Neuromuscular Electrical Stimulation During Hemodialysis in Peripheral Muscle Strength and Exercise Capacity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Peripheral muscle strength
研究概览
简要总结
The objective of this study will be to evaluate the effects of neuromuscular electrical stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on peripheral muscle strength, exercise capacity and muscle change and inflammation markers in patients with chronic kidney disease (CKD).
详细描述
Clinical trial, randomized, parallel, open, two-arm, blinded assessor, prospective.
Patients with chronic kidney disease on hemodialysis, divided equally into two groups: group of high frequency and intensity neuromuscular electrical stimulation (HG) and a group of low frequency and intensity neuromuscular electrical stimulation (LG).
Randomization was stratified according to gender using 4 block. Drug treatment established for both groups remained unchanged throughout the study period.
Assessments were made on the first working day after hemodialysis, following notification and consent of the medical teams. Patients initially underwent anthropometric measurements and vital signs, later carried out the assessment of peripheral muscle strength, pulmonary function test, submaximal exercise capacity and quality of life questionnaire and depression. After these procedures, the patients were randomized to select HG or LG by opaque envelopes. These evaluations were performed at baseline and after 12 sessions of completion of the protocol.
Furthermore, it was asked to chronic kidney disease (CKD) patients on hemodialysis who presented their latest blood tests clearance index (Kt / V), creatinine, glomerular filtration rate. The evaluation of pro-inflammatory cytokines and regulatory plasma, the enzyme markers of muscle tropism, oxidative stress and muscle injury in patients with CKD was always held at the end of each month as routine clinical.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD diagnostic who are on dialysis regularly for at least 6 months, stable and under medical supervision.
- •Patients without uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
- •Patients without diseases that limit the electrical stimulation protocol (respiratory, orthopedic and / or neurological).
- •Patients who do not do any form of physical training or who have been held for more than six months.
排除标准
- •Inability to perform any of the study assessments (lack of understanding or collaboration).
- •Recent decompensation of the clinical picture with or without hospitalization.
- •Presence of chronic obstructive pulmonary disease (COPD or emphysema), musculoskeletal diseases that impede the realization of assessments and training protocol.
- •Uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
- •Abnormal sensitivity in the lower limbs.
结局指标
主要结局
Peripheral muscle strength
时间窗: one month
Increased quadriceps strength evaluated by the Isokinetic Biodex System 4 Pro in isometric mode. The highest peak extensor torque is recorded.
Six-minute walk test
时间窗: one month
It will be used to evaluate submaximal exercise capacity and will be held in accordance with the recommendations of the American Thoracic Society (Holland et al, 2014.). The larger distance between the two tests will be used for the analysis, this being compared to pre and after training. The reference values are those described by Britto et al., 2013 and an increase of 25 meters after the training will be considered a clinically important improvement.
次要结局
- glomerular filtration rate(one month)
- muscle trophism markers(one month)
- oxidative stress(one month)
- markers of muscle damage(one month)
- Quality of life(one month)
- Pulmonary function test(one month)
- Anxiety and Depression(one month)
- pro and anti-inflammatory cytokines(one month)
- urea clearance(one month)
研究者
Ana Karla Vieira Brüggemann
Principal Investigator
University of the State of Santa Catarina