Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Assess the improvement of muscle mass
研究概览
简要总结
Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.
详细描述
Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.
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
- Double (Participant, Investigator)
盲法说明
The assessments will be conducted for a second investigator to ensure the blinding of first investigator. The subjects will be randomised in four groups (low frequency, high frequency, low and high frequency and sham stimulation) to ensure the blinding of participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease
- •Classical hemodialysis
- •Over 18 years old
- •No pace maker
- •Without cognitive or motor deficit
- •No regular physical activity in the last six months
排除标准
- •Abstention for more than two consecutive sessions or four in total
- •Inability to perform the tests
结局指标
主要结局
Assess the improvement of muscle mass
时间窗: Eight weeks
The muscle mass will be assessed by electric bioimpedance
Assess the improvement of muscle strength
时间窗: Eight weeks
The muscle strength will be assessed using isokinetic by peak torque
Assess the improvement of muscle resistance
时间窗: Eight weeks
The muscle resistance will be assessed using isokinetic by fatigue index
次要结局
- Assess the improvement of intervention in functional capacity(Eight weeks)
- Correlate peripheral muscle function with body composition(Eight weeks)
- Assess the improvement of intervention in quality of life(Eight weeks)
- Assess the improvement of intervention in hemodialysis effusion(Eight weeks)
- Correlate peripheral muscle function with functional capacity(Eight weeks)
- Correlate peripheral muscle function using medical research council score with nutritional status(Eight weeks)
- Correlate peripheral muscle function using hand grip with nutritional status(Eight weeks)
研究者
Wellington Yamaguti
Wellington Pereira dos Santos Yamaguti
Hospital Sirio-Libanes