Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Sikkim Manipal University
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
Time Frame: Bimonthly
Secondary Outcomes
- 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)
Investigators
Mr. Baskaran Chandrasekaran
Senior Physiotherapist
Sikkim Manipal University