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Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients (PRT)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Progressive resistance training programme
Sham exercise
Progressive resistance training
Sham exercise
Sponsored by
Bangor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Progressive Resistance Training/Exercise, Muscle wasting, Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Chronic kidney disease progressive resistance training group

Chronic kidney disease sham exercise group

Healthy controls progressive resistance training group

Healthy controls sham exercise group

Arm Description

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.

Lower body stretching exercise using the easiest rehabilitation elastic Theraband

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.

Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Outcomes

Primary Outcome Measures

Muscle Cross Sectional Area
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
Bilateral knee extensor isometric strength.

Full Information

First Posted
October 15, 2009
Last Updated
January 3, 2012
Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board
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1. Study Identification

Unique Protocol Identification Number
NCT01007838
Brief Title
Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients
Acronym
PRT
Official Title
Effects of Progressive Resistance Training During Haemodialysis on Muscle Quantity and Function in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Progressive Resistance Training/Exercise, Muscle wasting, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic kidney disease progressive resistance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic kidney disease sham exercise group
Arm Type
Sham Comparator
Arm Description
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Arm Title
Healthy controls progressive resistance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls sham exercise group
Arm Type
Sham Comparator
Arm Description
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Intervention Type
Other
Intervention Name(s)
Progressive resistance training programme
Other Intervention Name(s)
Intradialytic resistance exercise
Intervention Description
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 Type
Other
Intervention Name(s)
Sham exercise
Intervention Description
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Intervention Description
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 Type
Other
Intervention Name(s)
Sham exercise
Intervention Description
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
Primary Outcome Measure Information:
Title
Muscle Cross Sectional Area
Description
Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.
Time Frame
Change from baseline in cross sectional area at 12 weeks
Secondary Outcome Measure Information:
Title
Muscle Strength
Description
Bilateral knee extensor isometric strength.
Time Frame
Change from baseline in muscle strength at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie H MacDonald, PhD
Organizational Affiliation
Bangor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust
City
Bangor
State/Province
Gwynedd
ZIP/Postal Code
LL57 2PW
Country
United Kingdom

12. IPD Sharing Statement

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Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients

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