Life 2: Improving Fitness and Function in Elders

Aging Clinical Trial

— Project LIFE  

Official title:

Life 2: Improving Fitness and Function in Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435188
• Other study ID #: E3386-R
• Status: Completed
• Phase: N/A
• First received: February 12, 2007
• Last updated: January 8, 2015
• Start date: November 2004
• Est. completion date: April 2008

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging
• Mobility Limitation
• Mobility Limitations

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

Outcome

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

External Links

•   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.