Clinical trial NCT01065389: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dialysis
End Stage Renal Disease
Keywords: Intradialysis
Resistance training
Protein Catabolic Rate
Urea kinetics
Quality of life
VO2 max
Lead sponsor: Sikkim Manipal University
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate
timeFrame: Bimonthly
Secondary outcomes:
measure: Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test
timeFrame: Once Monthly
measure: Fat levels by skin fold measurements
timeFrame: Once monthly
measure: Handgrip strength by dynamometer
timeFrame: Once monthly
measure: Six minute walk test distance
timeFrame: Once monthly
measure: Quality of life (KDQOL - SF questionnaire)
timeFrame: Once monthly
measure: Depression (Beck Depression Questionnaire)
timeFrame: Once monthly
measure: Lactate Threshold
timeFrame: Once monthly
Other outcomes:
Locations:
city: Gangtok
country: India
facility: Central Referral Hospital, SMIMS
state: Sikkim
Study officials:
affiliation: Lecturer / Consultant cardiopulmonary Physiotherapist
name: Baskaran Chandrasekaran, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor/ Consultant Physiotherapist
name: Bidhan C Sharma, MPT
role: STUDY_CHAIR
affiliation: Clinical Physiotherapist
name: Manish Goon, BPT
role: STUDY_CHAIR
affiliation: Head of Department/ Associate Professor
name: Nikita Joshi, MPT
role: STUDY_CHAIR
affiliation: Dialysis Unit Incharge
name: Arpan Battacharia, MD
role: STUDY_CHAIR
affiliation: Head of Medicine Department
name: Bidita Kandelwal, MD
role: STUDY_DIRECTOR
References: