Reducing Falls With Progressive Resistance Training for the Oldest Old Adults With Sarcopenia
- Conditions
- SarcopeniaAging
- Interventions
- Behavioral: High-intensity progressive resistance trainingOther: General practitioner care
- Registration Number
- NCT05691166
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Progressive resistance training High-intensity progressive resistance training Twice weekly high-intensity progressive resistance training for 12 months Control General practitioner care Referred to general practitioner
- Primary Outcome Measures
Name Time Method Falls 12 months Relative risk for falls, fall rate per person years. Self-report.
- Secondary Outcome Measures
Name Time Method Nutritional status 6 and 12 months Nutritional status assessed using the Mini-nutritional Assessment Short form.
Depression 6 and 12 months Levels of depression measured via the Geriatric Depression Scale.
Falls 6 and 12 months Number of falls, number of fallers/nonfallers/frequent fallers, and time to first fall. Self-report.
Balance 6 and 12 months Static and dynamic balance using the Mini-Balance Evaluation Systems Test (BESTest) and a 3-m tandem walk
Fall-related injuries 6 and 12 months 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.
Orthostatic blood pressure 6 and 12 months Systolic and diastolic blood pressure response 1, and 3-min after standing up
Dynamic muscular strength 6 and 12 months 1-repetition maximum leg press and leg extension
Muscular power 6 and 12 months Muscular power assessed using a force platform installed on a leg press machine
Stature 6 and 12 months Stretch stature using a wall-mounted stadiometer
Cognitive function 6 and 12 months Cognitive function evaluated using The Mini Mental State Examination
Falls requiring medical attention 6 and 12 months 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.
Grip strength 6 and 12 months Maximal isometric handgrip strength
Physical performance 6 and 12 months Physical performance using the Short Physical Performance Battery
Body mass 6 and 12 months Body mass estimated using multi-frequency bioelectrical impedance analysis
Body composition 6 and 12 months Estimated using multi-frequency bioelectrical impedance analysis. Fat mass, skeletal muscle mss, appendicular skeletal muscle mass.
Physical activity 6 and 12 months Self-reported physical activity levels
Health-related quality of life 6 and 12 months Health-related quality of life assessed using the 12-item Short-form health survey
Gait characteristics 6 and 12 months Gait characteristics during a 4-m walk on the GAITrite electronic gait mat
Resting blood pressure and resting heart rate 6 and 12 months Systolic and diastolic blood pressure, and resting heart rate measured after 5 minutes of seated resting using an automated blood pressure device
Fear of falling 6 and 12 months Fear of falling assessed using the Falls Efficacy Scale-International
Use of primary health care, community care, and assistive technology 12 months 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.
Use of prescription drugs 12 months 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.
Circumferences 6 and 12 months Waist, arm, and calf circumference
Hospital admissions 12 months 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.
Frailty 6 and 12 months Physical frailty assessed according to Fried's frailty phenotype
Sleep quality 6 and 12 months Sleep quality assessed using the Pittsburgh Sleep Quality Index
Trial Locations
- Locations (1)
Department of Circulation and Medical Imaging
🇳🇴Trondheim, Norway