Effects of Whole-body Electrostimulation on Functional Mobility and Quality of Life in the Elderly: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D).
研究概览
简要总结
Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. The primary outcomes of this study are functional mobility (Timed Up and Go test) and quality of life (EQ-5D questionnaire). Functional mobility will be assessed at baseline, after 4 and 8 weeks of treatment or follow-up. Quality of life will be assessed only at the beginning and end of 8 weeks.
详细描述
Elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. Rehabilitation strategies similar to conventional exercise that minimize the damage caused by aging and improve subjects' adherence need to be studied. A randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). Whole-body electrical stimulation (WBS) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. Simultaneously with the WBS, the elderly will perform exercises for the upper, lower limbs and trunk. The following assessments will be carried out at baseline and 8 weeks to verify the effect of therapy: assessment of functional mobility; quality of life (EQ-5D); isometric muscle strength of the quadriceps muscles, biceps brachii and handgrip strength; lower limb muscle strength; assessment of body composition; assessment of cellular senescence; the inflammatory profile; well-being; measurement of muscle damage and pain; assessment of therapy safety and assessment of sleep quality. Assessments of functional mobility, lower limb muscle strength, cellular senescence; the inflammatory profile; well-being; and muscle damage will also be carried out in 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly people aged between 60 and 85 years;
- •Both sexes;
- •To have the ability to walk.
排除标准
- •Cognitive dysfunction;
- •Intolerance to electrical stimulator and/or changes in skin sensitivity;
- •Skin injuries or burns where the electrodes are positioned;
- •Sequelae of stroke;
- •Recent acute myocardial infarction;
- •Uncontrolled hypertension;
- •Grade IV heart failure or decompensated;
- •Unstable angina or arrhythmia;
- •Peripheral vascular changes in the lower limbs such as venous thrombosis deep;
- •Disabling osteoarticular or musculoskeletal disease;
- •Uncontrolled diabetes;
- •Autoimmune disease;
- •Pacemaker;
- •Epilepsy;
- •Hemophilia;
- •Chronic obstructive pulmonary disease;
- •Liver and kidney diseases;
- •Grade II obesity (BMI≥35).
结局指标
主要结局
Change in quality of life measured by the EuroQol five-dimensional questionnaire (EQ-5D).
时间窗: Baseline and after 8 weeks.
Change in quality of life will be assessed by the EuroQol five-dimensional questionnaire (EQ-5D). The final score of this questionnaire can vary from 0 to 1. The closer to 1, the better the subject's quality of life.
Functional mobility.
时间窗: Baseline, after 4 and 8 weeks.
Functional mobility will be assessed using the "Timed Up and Go" test.
次要结局
- Inflammatory profile.(Baseline, after 4 and 8 weeks.)
- Sleep quality.(Baseline and after 8 weeks.)
- Isometric muscle strength of the biceps brachii.(Baseline and after 8 weeks.)
- Well-being.(Baseline, after 4 and 8 weeks.)
- Muscle pain measured by analogic visual scale (AVS).(Baseline and after 8 weeks.)
- Change in diastolic blood pressure.(Baseline and after 20 minutes of whole-body electrical stimulation.)
- Muscle damage.(Baseline, after 4 and 8 weeks.)
- Isometric muscle strength of the quadriceps muscle.(Baseline and after 8 weeks.)
- Isometric handgrip strength.(Baseline and after 8 weeks.)
- Cellular senescence.(Baseline, after 4 and 8 weeks.)
- Change in heart rate.(Baseline and after 20 minutes of whole-body electrical stimulation.)
- Change in peripheral oxygen saturation.(Baseline and after 20 minutes of whole-body electrical stimulation.)
- Change in systolic blood pressure.(Baseline and after 20 minutes of whole-body electrical stimulation.)
- Lower limb muscle strength.(Baseline, after 4 and 8 weeks.)
- Body composition.(Baseline and after 8 weeks.)
研究者
Jociane Schardong
Principal Investigator
Federal University of Health Science of Porto Alegre