Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
研究概览
简要总结
Dialysis patients usually have peripheral muscle weakness due to metabolic disturbances (increased protein catabolism) and fatigue. This muscle weakness may decrease functional capacity and quality of life. It also serves to increase cardiovascular risk factors in these end stage renal disease patients. Peripheral muscle strength training shall combat physical inactivity during dialysis. In the investigators trial, the investigators hypothesis that peripheral muscle training might regulate protein catabolic rate,renal functions, cardiovascular risk factors, improve functional capacity and quality of life in endstage renal disease patients undergoing dialysis.
详细描述
End stage renal failure patients undergoing dialysis have profound muscle wasting, reduced functional capacity and quality of life due to uremia, steroids, frequent dialysis and fatigue. During dialysis, physical inactivity further deteriorates the patient's functional capacity. Aerobic or strength training may combat this physical inactivity. It may also improve the functional capacity and quality of life. Recent studies have claimed the benefits of resistance exercises in improving functional capacity. But they have not documented effects on kidney function (electrolyte and urea kinetics) and muscle wasting (protein catabolic rate). In our trial, we attempt to study the effects of resistance training in improvement of renal function and muscle wasting apart from functional capacity and quality of life in dialysis patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have end stage renal disease (diagnosed and the stage graded by nephrologist or the intensivist concerned) for more than 6 months and dialysis for at least 3 months (the impact of exercise training can be easily assessed)
- •Must be between the ages of 30 - 60 years of age/ both genders.
- •Must be able to understand the purpose of exercise testing and resistance training.
排除标准
- •Those with acute nephritic syndrome and hematuria < 2 months.
- •Those with profound anemia and blood transfusion < 2 months
- •Those underwent renal transplantation < 6 months.
- •Those receiving/ received cytotoxic drugs - amiloride, azathioprine/ aspirin (antiplatelets)< 2 months
- •Those with coagulation disorders or under anticoagulants < 4 months.
- •Those underwent recent cardiac surgeries and with recent unstable cardiac failures
- •Those with recent cerebrovascular accidents < 6 months
- •Those have recent urinary tract infections, Renal and bladder carcinomas < 2 months
- •Those with absolute contraindications for resistance exercise training (as per American College of Sports Medicine.
结局指标
主要结局
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
时间窗: Bimonthly
次要结局
- Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test(Once Monthly)
- Fat levels by skin fold measurements(Once monthly)
- Handgrip strength by dynamometer(Once monthly)
- Six minute walk test distance(Once monthly)
- Quality of life (KDQOL - SF questionnaire)(Once monthly)
- Depression (Beck Depression Questionnaire)(Once monthly)
- Lactate Threshold(Once monthly)
研究者
Mr. Baskaran Chandrasekaran
Senior Physiotherapist
Sikkim Manipal University