Effects of Intra-dialytic Low-frequency Electrical Muscle Stimulation and Cycle Training on Cardiorespiratory Function and Muscular Strength: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Peak oxygen uptake (VO2peak)
研究概览
简要总结
The purpose of the trial is to compare the effects of intra-dialytic low-frequency electrical muscle stimulation and intra-dialytic cycling, with usual care haemodialysis without exercise training.
详细描述
End stage renal disease is associated with reduced functional capacity. Dynamic exercise training i.e. cycling, performed between dialysis sessions or during dialysis (intra-dialytic) can be effective in improving functional capacity and quality of life. However, many patients are unable to engage in intra-dialytic cycling due to limiting comorbidities. Other exercise modalities should be considered. Low-frequency electrical muscle stimulation of the quadriceps is well tolerated and may improve functional capacity in clinical populations.
The trial is a longitudinal, randomised controlled trial. Participants will be randomly allocated to 10 weeks of 1) intra-dialytic low-frequency electrical muscle stimulation, 2) intra-dialytic cycling, or 3) usual care haemodialysis without exercise training. Outcomes will be assessed at baseline and 10 weeks by assessors blinded to group allocation.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On haemodialysis for at least 3months
- •On 3 times 4 hours of dialysis per week
- •Urea reduction rate of at least 65% during the three months before enrolment
- •Age 18 years or older
- •Able to complete the exercise test and exercise training
- •Able to provide informed consent
- •Life expectancy of more than 6 months according to clinical assessment
排除标准
- •Clinically significant valvular insufficiency
- •Clinically significant dysrythmia
- •Uncontrolled blood pressure: systolic > 160, diastolic >95 during the months before enrolment
- •Excessive fluid accumulation between dialysis sessions (>3 liters), more than twice pulmonary edema over 3 months before enrolment deemed to be due to excess fluid intake
- •Haemoglobin unstable and below 9.0
- •Ischemic cardiac event or intervention in the last 3 months
- •Clinically significant, still active inflammatory or malignant process
- •Pacemaker or cardiac device (contraindicated for bioelectrical impedance)
- •Planned kidney transplant during study period.
结局指标
主要结局
Peak oxygen uptake (VO2peak)
时间窗: Baseline, 10 weeks
Cardiopulmonary exercise test
次要结局
- Muscular strength(Baseline, 10 weeks)
- Arterial remodelling(Baseline, 10 weeks)
- Health related quality of life(Baseline, 10 weeks)
- Cardiac remodelling(Baseline, 10 weeks)