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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcopenia, Aging

Intervention / Treatment
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* Behavioral: High-intensity progressive resistance training
* Other: General practitioner care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 80 years or older Low muscular strength (grip strength: <34.8 kg for males and <18.8 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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive resistance training<br>Twice weekly high-intensity progressive resistance training for 12 months | Behavioral: High-intensity progressive resistance training<br>* Supervised high-intensity progressive resistance training twice per week for 12 months<br>|
| Active Comparator: Control<br>Referred to general practitioner | Other: General practitioner care<br>* 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.<br>|

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