Reducing Falls With Progressive Resistance Training (ReFit) for the Oldest Old Adults With Sarcopenia. A 12-month Randomised Controlled Trial (RCT).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
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.
详细描述
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Falls
时间窗: 12 months
Relative risk for falls, fall rate per person years. Self-report.
次要结局
- Dynamic muscular strength(6 and 12 months)
- Dynamic muscular strength(6 and 12 months)
- Falls requiring medical attention(6, 12, 24, 36 months)
- Fall-related injuries(6, 12, 24, 36 months)
- Falls(6, 12, 24, and 36 months.)
- Grip strength(6, 12, 24, 36 months)
- Muscular power(6 and 12 months)
- Physical performance(6, 12, 24, 36 months)
- Balance(6, 12, 24, 36 months)
- Stature(6, 12, 24, 36 months)
- Body mass(6, 12, 24, 36 months)
- Body composition(6, 12, 24, 36 months)
- Circumferences(6 and 12 months)
- Resting blood pressure and resting heart rate(6, 12, 24, 36 months)
- Orthostatic blood pressure(6, 12, 24, 36 months)
- Physical activity(6, 12, 24, 36 months)
- Health-related quality of life(6, 12, 24, 36 months)
- Fear of falling(6, 12, 24, 36 months)
- Cognitive function(6 and 12 months)
- Depression(6, 12, 24, 36 months)
- Frailty(6, 12, 24, 36 months)
- Nutritional status(6, 12, 24, 36 months)
- Sleep quality(6, 12, 24, 36 months)
- Hospital admissions(0-12 months and 0-36 months)
- Use of primary health care, community care, and assistive technology(0-12 months and 0-36 months)
- Use of prescription drugs(12 months)
- Disability-free survival (DFS)(Baseline to 36 months post-randomisation)
- Healthcare and implementation costs(0-12 months)
- Quality-Adjusted Life-Years (QALY's)(0-12 months)
- Falls(6 months)