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Resistance Training in Intradialysis Patients (DIAPRE)

Primary Purpose

Dialysis, End Stage Renal Disease

Status

Unknown status

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Progressive Resistance Exercise Training

Unstructured Nonprogressive resistance exercise

About this trial

This is an interventional supportive care trial for Dialysis focused on measuring Intradialysis, Resistance training, Protein Catabolic Rate, Urea kinetics, Quality of life, VO2 max

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Central Referral Hospital, SMIMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prgressive Resistance Exercise Training

Unstructured Resistance Exercise

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test

Fat levels by skin fold measurements

Handgrip strength by dynamometer

Six minute walk test distance

Quality of life (KDQOL - SF questionnaire)

Depression (Beck Depression Questionnaire)

Lactate Threshold

Full Information

NCT ID

NCT01065389

First Posted

February 4, 2010

Last Updated

September 8, 2013

Sponsor

Sikkim Manipal University

1. Study Identification

Unique Protocol Identification Number

NCT01065389

Brief Title

Resistance Training in Intradialysis Patients

Acronym

DIAPRE

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

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sikkim Manipal University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dialysis, End Stage Renal Disease

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prgressive Resistance Exercise Training

Arm Type

Experimental

Arm Description

Arm Title

Unstructured Resistance Exercise

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Progressive Resistance Exercise Training

Other Intervention Name(s)

Strength Training

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Unstructured Nonprogressive resistance exercise

Other Intervention Name(s)

Non progressive strength training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Bimonthly

Secondary Outcome Measure Information:

Title

Maximal Oxygen Consumption (VO2 max) and Heart Rate Recovery through Queens College step test

Time Frame

Once Monthly

Title

Fat levels by skin fold measurements

Time Frame

Once monthly

Title

Handgrip strength by dynamometer

Time Frame

Once monthly

Title

Six minute walk test distance

Time Frame

Once monthly

Title

Quality of life (KDQOL - SF questionnaire)

Time Frame

Once monthly

Title

Depression (Beck Depression Questionnaire)

Time Frame

Once monthly

Title

Lactate Threshold

Time Frame

Once monthly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: