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

Aging Clinical Trial

— ReFit  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05691166
• Other study ID #: 2022/462261
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Aged 80 years or older
• Low muscular strength (grip strength: <39.6 kg for males and <21.8 kg for females 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

Related Conditions & MeSH terms

• Aging
• Sarcopenia

Intervention

Behavioral:
• High-intensity progressive resistance training
Supervised high-intensity progressive resistance training twice per week for 12 months

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.

Locations

Country	Name	City	State
Norway	Department of Circulation and Medical Imaging	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes in cardiac structure and function	Echocardiographic indices of atrial and ventricular structure and function	12 months
Other	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.	12 months
Other	Cognitive function	Cognitive function assessed using Mini-Mental State Examination (MMSE)	12 months
Primary	Falls	Relative risk for falls, fall rate per person years. Self-report.	12 months
Secondary	Falls	Relative risk for falls, fall rate per person years. Self-report.	6 months
Secondary	Falls	Number of falls, number of fallers/nonfallers/frequent fallers, and time to first fall. Self-report.	6 and 12 months
Secondary	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 and 12 months
Secondary	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 and 12 months
Secondary	Dynamic muscular strength	1-repetition maximum leg press and leg extension	6 and 12 months
Secondary	Grip strength	Maximal isometric handgrip strength	6 and 12 months
Secondary	Muscular power	Muscular power assessed using a force platform installed on a leg press machine	6 and 12 months
Secondary	Physical performance	Physical performance using the Short Physical Performance Battery	6 and 12 months
Secondary	Gait characteristics	Gait characteristics during a 4-m walk on the GAITrite electronic gait mat	6 and 12 months
Secondary	Balance	Static and dynamic balance using the Mini-Balance Evaluation Systems Test (BESTest) and a 3-m tandem walk	6 and 12 months
Secondary	Stature	Stretch stature using a wall-mounted stadiometer	6 and 12 months
Secondary	Body mass	Body mass estimated using multi-frequency bioelectrical impedance analysis	6 and 12 months
Secondary	Body composition	Estimated using multi-frequency bioelectrical impedance analysis. Fat mass, skeletal muscle mss, appendicular skeletal muscle mass.	6 and 12 months
Secondary	Circumferences	Waist, arm, and calf circumference	6 and 12 months
Secondary	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 and 12 months
Secondary	Orthostatic blood pressure	Systolic and diastolic blood pressure response 1, and 3-min after standing up	6 and 12 months
Secondary	Physical activity	Self-reported physical activity levels	6 and 12 months
Secondary	Health-related quality of life	Health-related quality of life assessed using the 12-item Short-form health survey	6 and 12 months
Secondary	Fear of falling	Fear of falling assessed using the Falls Efficacy Scale-International	6 and 12 months
Secondary	Cognitive function	Cognitive function evaluated using The Mini Mental State Examination	6 and 12 months
Secondary	Depression	Levels of depression measured via the Geriatric Depression Scale.	6 and 12 months
Secondary	Frailty	Physical frailty assessed according to Fried's frailty phenotype	6 and 12 months
Secondary	Nutritional status	Nutritional status assessed using the Mini-nutritional Assessment Short form.	6 and 12 months
Secondary	Sleep quality	Sleep quality assessed using the Pittsburgh Sleep Quality Index	6 and 12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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