Resistance Training in Intradialysis Patients (DIAPRE)

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease; Dialysis
• Intervention / Treatment: Behavioral: Progressive Resistance Exercise Training; Behavioral: Unstructured Nonprogressive resistance exercise

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
• Enrollment (Anticipated): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Sikkim
    • Gangtok, Sikkim, India, 737102
      • Central Referral Hospital, SMIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Non progressive strength training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): August 1, 2016

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (ESTIMATE): February 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 8, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Resistance training; VO2 max; Intradialysis; Protein Catabolic Rate; Urea kinetics
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CTRI/2010/091/000014