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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Behavioral: 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 visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback |
|
| Arm 2 | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component physical activity counseling program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usual Gait Speed | Best of two trials over 8-foot walk | Baseline |
| Usual Gait Speed | 3 month | |
| Usual Gait Speed | 12-month | |
| Rapid Gait Speed | Baseline | |
| Rapid Gait Speed | 3-month | |
| Rapid Gait Speed | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Physical Activity Frequency (CHAMPS Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam C. Morey, PhD | VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19117329 | Background | Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491. | |
| 19436015 |
| Label | URL |
|---|---|
| Website containing short physical activity counseling protocols developed for this study. Counseling protocols and physical assessment forms are based on the stage of change transtheoretical models and are modified for older adults. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1, Physical Activity Counseling | 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 visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback |
| FG001 | Arm 2, Usual Care | Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usual Gait Speed | Best of two trials over 8-foot walk | Posted | Mean | Standard Deviation | meters/second | Baseline |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1, Physical Activity Counseling | 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 visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miriam C. Morey, Ph.D. | Durham VA Research and Development | 919-286-0411 | 6776 | miriam.morey@va.gov |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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|
Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities |
| 3 month |
| 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 | 12 month |
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Baseline |
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 3 month |
| Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 12 month |
| 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. | Baseline |
| 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. | 3 month |
| 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. | 12 month |
| 2 Minute Walk | Distance walked in two minutes in meters | Baseline |
| 2 Minute Walk | Distance walked in two minutes in meters | 3 month |
| 2 Minute Walk | Distance walked in two minutes in meters | 12 month |
| Background |
| Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643. |
| 18566924 | Result | Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper P, McConnell E, Bosworth H, Ekelund C, Pearson M, Howard T. Project LIFE--Learning to Improve Fitness and Function in Elders: methods, design, and baseline characteristics of randomized trial. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044. |
| 19467149 | Result | Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Pearson MP. The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men. J Am Geriatr Soc. 2009 Jul;57(7):1166-74. doi: 10.1111/j.1532-5415.2009.02301.x. Epub 2009 May 8. |
| 20387023 | Result | Hall KS, Crowley GM, McConnell ES, Bosworth HB, Sloane R, Ekelund CC, Morey MC. Change in goal ratings as a mediating variable between self-efficacy and physical activity in older men. Ann Behav Med. 2010 Jun;39(3):267-73. doi: 10.1007/s12160-010-9177-5. |
| 20429674 | Result | Huffman KM, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention. Scand J Rheumatol. 2010 May;39(3):233-9. doi: 10.3109/03009740903348973. |
| 20604671 | Result | Huffman KM, Hall KS, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis? Scand J Rheumatol. 2010;39(5):380-6. doi: 10.3109/03009741003605630. |
| 20956844 | Result | Hall KS, Crowley GM, Bosworth HB, Howard TA, Morey MC. Individual progress toward self-selected goals among older adults enrolled in a physical activity counseling intervention. J Aging Phys Act. 2010 Oct;18(4):439-50. doi: 10.1123/japa.18.4.439. |
| 21234104 | Result | Hall KS, Sloane R, Pieper CF, Peterson MJ, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Morey MC. Long-term changes in physical activity following a one-year home-based physical activity counseling program in older adults with multiple morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407. |
| 21367961 | Result | Lum H, Sloane R, Huffman KM, Kraus VB, Thompson DK, Kraus WE, Bain JR, Stevens R, Pieper CF, Taylor GA, Newgard CB, Cohen HJ, Morey MC. Plasma acylcarnitines are associated with physical performance in elderly men. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2. |
| Lost to Follow-up |
|
| BG001 | Arm 2 | Usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | This study was conducted at a VA Medical Center. Only 3 females were randomized into the study which was not unexpected given the targeted sample and relative paucity of females in VA receiving care in this particular age group at the time. On submitting primary paper, the authors were required to eliminate the females from the study. No females were included in data presented | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Number of participants completing a categorical level of education as described | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Number of diseases | By self report from a list of 35 conditions adapted from the Older Americans Resources and Services survey | Mean | Standard Deviation | Diseases |
|
| Health quality of life of excellent or very good | Reported as the number of participants who reported health quality of life as excellent or very good from a 5 point likert scale ranging from poor to excellent | Number | participants |
|
| Assistive device | Number of participants reporting the use of an assistive device | Number | participants |
|
Usual care |
|
|
| 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 | Posted | Mean | Standard Deviation | times per week | Baseline |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | times per week | 3 month |
|
|
|
| Primary | Usual Gait Speed | Posted | Mean | Standard Deviation | meters/second | 3 month |
|
|
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| Primary | Usual Gait Speed | Posted | Mean | Standard Deviation | meters/second | 12-month |
|
|
|
|
| Primary | Rapid Gait Speed | Posted | Mean | Standard Deviation | meters/second | Baseline |
|
|
|
| Primary | Rapid Gait Speed | Posted | Mean | Standard Deviation | meters/second | 3-month |
|
|
|
| Primary | Rapid Gait Speed | Posted | Mean | Standard Deviation | meters/second | 12-month |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | times per week | 12 month |
|
|
|
|
| Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Posted | Number | participants | 3 month |
|
|
|
| Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Posted | Number | participants | 12 month |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 3 month |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 month |
|
|
|
|
| Secondary | 2 Minute Walk | Distance walked in two minutes in meters | Posted | Mean | Standard Deviation | meters | Baseline |
|
|
|
| Secondary | 2 Minute Walk | Distance walked in two minutes in meters | Posted | Mean | Standard Deviation | meters | 3 month |
|
|
|
| Secondary | 2 Minute Walk | Distance walked in two minutes in meters | Posted | Mean | Standard Deviation | meters | 12 month |
|
|
|
|
| 0 |
| 199 |
| 3 |
| 199 |
| EG001 | Arm 2, Usual Care | Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial | 0 | 199 | 0 | 199 |
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