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

NCT ID: NCT05691166

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2028-09-29

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Progressive resistance training

Twice weekly high-intensity progressive resistance training for 12 months

Group Type: EXPERIMENTAL

High-intensity progressive resistance training

Intervention Type: BEHAVIORAL

Supervised high-intensity progressive resistance training twice per week for 12 months

Control

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.

Group Type: ACTIVE_COMPARATOR

General practitioner care

Intervention Type: OTHER

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.

Interventions

High-intensity progressive resistance training

Supervised high-intensity progressive resistance training twice per week for 12 months

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Berg, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Øivind Rognmo, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Department of Circulation and Medical Imaging

Trondheim, , Norway

Countries

Norway

Other Identifiers

2022/462261

Identifier Type: -

Identifier Source: org_study_id