Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000496819
Ethics application status
Approved
Date submitted
7/05/2012
Date registered
8/05/2012
Date last updated
27/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Can thrice a week of resistance training during dialysis improve cardiovascular health and other outcomes in patients with kidney failure?
Scientific title
A within-subject crossover clinical trial to investigate the effectiveness of 12 weeks intradialytic progressive resistance exercise program performed thrice a week in improving the arterial stiffness and other clinical outcomes of haemodialysis patients.
Secondary ID [1] 280438 0
Nil
Universal Trial Number (UTN)
U1111-1130-4309
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage renal disease 286411 0
Condition category
Condition code
Renal and Urogenital 286661 286661 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resistance exercise intervention: After 12 weeks of usual care and 1 week gap (testing period), participants proceed to 12 week intradialytic resistance training intervention conducted 3 times per week for approximately 30 minutes per session encompassing full body weight training. Moderate to high intensity, progressive resistance training (free weights, elastic tubings and machine) will be administered by an exercise physiologist. The training session will be conducted on an individual basis. A generic set of exercises will be prescribed and progressed according to individual's rating of perceived exertion.
Intervention code [1] 284801 0
Rehabilitation
Comparator / control treatment
Usual care: During the 12 weeks control period, participants will be provided usual medical and dialysis care but will be given no instructions to exercise or access to equipment.
Control group
Active

Outcomes
Primary outcome [1] 287069 0
A marker of arterial stiffness, brachial-ankle pulse wave velocity (metre per second) will be measured by applanation tonometry using the SphygmoCor System and Program (AtCor Medical Pty, Sydney, Australia)
Timepoint [1] 287069 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Primary outcome [2] 287070 0
A marker of arterial stiffness, augmentation index (unit) will be measured by applanation tonometry using the SphygmoCor System and Program (AtCor Medical Pty, Sydney, Australia)
Timepoint [2] 287070 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [1] 297309 0
Haematological markers: full blood count, endothelial progenitor cells, C-reactive protein, blood lipids.
Timepoint [1] 297309 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [2] 297310 0
Muscular strength: To assess upper body strength, maximal handgrip strength of each arm using a handgrip dynamometer is measured. The highest score out of 3 trials will be measured. To assess lower body strength, 10 repetition maximum (the heaviest weight that can be lifted for only 10 repetitions) of each of the knee extensor and knee flexor will be measured.
Timepoint [2] 297310 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [3] 297311 0
Physical function assessed by the six minute walk test. Maximum distance walked in six minutes along a circuit is measured.
Timepoint [3] 297311 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [4] 297312 0
Depression level assessed by Geriatric Depression Scale (GDS), with scores more than 9/30 considered as possible depression.
Timepoint [4] 297312 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [5] 297313 0
Medical Outcomes Trust Short-Form 36 will be used to evaluate changes in eight domains of health-related quality of life, including physical functioning.
Timepoint [5] 297313 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)
Secondary outcome [6] 297314 0
Anthropometric measures: Weight is measured using a weight scale and waist circumference is measured using a non-metallic tape measure with a spring-load handle.
Timepoint [6] 297314 0
Baseline (Week 0), Post-usual care (Week 13) and Post-intervention (Week 26)

Eligibility
Key inclusion criteria
haemodialysis patients aged greater than or equal to 40 years

medically stable, and adequately dialysed (Kt/V greater than or equal to 1.2) for greater than three months

ability to ambulate independently or with an assistive device for more than or equal to 50m

cognition and English language sufficient to understand research procedures and provide written informed consent

sedentary (i.e. less than 120 minutes of moderate intensity physical activity per week)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
limb amputation, acute or chronic medical condition that contraindicates or prevents the performance of resistance training during hemodialysis treatment,

current participation in an exercise regimen involving resistance training.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
2/08/2012
Date of last participant enrolment
Anticipated
15/06/2013
Actual
7/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285205 0
University
Name [1] 285205 0
University of Western Sydney
Country [1] 285205 0
Australia
Primary sponsor type
Individual
Name
Danwin Chan
Address
4/189 Churchill Rd
Prospect
SA 5082
Country
Australia
Secondary sponsor category [1] 284077 0
Individual
Name [1] 284077 0
Dr Bobby Cheema
Address [1] 284077 0
Dr Bobby Cheema
Senior Lecturer of Sport & Exercise Science
School of Science and Health
University of Western Sydney Locked Bag 1797, Penrith South DC, NSW 2751
Country [1] 284077 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287203 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 287203 0
Level 3, Hanson Institute
IMVS Building
North Terrace
Adelaide SA 5000
Ethics committee country [1] 287203 0
Australia
Date submitted for ethics approval [1] 287203 0
01/05/2012
Approval date [1] 287203 0
04/05/2012
Ethics approval number [1] 287203 0
Ethics committee name [2] 287204 0
UWS HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [2] 287204 0
Office of Research Services
Building K, Penrith Campus
University of Western Sydney
Locked Bag 1797
Penrith, 2751
NSW, Australia
Ethics committee country [2] 287204 0
Australia
Date submitted for ethics approval [2] 287204 0
03/05/2012
Approval date [2] 287204 0
Ethics approval number [2] 287204 0

Summary
Brief summary
Cardiovascular mortality and morbidity are high in end-stage renal disease (ESRD) patients compared to general population. Arterial stiffness is a cardiovascular measure that predicts mortality in ESRD patients. Although exercise can counteract many risk factors contributing to arterial stiffness, research on its effect on arterial stiffness in ESRD patients is inconclusive and limited to aerobic exercise. The aim of this project is to examine the affect of intradialytic resistance training on arterial stiffness and other secondary health outcomes in ESRD patients. Participants will undergo a 12 weeks usual care control period followed by a 12 weeks resistance training intervention period. Participants will be recruited from dialysis centres and will undertake their exercises in their centres. All participants will undergo a series of measurements before and after control period and after intervention period. Measures include arterial stiffness, blood sample measures, quality of life, depression level, physical fitness and activity level.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34139 0
Mr Danwin Chan
Address 34139 0
Centre for Physical Activity in Ageing 207-255 Hampstead Rd Northfield SA 5085
Country 34139 0
Australia
Phone 34139 0
+61 402819342
Fax 34139 0
Email 34139 0
[email protected]
Contact person for public queries
Name 17386 0
Mr Danwin Chan
Address 17386 0
Danwin Chan
Centre for Physical Activity in Ageing
207-255 Hampstead Rd
Northfield SA 5085
Country 17386 0
Australia
Phone 17386 0
+61 402819342
Fax 17386 0
Email 17386 0
[email protected]
Contact person for scientific queries
Name 8314 0
Mr Danwin Chan
Address 8314 0
Danwin Chan
Centre for Physical Activity in Ageing
207-255 Hampstead Rd
Northfield SA 5085
Country 8314 0
Australia
Phone 8314 0
+61 402819342
Fax 8314 0
Email 8314 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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