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Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients (PRT)

This study has been completed.
Sponsor:
Collaborator:
Betsi Cadwaladr University Health Board
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01007838
First received: October 15, 2009
Last updated: January 3, 2012
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
 Other: Progressive resistance training programme
Other: Sham exercise
Other: Progressive resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Progressive Resistance Training During Haemodialysis on Muscle Quantity and Function in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bangor University:

Primary Outcome Measures:
  • Muscle Cross Sectional Area [ Time Frame: Change from baseline in cross sectional area at 12 weeks ] [ Designated as safety issue: No ]
    Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.


Secondary Outcome Measures:
  • Muscle Strength [ Time Frame: Change from baseline in muscle strength at 12 weeks ] [ Designated as safety issue: No ]
    Bilateral knee extensor isometric strength.


Enrollment: 32
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007838

Locations
United Kingdom
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
Bangor, Gwynedd, United Kingdom, LL57 2PW
Sponsors and Collaborators
Bangor University
Betsi Cadwaladr University Health Board
Investigators
Principal Investigator: Jamie H MacDonald, PhD Bangor University
  More Information

No publications provided

Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01007838     History of Changes
Other Study ID Numbers: R& D Ref no: MACDONALD 07/53
Study First Received: October 15, 2009
Results First Received: November 24, 2011
Last Updated: January 3, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Bangor University:
Progressive Resistance Training/Exercise
Muscle wasting
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013