Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 8:46 AM
Study NCT ID:
NCT05691166
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-19
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia
Sponsor:
Norwegian University of Science and Technology
Organization:
Study Overview
Official Title:
Reducing Falls With Progressive Resistance Training (ReFit) for the Oldest Old Adults With Sarcopenia. A 12-month Randomised Controlled Trial (RCT).
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
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:
ReFit
Brief Summary:
This study will investigate the effects of 12 months of high-intensity progressive resistance training compared with a control group on fall-rate in older adults with sarcopenia.
Detailed Description:
Despite the wealth of theoretical benefits, existing literature on resistance training for falls prevention is not conclusive, given the sub-optimal resistance training paradigms, poor study quality, and use of multimodal training interventions, precluding isolation of the resistance training benefits. It is also possible that resistance training benefits for falls reduction will be most evident in those with sarcopenia to begin with as a risk factor for their falls. We will therefore conduct a randomised, controlled trial assessing the effects of resistance training reduce falls in the oldest old adults with sarcopenia, as well as to increase strength and muscle mass.
Amendments: 2024-09-18. We updated the low grip-strength inclusion criterion from \[Men:\<39.6kg, Women:\<21.4kg\] to \[Men:\<41.6kg, Women:23.4kg\] based on normative values (Ref: Svinøy, O. E., Hilde, G., Bergland, A., \& Strand, B. H. \[2023\]).
Extension amendment (2025-09-02): With new funding and ethics approval (REK 2022/462261), we added post-trial follow-up at 24 and 36 months to evaluate disability-free survival and the durability of effects on falls and several secondary outcomes. Falls during follow-up are collected via 12-month recall. No changes to interventions or the prespecified 0-12-month primary endpoints.
Amendments: 2024-09-18. We updated the low grip-strength inclusion criterion from \[Men:\<39.6kg, Women:\<21.4kg\] to \[Men:\<41.6kg, Women:23.4kg\] based on normative values (Ref: Svinøy, O. E., Hilde, G., Bergland, A., \& Strand, B. H. \[2023\]).
Extension amendment (2025-09-02): With new funding and ethics approval (REK 2022/462261), we added post-trial follow-up at 24 and 36 months to evaluate disability-free survival and the durability of effects on falls and several secondary outcomes. Falls during follow-up are collected via 12-month recall. No changes to interventions or the prespecified 0-12-month primary endpoints.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: