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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007838
Other study ID # R& D Ref no: MACDONALD 07/53
Secondary ID
Status Completed
Phase N/A
First received October 15, 2009
Last updated January 3, 2012
Start date January 2009
Est. completion date October 2011

Study information

Verified date December 2011
Source Bangor University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.
Sham exercise
Lower body stretching exercise using the easiest rehabilitation elastic Theraband
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 exercise
Lower body stretching exercise using the easiest rehabilitation elastic Theraband

Locations

Country Name City State
United Kingdom Renal unit, Ysbyty Gwynedd, North West Wales NHS Trust Bangor Gwynedd

Sponsors (2)

Lead Sponsor Collaborator
Bangor University Betsi Cadwaladr University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Cross Sectional Area 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 No
Secondary Muscle Strength Bilateral knee extensor isometric strength. Change from baseline in muscle strength at 12 weeks No
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