Clinical Trial: Safety, acceptability and tolerability of a 12-week high-velocity resistance training programme in community-dwelling older adults: a single-arm pilot study (Japan)

Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063376) titled 'Safety, acceptability and tolerability of a 12-week high-velocity resistance training programme in community-dwelling older adults: a single-arm pilot study' on Oct. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tartu Applied Health Sciences University

Condition: Condition - Community-dwelling older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the safety, acceptability and tolerability of a supervised 12-week high-velocity resistance training (HVRT) programme in community-dwelling older adults, and to describe exploratory changes in inhibitory control, physical function and body composition to inform the design of a future controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - High-velocity resistance training (HVRT) is performed under the supervision of a qualified physiotherapist. The intervention lasts 12 weeks, with 2 sessions per week (24 sessions in total). Each session lasts 45 to 60 minutes (approximately 50 minutes) and consists of a health check, a standardised warm-up (approximately 7 minutes), the main exercises (25 to 35 minutes) and a cool-down. The main exercises are five functional exercises performed wearing a weighted vest: chair stand, forward step-up, lateral step-up, hip hinge and calf raise. The concentric phase is performed as fast as safely possible and the eccentric phase over approximately 5 seconds. Sets and repetitions are 2 sets of 15 repetitions in weeks 1-4, 2 sets of 12 repetitions in weeks 5-8 and 3 sets of 8 repetitions in weeks 9-12. The target rating of perceived exertion (Borg RPE, 6-20) is progressively increased from 13 in week 1 to 17 from week 9. In week 1, participants learn the exercises wearing the vest without additional load. From week 2, the load is increased by approximately 1 to 2% of body weight when the prescribed volume is completed with correct form, RPE is within the target range and there are no safety concerns. The maximum external load is 15% of body weight.

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - 1) Community-dwelling adults aged 65-70 years; 2) able to walk independently without assistive devices; 3) able to understand study information and task instructions in Estonian; 4) provided written informed consent Key exclusion criteria - 1) Colour vision deficiency; 2) medical conditions contraindicating exercise, such as unstable cardiovascular disease or uncontrolled hypertension; 3) musculoskeletal or neurological conditions that limit exercise participation; 4) any other condition judged inappropriate by the principal investigator Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 22 Day Anticipated trial start date - 2026 Year 10 Month 24 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072549

Disclaimer: Curated by HT Syndication.