Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335491
Status:
COMPLETED
Last Update Posted:
2011-09-30
First Post:
2006-06-08
Brief Title:
Exercise in Improving Mobility and Reducing Fatigue andor Weakness in Older Cancer Survivors
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
A RENEW Intervention for Elderly Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
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:
RATIONALE Exercise may help improve mobility and relieve fatigue andor weakness in cancer survivors It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue andor weakness in older cancer survivors
PURPOSE This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue andor weakness in older cancer survivors
PURPOSE This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue andor weakness in older cancer survivors
Detailed Description:
OBJECTIVES
Compare the perception of and the patterns of change in fatigue weakness physical activity level and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work RENEW vs standard care
Compare changes in muscle structure function strength power production and metabolic function and mobility
Evaluate the patients adherence to and satisfaction with the RENEW intervention
OUTLINE This is a prospective randomized controlled longitudinal study Patients are randomized to 1 of 2 intervention arms
Arm I Patients undergo resistance exercise via negative-eccentric work RENEW using a special seated stationary leg exercise machine 3 times a week for up to 12 weeks Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW
Arm II Patients receive standard care In both arms fatigue weakness physical activity functional status muscle structure and function and mobility are assessed at baseline and then at 12 weeks after completion of study intervention Fatigue and weakness are also assessed weekly during study intervention Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Compare the perception of and the patterns of change in fatigue weakness physical activity level and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work RENEW vs standard care
Compare changes in muscle structure function strength power production and metabolic function and mobility
Evaluate the patients adherence to and satisfaction with the RENEW intervention
OUTLINE This is a prospective randomized controlled longitudinal study Patients are randomized to 1 of 2 intervention arms
Arm I Patients undergo resistance exercise via negative-eccentric work RENEW using a special seated stationary leg exercise machine 3 times a week for up to 12 weeks Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW
Arm II Patients receive standard care In both arms fatigue weakness physical activity functional status muscle structure and function and mobility are assessed at baseline and then at 12 weeks after completion of study intervention Fatigue and weakness are also assessed weekly during study intervention Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| UUMC-R21CA114523 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA042014 |
| R21CA114523 | NIH | None | None |
| P30CA042014 | NIH | None | None |