Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421681
Status:
UNKNOWN
Last Update Posted:
2009-12-14
First Post:
2007-01-10
Brief Title:
Exercise Adherence Among Older Adults With Osteoarthritis
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Exercise Adherence Among Older Adults With Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the comparative effects of two different ways of enhancing long-term adherence to and benefits associated with participation in the evidence-based Fit and Strong multi-component exercise intervention for older persons with lower extremity osteoarthritis
Detailed Description:
Osteoarthritis OA is the most common condition affecting older people today It is the leading cause of disability among older people and its impact is projected to increase substantially with the aging of the US population from 43 million currently to 60 million by 2020
Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA The Fit and Strong intervention developed and tested as part of the Midwest Roybal Center for Health Maintenance coupled strength training and aerobic walking with health education for sustained behavior change Improvements have been found in confidence in ability to exercise confidence in ability to continue exercising over time lower extremity stiffness lower extremity pain and 6-minute distance walk Importantly the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls
The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiatedtailored follow-up maintenance strategy vs a mainstreaming facility-based maintenance strategy both of which will be tested with and without telephone reinforcement as an enhancement
All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups There is no more than minimal risk associated with this program
Promising 2- and 6-month outcomes have recently been reported from a randomized trial of a multi-component exercise intervention targeted at older adults with lower extremity OA The Fit and Strong intervention developed and tested as part of the Midwest Roybal Center for Health Maintenance coupled strength training and aerobic walking with health education for sustained behavior change Improvements have been found in confidence in ability to exercise confidence in ability to continue exercising over time lower extremity stiffness lower extremity pain and 6-minute distance walk Importantly the average adherence rate in the people who participated in the exercise intervention at six months was twice that reported by controls
The specific aims of this study are to use a multi-site randomized controlled clinical trial to replicate the Fit and Strong intervention and to test the comparative effectiveness of a negotiatedtailored follow-up maintenance strategy vs a mainstreaming facility-based maintenance strategy both of which will be tested with and without telephone reinforcement as an enhancement
All enrolled participants will participate in the 8-week Fit and Strong exercise program designed specifically for older adults with lower-extremity OA Prior to the conclusion of Fit and Strong participants will be randomly assigned to one of two follow-up maintenance groups There is no more than minimal risk associated with this program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG023424 | NIH | None | httpsreporternihgovquickSearch5R01AG023424 |