Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05691166
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.
Study:
NCT05691166
Study Brief:
Protocol Section:
NCT05691166