Resistance Training in Intradialysis Patients

NCT01065389 | Unknown Phase 2 DMC

• 1 other identifier: CTRI/2010/091/000014
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis; End Stage Renal Disease

Keywords

Intradialysis; Resistance training; Protein Catabolic Rate; Urea kinetics; Quality of life; VO2 max

Outcome Measures

Primary Outcomes (1)

• Serum and Urea biochemistry - electrolytes (Na, K+), serum albumin, inflammatory markers, urea kinetics, protein catabolic rate

  Bimonthly

Secondary Outcomes (7)

• 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

Study Arms (2)

Prgressive Resistance Exercise Training

EXPERIMENTAL

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

Unstructured Resistance Exercise

ACTIVE COMPARATOR

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

Interventions

Progressive Resistance Exercise Training BEHAVIORAL

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

Also known as: Strength Training

Prgressive Resistance Exercise Training

Unstructured Nonprogressive resistance exercise BEHAVIORAL

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.

Also known as: Non progressive strength training

Unstructured Resistance Exercise

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sikkim Manipal University: lead

Study Sites (1)

Central Referral Hospital, SMIMS

Gangtok, Sikkim, 737102, India

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Baskaran Chandrasekaran, MPT

  Lecturer / Consultant cardiopulmonary Physiotherapist

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Bidita Kandelwal, MD

  Head of Medicine Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 9, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2016
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

IN (1)