9.4 |
| Arm 2 | Physical Activity Frequency (CHAMPS Questionnaire) | 16.8 times per week | Standard Deviation 9.8 |
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Self Rated Health | Overall health is excellent or very good | 71 participants |
| Arm 1 | Self Rated Health | Overall health is good, fair or poor | 128 participants |
| Arm 2 | Self Rated Health | Overall health is excellent or very good | 76 participants |
| Arm 2 | Self Rated Health | Overall health is good, fair or poor | 123 participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Self Rated Health | Overall health is excellent or very good | 82 participants |
| Arm 1 | Self Rated Health | Overall health is good, fair or poor | 102 participants |
| Arm 2 | Self Rated Health | Overall health is excellent or very good | 75 participants |
| Arm 2 | Self Rated Health | Overall health is good, fair or poor | 114 participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 | Self Rated Health | Overall health is excellent or very good | 78 participants |
| Arm 1 | Self Rated Health | Overall health is good, fair or poor | 100 participants |
| Arm 2 | Self Rated Health | Overall health is excellent or very good | 70 participants |
| Arm 2 | Self Rated Health | Overall health is good, fair or poor | 107 participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Sf-36 Physical Function Subscale | 69.9 units on a scale | Standard Deviation 22.1 |
| Arm 2 | Sf-36 Physical Function Subscale | 62.7 units on a scale | Standard Deviation 23.8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Sf-36 Physical Function Subscale | 70 units on a scale | Standard Deviation 22.4 |
| Arm 2 | Sf-36 Physical Function Subscale | 63.1 units on a scale | Standard Deviation 24 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Sf-36 Physical Function Subscale | 68 units on a scale | Standard Deviation 22.2 |
| Arm 2 | Sf-36 Physical Function Subscale | 62.9 units on a scale | Standard Deviation 23.1 |