Resistance Training in Intradialysis Patients

End Stage Renal Disease Clinical Trial

— DIAPRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01065389
• Other study ID #: CTRI/2010/091/000014
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 4, 2010
• Last updated: September 8, 2013
• Start date: October 2010
• Est. completion date: August 2016

Study information

• Verified date: September 2013
• Source: Sikkim Manipal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: August 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dialysis
• End Stage Renal Disease
• Kidney Failure, Chronic

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
• 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.

Locations

Country	Name	City	State
India	Central Referral Hospital, SMIMS	Gangtok	Sikkim

Sponsors (1)

Lead Sponsor	Collaborator
Sikkim Manipal University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate		Bimonthly	No
Secondary	Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test		Once Monthly	No
Secondary	Fat levels by skin fold measurements		Once monthly	No
Secondary	Handgrip strength by dynamometer		Once monthly	No
Secondary	Six minute walk test distance		Once monthly	No
Secondary	Quality of life (KDQOL - SF questionnaire)		Once monthly	No
Secondary	Depression (Beck Depression Questionnaire)		Once monthly	No
Secondary	Lactate Threshold		Once monthly	No