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

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Aging; Sarcopenia

Treatments: Behavioral: High-intensity progressive resistance training; Other: General practitioner care

Study type: Interventional

Funder types: Other

Identifiers

NCT05691166

2022/462261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 80+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 80 years or older
• Low muscular strength (grip strength: <41.3 kg for males and <23.4 kg for females [from 18.09.2024] or chair stand >15 seconds)
• Community-dwelling incl. independent senior housing
• Ambulatory without supervision or physical assistance from another person. Assistive devices such as canes/crutches/walkers allowed.
• Able to see and hear sufficiently to undertake assessments and partake in the planned exercise training.

Exclusion criteria

• Pre-existing diagnosis of dementia
• Moderate or severe cognitive impairment (score <18 on the Mini-Mental State Examination)
• Living in institutional care
• Non-ambulatory or requiring person or wheelchair to assist when walking
• Degenerative neurological and neuromuscular disease/disorder significantly influencing gait and mobility (e.g. amyotrophic lateral sclerosis [ALS] and Parkinson's disease).
• Amputation (other than toes)
• Contraindications to resistance training
• Unstable fracture
• Inability to comply with study requirements
• Currently undertaking progressive resistance training

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

Progressive resistance training

Experimental group

Description:

Twice weekly high-intensity progressive resistance training for 12 months

Treatment:

Behavioral: High-intensity progressive resistance training

Control

Active Comparator group

Description:

Participants randomised to the control group receive a booklet containing Norway's current recommendations for physical activity for older adults. These recommendations mean ≥150 minutes of moderate-intensity or ≥75 minutes of vigorous-intensity physical activity per week and two to three weekly balance and resistance training sessions. The booklet also includes pictures and instructions for seven exercises to help prevent falls.

Treatment:

Other: General practitioner care