NCT05691166

Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia

Reducing Falls With Progressive Resistance Training (ReFit) for the Oldest Old Adults With Sarcopenia. A 12-month Randomised Controlled Trial (RCT).

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Accepted

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. Amendment 2023-12-15: The description of the control condition was updated following ethics committee approval. Referral to the general practitioner for follow-up was replaced with provision of written information on current physical activity recommendations for older adults. This change was made to improve acceptability and feasibility of the control condition; the study outcomes and intervention were unchanged. 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.

Conditions

• Sarcopenia
• Aging

Interventions

Type	Name	Description
BEHAVIORAL	High-intensity progressive resistance training	Supervised high-intensity progressive resistance training twice per week for 12 months
OTHER	General practitioner care	Referred to general practitioner (GP) for further follow-up. The GPs will be informed about participants sarcopenia status with results from assessments of muscle strength, muscle mass, and physical performance. The management of the sarcopenia is at the GPs own discretion.

Timeline

• Start date: 2023-03-30
• Primary completion: 2026-09-29
• Completion: 2028-09-29
• First posted: 2023-01-19
• Last updated: 2026-01-23

Locations

1 site across 1 country: Norway