Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-20 @ 4:41 AM
Study NCT ID:
NCT01355861
Status:
WITHDRAWN
Last Update Posted:
2015-06-26
First Post:
2011-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Exercise for the Prevention of Age-related Sarcopenia
Sponsor:
US Department of Veterans Affairs
Organization:
Study Overview
Official Title:
Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project has been withdrawn from funding consideration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAiRS
Brief Summary:
The purpose of this study is to determine the benefits of negative work progressive resistance exercise (PRE) for the conservative management of sarcopenia in older male Veterans at the DC VAMC. Efficacy will be assessed by examining post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.
Detailed Description:
The chief aim of this protocol is to determine the efficacy of negative work progressive resistance exercise (PRE) in the management of sarcopenia in older male Veterans at the DC VAMC. This proposed study is a randomized clinical trial using a single-arm, delayed cross-over design with repeated measures. This method is a patient-first approach to clinical research that permits all participants to receive the intervention while allowing the investigators to conduct both within subjects and between subjects comparisons with a modest study enrollment. During the "pre-treatment period" we will recruit, screen, and consent 30 older men with sarcopenia. The participants will be randomized into two groups: active treatment and delayed treatment. The initial "active treatment" and "delayed treatment" periods will last 12 weeks. After 12 weeks, the participants in the delayed treatment group will crossover (without a washout period) and start 12 weeks of intervention. All participants will detrain and be monitored for follow up during their respective 12-week "post treatment" period. Outcome measures include post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.
Study Oversight
Has Oversight DMC:
False
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?: