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

October 15, 2009
January 3, 2012
January 2009
October 2011   (final data collection date for primary outcome measure)
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.
Body composition [ Time Frame: Pre and post intervention (12 weeks) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01007838 on ClinicalTrials.gov Archive Site
Muscle Strength [ Time Frame: Change from baseline in muscle strength at 12 weeks ] [ Designated as safety issue: No ]
Bilateral knee extensor isometric strength.
  • Physical function [ Time Frame: Pre and post intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: Pre and post intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Pre and post intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Pre and Post (12 weeks) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • 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
  • Other: Sham exercise
    Lower body stretching exercise using the easiest rehabilitation elastic Theraband
  • 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.
  • 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.
    Intervention: Other: Progressive resistance training programme
  • Sham Comparator: Chronic kidney disease sham exercise group
    Lower body stretching exercise using the easiest rehabilitation elastic Theraband
    Intervention: Other: Sham exercise
  • 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.
    Intervention: Other: Progressive resistance training
  • Sham Comparator: Healthy controls sham exercise group
    Lower body stretching exercise using the easiest rehabilitation elastic Theraband
    Intervention: Other: Sham exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01007838
R& D Ref no: MACDONALD 07/53
No
Bangor University
Bangor University
Betsi Cadwaladr University Health Board
Principal Investigator: Jamie H MacDonald, PhD Bangor University
Bangor University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP