A randomised controlled trial comparing the benefits of once to twice weekly aerobic cycling exercise on functional fitness and quality of life in haemodialysis patients.

Not Applicable

• Conditions: End Stage Renal Disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12614000625673
• Lead Sponsor: Centre for Physical Activity in Ageing, Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

For the subjects to be included into the study, they need to satisfy the following criteria:

*On maintenance haemodialysis for the past 3 months
* Community residing;
*Functionally independent;
*Ambulatory with or without regular use of an assistive device;
*Have no medical conditions or physical or cognitive limitations that would prohibit them from following instructions and participating safely in the tests;
*Not identified as having recent falls
*Medical clearance

Exclusion Criteria

Contraindications

*A recent significant change in the resting ECG suggesting infarction or other acute cardiac event
*Recent complicated myocardial infarction (unless patient is stable and angina free)
*Severe aortic stenosis
*Suspected or known dissecting aneurism
*Active myocarditis or pericarditis
*Thrombophlebitis or intracardiac thrombi
*Recent systemic or pulmonary embolus
*Acute infections
*Significant emotional distress (psychosis)
*Resting diastolic blood pressure > 115 mm Hg or resting systolic blood pressure >200 mm Hg
*Moderate valvular heart disease
*Fixed rate pacemaker (rarely used)
*Frequent or complex ventricular ectopy
*Ventricular aneurism
*Uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis or myxedema)
*Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise
*Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance (m) for 6 minute walk test<br>[Baseline and at 12 weeks after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
umber of repetitions for 30 second sit-to-stand[Baseline and at 12 weeks after intervention commencement];Walking speed and agility using 8ft timed up and go. <br>[Baseline and at 12 weeks after intervention commencement];Midweek Pre-dialysis and Post-dialysis weight <br><br>[Baseline and at 12 weeks after intervention commencement];Lean tissue mass, adipose tissue mass and overhydration will be measured using the Body Composition Monitor (Fresenius Medical Care) which is a bio-impedance spectroscopy device. <br>[Baseline and at 12 weeks after intervention commencement];Kidney Disease Quality of Life Survey Short Form 1.3 (KDQOL)<br><br>[Baseline and at 12 weeks after intervention commencement];Pre-dialysis & post-dialysis haematological measures (potassium, creatinine, albumin, urea, phosphate) [Baseline and at 12 weeks after intervention commencement];Maximal leg strength using back-leg-chest dynamometer [Baseline and at 12 weeks after intervention commencement]