Resistance Training in Intradialysis Patients (DIAPRE)

• ClinicalTrials.gov Identifier: NCT01065389
• Recruitment Status: Unknown
• First Posted: February 9, 2010
• Last Update Posted: September 10, 2013
• Sponsor: Sikkim Manipal University
• Information provided by (Responsible Party): Mr. Baskaran Chandrasekaran, Sikkim Manipal University

Tracking Information

• First Submitted Date: February 4, 2010
• First Posted Date: February 9, 2010
• Last Update Posted Date: September 10, 2013
• Study Start Date: October 2010
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 8, 2010): Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate [ Time Frame: Bimonthly ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01065389 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 8, 2010)

• Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test [ Time Frame: Once Monthly ]
• Fat levels by skin fold measurements [ Time Frame: Once monthly ]
• Handgrip strength by dynamometer [ Time Frame: Once monthly ]
• Six minute walk test distance [ Time Frame: Once monthly ]
• Quality of life (KDQOL - SF questionnaire) [ Time Frame: Once monthly ]
• Depression (Beck Depression Questionnaire) [ Time Frame: Once monthly ]
• Lactate Threshold [ Time Frame: Once monthly ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Resistance Training in Intradialysis Patients
• Official Title: Phase 1 RCT of Progressive Resistance Training on Small Solute Clearance, Functional Capacity and Quality of Life in Intradialysis Patients
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Dialysis
• End Stage Renal Disease

Intervention

• 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
• 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

Study Arms

• 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
  Intervention: Behavioral: Progressive Resistance Exercise 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.
  Intervention: Behavioral: Unstructured Nonprogressive resistance exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 8, 2010): 46
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2016
• Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01065389
• Other Study ID Numbers: CTRI/2010/091/000014
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mr. Baskaran Chandrasekaran, Sikkim Manipal University
• Study Sponsor: Sikkim Manipal University
• Collaborators: Not Provided

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

• PRS Account: Sikkim Manipal University
• Verification Date: September 2013