Resistance Training in Intradialysis Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients

Conditions
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Dialysis, End Stage Renal Disease

Intervention / Treatment
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* Behavioral: Progressive Resistance Exercise Training
* Behavioral: Unstructured Nonprogressive resistance exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prgressive Resistance Exercise Training<br>Progressive Resistance Exercise Training thrice a week for 12 weeks. For first two weeks, 60% of 5 repetition maximum, progressing at 5% of 5 repetition maximum each week reaching upto 110% of 5 Repetition maximum at the end of 12 weeks | Behavioral: Progressive Resistance Exercise Training<br>* Progressive Resistance Exercise Training thrice a week for 12 weeks. For first two weeks, 60% of 5 repetition maximum, progressing at 5% of 5 repetition maximum each week reaching upto 110% of 5 Repetition maximum at the end of 12 weeks<br>* Other names: Strength Training;|
| Active Comparator: Unstructured Resistance Exercise<br>Unstructured Resistance Exercise thrice a week for 12 weeks. For 12 weeks, 20% 5 repetition maximum (which will not induce training effect and any physiological responses)and free range of motion exercises with no progression. | Behavioral: Unstructured Nonprogressive resistance exercise<br>* Unstructured Resistance Exercise 30 minutes a day, thrice a week for 12 weeks. For 12 weeks, 20% 5 repetition maximum (which will not induce training effect and any physiological responses)and free range of motion exercises with no progression.<br>* Other names: Non progressive strength training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate |  | Bimonthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intradialysis, Resistance training, Protein Catabolic Rate, Urea kinetics, Quality of life, VO2 max