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Trial record 2 of 66 for:    strength | ( Map: India )

Resistance Training in Intradialysis Patients (DIAPRE)

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ClinicalTrials.gov Identifier: NCT01065389
Recruitment Status : Unknown
Verified September 2013 by Mr. Baskaran Chandrasekaran, Sikkim Manipal University.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2010
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Mr. Baskaran Chandrasekaran, Sikkim Manipal University

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 9, 2010
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01065389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance Training in Intradialysis Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dialysis
  • End Stage Renal Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 8, 2010)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01065389
Other Study ID Numbers  ICMJE CTRI/2010/091/000014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr. Baskaran Chandrasekaran, Sikkim Manipal University
Study Sponsor  ICMJE Sikkim Manipal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP