Resistance Training in Intradialysis Patients

NCT ID: NCT01065389

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-08-31

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

Conditions

Dialysis; End Stage Renal Disease

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Progressive Resistance Exercise Training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Unstructured Nonprogressive resistance exercise

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strength Training; Non progressive strength training

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sikkim Manipal University

OTHER

Sponsor Role: lead

Responsible Party

Mr. Baskaran Chandrasekaran

Senior Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baskaran Chandrasekaran, MPT

Role: PRINCIPAL_INVESTIGATOR

Lecturer / Consultant cardiopulmonary Physiotherapist

Bidhan C Sharma, MPT

Role: STUDY_CHAIR

Assistant Professor/ Consultant Physiotherapist

Manish Goon, BPT

Role: STUDY_CHAIR

Clinical Physiotherapist

Nikita Joshi, MPT

Role: STUDY_CHAIR

Head of Department/ Associate Professor

Arpan Battacharia, MD

Role: STUDY_CHAIR

Dialysis Unit Incharge

Bidita Kandelwal, MD

Role: STUDY_DIRECTOR

Head of Medicine Department

Locations

Central Referral Hospital, SMIMS

Gangtok, Sikkim, India

Countries

India

Other Identifiers

CTRI/2010/091/000014

Identifier Type: -

Identifier Source: org_study_id