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Trial registered on ANZCTR


Registration number
ACTRN12614000625673
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
13/06/2014
Date last updated
15/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
A randomised controlled trial comparing the benefits of once to twice weekly supervised aerobic cycling exercise on functional fitness and quality of life in haemodialysis patients.
Secondary ID [1] 284611 0
Nil
Universal Trial Number (UTN)
U1111-1156-8944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 291917 0
Condition category
Condition code
Renal and Urogenital 292269 292269 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3-month exercise intervention will be undertaken by all recruited participants. Group Aex will receive supervision of an exercise physiologist (EP) during the second dialysis session of each week. Participants are instructed to exercise at a rating of perceived exertion (RPE) of 13 on a Borg scale. Each exercise session will be 30-60 minutes long during the first two of dialysis treatment for that day. Progression of exercise duration over the 3 months period is expected, but will be determined by participant response to the program. Using a stationary bike that is placed in front of the client’s dialysis chair, a warm up of 5-15 minutes will be completed followed by a 10 minute rest. After the rest clients will continue with exercise at the specified intensity for (up to) 30 to 60 minutes. In line with evidence based practice, participants will be constantly monitored by the exercise physiologist who will review the exercise prescription and aim to progressively update the loading (intensity) over time as individual participant adaptation occurs. Participants will be asked to refrain from adding extra exercise activities for the course of the intervention period.
Intervention code [1] 289387 0
Rehabilitation
Comparator / control treatment
The comparator/control Group Bex, will be prescribed with the same exercise protocol except with an additional non-EP supervised exercise session every week. The dialysis nurse will provide the stationary bike for participants to exercise and confirm the exercise intensity and duration with the participants. Therefore, participants undergo 1 supervised and 1 unsupervised session per week throughout the 3 month treatment period.
Control group
Active

Outcomes
Primary outcome [1] 292134 0
Distance (m) for 6 minute walk test
Timepoint [1] 292134 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [1] 308265 0
Midweek Pre-dialysis and Post-dialysis weight

Timepoint [1] 308265 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [2] 308266 0
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.
Timepoint [2] 308266 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [3] 308268 0
Kidney Disease Quality of Life Survey Short Form 1.3 (KDQOL)
Timepoint [3] 308268 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [4] 308269 0
Pre-dialysis & post-dialysis haematological measures (potassium, creatinine, albumin, urea, phosphate)
Timepoint [4] 308269 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [5] 308327 0
Number of repetitions for 30 second sit-to-stand
Timepoint [5] 308327 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [6] 308328 0
Walking speed and agility using 8ft timed up and go.
Timepoint [6] 308328 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [7] 308329 0
Maximal leg strength using back-leg-chest dynamometer
Timepoint [7] 308329 0
Baseline and at 12 weeks after intervention commencement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects must have documented medical clearance prior to entering this research project. A medical referral form for participants in the project will be forwarded to each participant’s medical advisor for completion.

Each subject’s referral and medical history form will be screened before admission to this project, using guidelines outlined by the American College of Sports Medicine.

The participants will be randomised to either a once-weekly (Group Aex) or twice-weekly (Group Bex) cycling exercise group. Randomisation assignments were generated by an investigator who was not involved in testing or training and delivered to patients with sequentially numbered, opaque sealed envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation process using sequentially numbered, opaque sealed envelops described by Doig et al (2005) will be used.
A colleague of the investigators will prepare 2 sets of 20 opaque sealed envelops. In each envelop, a sheet of standard size paper marked with the treatment group will be folded to fit into the envelop. A sheet of carbon paper is placed on top of the folder treatment allocation paper with the carbon side facing the paper. A sheet of foil is folded over both sides of the carbon-treatment allocation paper combination before inserting into a blank envelop, with the carbon paper closest to the front of the envelop. The foil wrapper ensures that the envelop is opaque. The envelop is sealed and the person preparing the envelops will sign his name, in pen, over the top of the envelop seal. The first set of 20 is for treatment 1 (once weekly cycling) and the second set of 20 is for treatment 2 (twice weekly cycling). The two sets of envelops will then be combined and shuffle thoroughly as one would a deck of cards. Once satisfied, a unique number on the front of each envelop is marked sequentially from 1 to 40, in pen. The carbon paper inside the envelop will transfer this number to the allocation paper inside. The envelops are then placed into a container in numerical order, ready for use.

Doig, G.S. and F. Simpson, Randomization and allocation concealment: a practical guide for researchers. J Crit Care, 2005. 20(2): p. 187-91; discussion 191-3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 34 people would be needed (17 in each group) to achieve 80% power to detect an overall improvement of 35 m, assuming a 20 metre improvement in the once week group and 50 metre improvement in the twice a week group. Assuming attrition is about 10%, an increase of 3 in each group is warranted, resulting in a final sample size estimate of 40.

Hypotheses in this study are focused on overall change, rather than a difference in change between the groups. Therefore, analyses for primary outcomes will focus on the pre-post differences in measures overall. The main outcomes in this study are assumed to be continuous and normally-distributed. Therefore, dependent samples t-tests will be used to examine the overall change in 6-minute walk, quality of life and lean tissue mass after treatment. Exploratory analyses between the groups will be conducted once the primary hypotheses have been performed.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
4/07/2014
Actual
7/08/2014
Date of last participant enrolment
Anticipated
15/10/2014
Actual
3/12/2014
Date of last data collection
Anticipated
21/12/2014
Actual
12/03/2015
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2474 0
Hartley Dialysis Clinic - Brighton
Recruitment hospital [2] 2475 0
NephroCare Payneham Dialysis Clinic - Payneham
Recruitment hospital [3] 2476 0
Modbury Dialysis Clinic - Modbury
Recruitment postcode(s) [1] 8127 0
5048 - Brighton
Recruitment postcode(s) [2] 8128 0
5070 - Payneham
Recruitment postcode(s) [3] 8129 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 289254 0
Hospital
Name [1] 289254 0
Centre for Physical Activity in Ageing, Royal Adelaide Hospital
Country [1] 289254 0
Australia
Funding source category [2] 289295 0
Commercial sector/Industry
Name [2] 289295 0
Fresenius Medical Care Australia Pty Ltd
Country [2] 289295 0
Australia
Primary sponsor type
Hospital
Name
Centre for Physical Activity in Ageing, Royal Adelaide Hospital
Address
Hampstead Rehabilitation Centre
207-255 Hampstead Rd, Northfield, South Australia 5085
Country
Australia
Secondary sponsor category [1] 287965 0
Commercial sector/Industry
Name [1] 287965 0
Fresenius Medical Care Australia Pty Ltd
Address [1] 287965 0
The Renal Company
611 Lavender Street
Milsons Point
NSW 2061
Country [1] 287965 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291025 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291025 0
Level 3, Hanson Institute IMVS Building. North Terrace. Adelaide SA 5000
Ethics committee country [1] 291025 0
Australia
Date submitted for ethics approval [1] 291025 0
15/11/2013
Approval date [1] 291025 0
07/07/2014
Ethics approval number [1] 291025 0

Summary
Brief summary
The primary aim of this research project is to examine changes in health outcomes following the introduction of a single or two cycling exercise sessions a week to kidney failure patients. We hypothesise that after 12 weeks of either once or twice weekly of cycling sessions per week, health outcomes are improved.
Trial website
Trial related presentations / publications
Public notes
Physical Activity Scale for Elderly (PASE) will be used to assess that no significant increase in non-prescribed physical activity is performed.

Contacts
Principal investigator
Name 48450 0
Mr Danwin Chan
Address 48450 0
Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-255 Hampstead Rd, Northfield SA 5085
Country 48450 0
Australia
Phone 48450 0
+61882221891
Fax 48450 0
Email 48450 0
[email protected]
Contact person for public queries
Name 48451 0
Robert Barnard
Address 48451 0
Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-255 Hampstead Rd, Northfield SA 5085
Country 48451 0
Australia
Phone 48451 0
+61882221891
Fax 48451 0
Email 48451 0
[email protected]
Contact person for scientific queries
Name 48452 0
Danwin Chan
Address 48452 0
Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-255 Hampstead Rd, Northfield SA 5085
Country 48452 0
Australia
Phone 48452 0
+61882221891
Fax 48452 0
Email 48452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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