Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients (PRT)

January 3, 2012 updated by: Bangor University

Effects of Progressive Resistance Training During Haemodialysis on Muscle Quantity and Function in Patients With Chronic Kidney Disease

The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis.

It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life.

In other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. It is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. However, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients.

Therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney diseases stage five requiring maintenance hemodialysis.

Exclusion Criteria:

  • Patients who have been receiving dialysis for less than 3 months;
  • Are under the age of 18years;
  • Have medical contradictions to participate in the exercise programs;
  • Any uncontrolled medical condition which does not allow participation in exercise;
  • Have known neuro-muscular disorders;
  • Have any other uncontrolled medical condition, including pregnancy;
  • Are not independently ambulant for 50 m;
  • Have received anabolic intervention, or had catabolic conditions within the last 3 months;
  • Have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance;
  • Are vulnerable to heat stress;
  • Or are unable to give consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic kidney disease progressive resistance training group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Other: Progressive resistance training programme
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Other Names:
  • Intradialytic resistance exercise
Sham Comparator: Chronic kidney disease sham exercise group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Other: Sham exercise
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Experimental: Healthy controls progressive resistance training group
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Other: Progressive resistance training
Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
Sham Comparator: Healthy controls sham exercise group
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Other: Sham exercise
Lower body stretching exercise using the easiest rehabilitation elastic Theraband

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Cross Sectional Area
Time Frame: Change from baseline in cross sectional area at 12 weeks
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Change from baseline in cross sectional area at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: Change from baseline in muscle strength at 12 weeks
Bilateral knee extensor isometric strength.
Change from baseline in muscle strength at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Collaborators

Betsi Cadwaladr University Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R& D Ref no: MACDONALD 07/53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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