Resistance Training in Intradialysis Patients (DIAPRE)
This study has suspended participant recruitment.
(Due to temporary funding insufficiency)
Sponsor:
Sikkim Manipal University
Information provided by:
Sikkim Manipal University
ClinicalTrials.gov Identifier:
NCT01065389
First received: February 4, 2010
Last updated: October 7, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dialysis End Stage Renal Disease |
Behavioral: Progressive Resistance Exercise Training Behavioral: Unstructured Nonprogressive resistance exercise |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients |
Resource links provided by NLM:
Further study details as provided by Sikkim Manipal University:
Primary Outcome Measures:
- Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate [ Time Frame: Bimonthly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test [ Time Frame: Once Monthly ] [ Designated as safety issue: No ]
- Fat levels by skin fold measurements [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
- Handgrip strength by dynamometer [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
- Six minute walk test distance [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
- Quality of life (KDQOL - SF questionnaire) [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
- Depression (Beck Depression Questionnaire) [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
- Lactate Threshold [ Time Frame: Once monthly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 46 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prgressive Resistance Exercise Training
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
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
Other Name: Strength Training
|
|
Active Comparator: Unstructured Resistance Exercise
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
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.
Other Name: Non progressive strength training
|
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
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065389
Locations
| India | |
| Central Referral Hospital, SMIMS | |
| Gangtok, Sikkim, India, 737102 | |
Sponsors and Collaborators
Sikkim Manipal University
Investigators
| Principal Investigator: | Baskaran Chandrasekaran, MPT | Lecturer / Consultant cardiopulmonary Physiotherapist |
| Study Chair: | Bidhan C Sharma, MPT | Assistant Professor/ Consultant Physiotherapist |
| Study Chair: | Manish Goon, BPT | Clinical Physiotherapist |
| Study Chair: | Nikita Joshi, MPT | Head of Department/ Associate Professor |
| Study Chair: | Arpan Battacharia, MD | Dialysis Unit Incharge |
| Study Director: | Bidita Kandelwal, MD | Head of Medicine Department |
More Information
No publications provided
| Responsible Party: | Baskaran Chandrasekaran, Kokilaban dhirubai Ambani Hospital |
| ClinicalTrials.gov Identifier: | NCT01065389 History of Changes |
| Other Study ID Numbers: | CTRI/2010/091/000014 |
| Study First Received: | February 4, 2010 |
| Last Updated: | October 7, 2010 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Sikkim Manipal University:
|
Intradialysis Resistance training Protein Catabolic Rate |
Urea kinetics Quality of life VO2 max |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013