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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenia; Aging
• Intervention / Treatment: Behavioral: High-intensity progressive resistance training; Other: General practitioner care

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.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • Department of Circulation and Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive resistance training; Twice weekly high-intensity progressive resistance training for 12 months	Behavioral: High-intensity progressive resistance training; Supervised high-intensity progressive resistance training twice per week for 12 months
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Relative risk for falls, fall rate per person years. Self-report.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Relative risk for falls, fall rate per person years. Self-report.	6 months
Dynamic muscular strength	1-repetition maximum leg press and leg extension	6 and 12 months
Muscular power	Muscular power assessed using a force platform installed on a leg press machine	6 and 12 months
Circumferences	Waist, arm, and calf circumference	6 and 12 months
Cognitive function	Cognitive function evaluated using The Mini Mental State Examination	6 and 12 months
Use of prescription drugs	Use of prescription drugs during the study will be collected by linkage to the Norwegian Prescribed Drug Registry with the use of a unique 11-digit Norwegian national identification number for each participant.	12 months
Falls	Number of falls, number of fallers/nonfallers/frequent fallers, and time to first fall. Self-report.	6, 12, 24, and 36 months.
Falls requiring medical attention	Number of falls requiring medical attention. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.	6, 12, 24, 36 months
Fall-related injuries	Classified according to the International Classification of Diseases, 11th revision, classification system. Peripheral fracture rate per person-years, number of peripheral fractures, number of people sustaining peripheral fractures, and number of people sustaining multiple events. Collected via self-report and ascertained by linkage to the Norwegian Patient Registry and medical journals with the use of unique 11-digit Norwegian national identification number for each participant.	6, 12, 24, 36 months
Grip strength	Maximal isometric handgrip strength	6, 12, 24, 36 months
Physical performance	Physical performance using the Short Physical Performance Battery	6, 12, 24, 36 months
Balance	Static and dynamic balance using the Mini-Balance Evaluation Systems Test (BESTest)	6, 12, 24, 36 months
Stature	Stretch stature using a wall-mounted stadiometer	6, 12, 24, 36 months
Body mass	Body mass estimated using multi-frequency bioelectrical impedance analysis	6, 12, 24, 36 months
Body composition	Estimated using multi-frequency bioelectrical impedance analysis. Fat mass, skeletal muscle mss, appendicular skeletal muscle mass.	6, 12, 24, 36 months
Resting blood pressure and resting heart rate	Systolic and diastolic blood pressure, and resting heart rate measured after 5 minutes of seated resting using an automated blood pressure device	6, 12, 24, 36 months
Orthostatic blood pressure	Systolic and diastolic blood pressure response 1, and 3-min after standing up	6, 12, 24, 36 months
Physical activity	Self-reported physical activity levels	6, 12, 24, 36 months
Health-related quality of life	Health-related quality of life assessed using the 12-item Short-form health survey	6, 12, 24, 36 months
Fear of falling	Fear of falling assessed using the Falls Efficacy Scale-International	6, 12, 24, 36 months
Depression	Levels of depression measured via the Geriatric Depression Scale.	6, 12, 24, 36 months
Frailty	Physical frailty assessed according to Fried's frailty phenotype	6, 12, 24, 36 months
Nutritional status	Nutritional status assessed using the Mini-nutritional Assessment Short form.	6, 12, 24, 36 months
Sleep quality	Sleep quality assessed using the Pittsburgh Sleep Quality Index	6, 12, 24, 36 months
Hospital admissions	Information about hospitalisations due to falls and fall-related injuries will be collected by means of electronic linkage to the Norwegian Patient Registry and medical journals with the use of a unique 11-digit Norwegian national identification number for each participant.	0-12 months and 0-36 months
Use of primary health care, community care, and assistive technology	Use of primary health care (general practitioner, emergency room, physiotherapist, and chiropractor), community care, and assistive technology during the study will be collected by linkage to the Norwegian Municipal Patient and User Register (KPR) database with the use of a unique 11-digit Norwegian national identification number for each participant.	0-12 months and 0-36 months
Disability-free survival (DFS)	DFS is defined as time from randomization to the first occurrence of: (i) death from any cause; (ii) incident dementia; or (iii) incident ADL disability. Participants with dementia or ADL disability at baseline are excluded from the DFS analysis. Death: ascertained by linkage to the Norwegian Cause of Death Registry. Incident ADL disability: score of 3-5 any of the six primary ADLs (Physical Self-Maintenance Scale) or a score of 0 for any of the five instrumental ADLs (Lawton IADL Scale). If ADL status cannot be obtained, admission to long-term nursing care (national registries) will be used as a proxy for disability. Incident dementia: registry/clinical diagnosis (ICD-10 F00-F03, G30, or equivalent codes in national registries). Exploratory supplement: MoCA assessed at 24/36 months; dementia defined as MoCA z-score ≤ -2.0 (age/education-adjusted).	Baseline to 36 months post-randomisation
Healthcare and implementation costs	Intervention costs (resistance training and control), prescription medication, and health and care service utilisation during the 12-month intervention period. Costs for the training intervention include fitness centre membership fees and instructor labour costs (time worked + overheads). We will not consider potential travel costs for participants. We will obtain expenses related to prescription medication and health care service utilisation by linking participant data with data from the Norwegian Prescribed Drug Registry, the Norwegian Patient Registry (specialist health services), and the Municipal Patient and User Register (primary care, care services, physiotherapist, and chiropractor). We focus only on implementation costs, thus disregarding research protocol costs (e.g. recruitment).	0-12 months
Quality-Adjusted Life-Years (QALY's)	We use the 12-item short-form health survey (SF-12) to assess health-related quality of life across eight areas, with scores summed into a physical component summary score and a mental component summary score, ranging from 0 to 100, with higher scores indicating a better quality of life.32 Next, we'll convert the SF-12 scores into SF-6D utility scores using the equation by Brazier and Roberts (2004).33 The utility scores range from 0 (equivalent to death) to 1 (equivalent to perfect health). Finally, we'll calculate QALYs for the 12-month intervention period by linearly interpolating SF-6D utility scores for baseline, six, and 12 months	0-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal pain	Musculoskeletal pain assessed using the "yes" or "no" question, "during the last year have you had pain in your muscles and/or joints that lasted for at least 3 consecutive months?". When answering "yes", participants will be asked to indicate the affected body areas. In addition, we will assess pain intensity for lower back and neck, specifically, using a 10-cm visual analogue scale (VAS).	6 and 12 months
Changes in cardiac structure and function	Echocardiographic indices of atrial and ventricular structure and function	12 months
Mortality	During the study unreported mortality will be assessed twice per year by linkage to the Norwegian population registry with the use of a unique 11-digit Norwegian national identification number for each participant.	0-12 and 0-36 months
Cognitive function	Montreal Cognitive Assessment Tool	24 and 36 months
Protein intake	Using the Protein Screener 55+	12, 24, 36 months
Incremental cost-effectiveness ratio (ICER)	We will analyse the cost-effectiveness by estimating the Incremental Cost-Effectiveness Ratio (ICER) between the resistance training and control groups. We consider resistance training cost-effective if the ICER falls below the willingness-to-pay threshold (WTP).	0-12 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Study Director: Øivind Rognmo, PhD, Norwegian University of Science and Technology; Principal Investigator: Jonathan Berg, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): September 29, 2028

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: 2022/462261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No