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Life 2: Improving Fitness and Function in Elders (Project LIFE)

Primary Purpose

Aging, Mobility Limitations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-component physical activity counseling program
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care, Randomized Clinical Trial, Veterans

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

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

Usual care

Outcomes

Primary Outcome Measures

Usual Gait Speed
Best of two trials over 8-foot walk
Usual Gait Speed
Usual Gait Speed
Rapid Gait Speed
Rapid Gait Speed
Rapid Gait Speed

Secondary Outcome Measures

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
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
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
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Self Rated Health
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
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.
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.
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.
2 Minute Walk
Distance walked in two minutes in meters
2 Minute Walk
Distance walked in two minutes in meters
2 Minute Walk
Distance walked in two minutes in meters

Full Information

First Posted
February 12, 2007
Last Updated
January 8, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00435188
Brief Title
Life 2: Improving Fitness and Function in Elders
Acronym
Project LIFE
Official Title
Life 2: Improving Fitness and Function in Elders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mobility Limitations
Keywords
Aging, Cost analysis, Counseling, Disabled Persons, Health Promotion, Mobility Limitation, Physical Activity, Primary Care, Randomized Clinical Trial, Veterans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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 Title
Arm 2
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Multi-component physical activity counseling program
Intervention Description
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
Primary Outcome Measure Information:
Title
Usual Gait Speed
Description
Best of two trials over 8-foot walk
Time Frame
Baseline
Title
Usual Gait Speed
Time Frame
3 month
Title
Usual Gait Speed
Time Frame
12-month
Title
Rapid Gait Speed
Time Frame
Baseline
Title
Rapid Gait Speed
Time Frame
3-month
Title
Rapid Gait Speed
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Physical Activity Frequency (CHAMPS Questionnaire)
Description
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
Title
Physical Activity Frequency (CHAMPS Questionnaire)
Description
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
Title
Physical Activity Frequency (CHAMPS Questionnaire)
Description
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
Title
Self Rated Health
Description
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Time Frame
Baseline
Title
Self Rated Health
Description
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Time Frame
3 month
Title
Self Rated Health
Description
Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good
Time Frame
12 month
Title
Sf-36 Physical Function Subscale
Description
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
Title
Sf-36 Physical Function Subscale
Description
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
Title
Sf-36 Physical Function Subscale
Description
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
Title
2 Minute Walk
Description
Distance walked in two minutes in meters
Time Frame
Baseline
Title
2 Minute Walk
Description
Distance walked in two minutes in meters
Time Frame
3 month
Title
2 Minute Walk
Description
Distance walked in two minutes in meters
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam C. Morey, PhD
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19117329
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.
Results Reference
background
PubMed Identifier
19436015
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.
Results Reference
background
PubMed Identifier
18566924
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. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044.
Results Reference
result
PubMed Identifier
19467149
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 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.
Results Reference
result
PubMed Identifier
20387023
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.
Results Reference
result
PubMed Identifier
20429674
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(3):233-9. doi: 10.3109/03009740903348973.
Results Reference
result
PubMed Identifier
20604671
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(5):380-6. doi: 10.3109/03009741003605630.
Results Reference
result
PubMed Identifier
20956844
Citation
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.
Results Reference
result
PubMed Identifier
21234104
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 morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407.
Results Reference
result
PubMed Identifier
21367961
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;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2.
Results Reference
result
Links:
URL
http://www.research.va.gov/resources/pubs/LIFE-modules.cfm
Description
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.

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Life 2: Improving Fitness and Function in Elders

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