Aging Clinical Trial
— Project LIFEOfficial title:
Life 2: Improving Fitness and Function in Elders
Verified date | January 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 70 Years and older |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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. — View Citation
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. — View Citation
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 mo — View Citation
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( — View Citation
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( — View Citation
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; — View Citation
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. — View Citation
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 counsel — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usual Gait Speed | Best of two trials over 8-foot walk | Baseline | No |
Primary | Usual Gait Speed | 3 month | No | |
Primary | Usual Gait Speed | 12-month | No | |
Primary | Rapid Gait Speed | Baseline | No | |
Primary | Rapid Gait Speed | 3-month | No | |
Primary | Rapid Gait Speed | 12-month | No | |
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 | Baseline | No |
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 | 3 month | No |
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 | 12 month | No |
Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | Baseline | No |
Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 3 month | No |
Secondary | Self Rated Health | Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good | 12 month | No |
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. | Baseline | No |
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. | 3 month | No |
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. | 12 month | No |
Secondary | 2 Minute Walk | Distance walked in two minutes in meters | Baseline | No |
Secondary | 2 Minute Walk | Distance walked in two minutes in meters | 3 month | No |
Secondary | 2 Minute Walk | Distance walked in two minutes in meters | 12 month | No |
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