Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001223921
Ethics application status
Not yet submitted
Date submitted
23/11/2011
Date registered
29/11/2011
Date last updated
29/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of different exercise intensities in chronic kidney disease
Scientific title
Effect of high intensity interval training on exercise capacity in patients with chronic kidney disease
Secondary ID [1] 273452 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage 3 & 4 chronic kidney disease 279248 0
Condition category
Condition code
Renal and Urogenital 279451 279451 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1- high intensity interval training
Arm 2- moderate intensity continuous training
Arm 3- control group

Intervention: The study will consist of 3 groups- 2 exercise interventions and a control group. Supervised by an accredited Exercise Physiologist, the 2 exercise interventions of high intensity interval training (HIIT) and moderate continuous training (MCT) will be completed over 12 weeks. The control group will undergo usual medical practitioner care. The exercise intervention groups will complete 3 supervised training sessions per week.

The two exercise interventions will be iso-caloric meaning that the MCT group will train for longer during each session. Exercise intensities will be monitored using heart rate monitors and the peak heart rate (PHR) that will be obtained during the exercise stress test.

Exercise Intensities:
HIIT: 1:00 minute intervals (90-95%), 1:00 minute active recovery (60-70% PHR)
MCT: ~40 minutes continuous exercise (60-70% PHR)

Exercise Modalities: The modality of the equipment utilized in the exercise intervention will differ each session between 3 pieces of equipment. These will include treadmill walking/running, rowing and cycle ergometer. The high intensity interval will involve walking up a hill or running on the treadmill (depending on the persons capabilities), or changing the resistance or speed on the rower and bike.
Intervention code [1] 283778 0
Lifestyle
Comparator / control treatment
The control group will recieve standard treatment as provided currently by their General Practitioners and Specialists. The usual Nephrologist treatment consists of clinical care (treating kidney function, blood pressure, diabetes etc.), regular blood tests and urine analysis
Control group
Active

Outcomes
Primary outcome [1] 286013 0
Exercise capacity measured by maximal oxygen uptake (VO2 peak)
Timepoint [1] 286013 0
Baseline and post-intervention (3 months)
Secondary outcome [1] 294974 0
Cardiovascular risk factors as measured by arterial stiffness and central blood pressure
Timepoint [1] 294974 0
Baseline and post-intervention (3 months)
Secondary outcome [2] 294975 0
Muscle atrophy and catabolic pathways measured by muscle biopsy
Timepoint [2] 294975 0
Baseline and post-intervention (3 months)

Eligibility
Key inclusion criteria
Inclusion criteria:
Completion of Landmark 3 study
Aged 18-75
Stage 3 or 4 chronic kidney disease (eGFR >25ml/min or <60ml/min)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Unable or unwilling to give informed consent
Pregnant
Life expectancy less than 6 months
Current involvement in other research studies
Organ transplant
History of significant coronary artery disease

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)
Participants who meet the eligibility criteria will be randomized into one of 3 groups: 1) high intensity interval training, 2) moderate continuous training or 3) control (1:1:1). Groups will be stratified for kidney function. Opaque sealed envelopes will be used to conceal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomistaion will be conducted by a statistician not associated with the trial using a computer program to generate the random sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284257 0
Government body
Name [1] 284257 0
National Health and Medical Research council (NHMRC) Centre for Clinical Research Excellence (CCRE) in Cardiovascular, Metabolic and Renal Diseases.
Country [1] 284257 0
Australia
Primary sponsor type
University
Name
School of Human Movement Studies, University of Queensland
Address
University of Queensland
Rm. 535 Connell Building
St Lucia, 4072
QLD, Australia
Country
Australia
Secondary sponsor category [1] 269209 0
None
Name [1] 269209 0
Address [1] 269209 0
Country [1] 269209 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286219 0
Ethics committee address [1] 286219 0
Ethics committee country [1] 286219 0
Date submitted for ethics approval [1] 286219 0
30/11/2011
Approval date [1] 286219 0
Ethics approval number [1] 286219 0

Summary
Brief summary
Exercise therapy, in particular aerobic exercise, in the CKD population has been shown to decrease cardiovascular risk factors and subsequent CVD, however there has been little work comparing the effectiveness of different exercise prescriptions. Furthermore, patients with CKD endure significant muscle wasting which greatly impacts on their ability to complete day to day activities and their quality of life.

The primary measure will be cardiorespiratory fitness, measured as maximal oxygen uptake using expired air gas analysis during an exercise stress test.

Additionally, although previous studies in chronic disease populations have demonstrated exercise therapy to be effective in reducing muscle wastage, the intensity of the training required for maximum benefits is still equivocal. The effects of training intensity on muscle wasting will be assessed through whole body composition dual x-ray absorptiometry. As the mechanisms of the persistent loss of muscle mass observed in patients with CKD is poorly understood, this study also aims to investigate the effects of exercise training on pathways of muscle breakdown. To investigate the mechanisms, plasma samples will be collected and muscle biopsies will be performed before and after the training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33433 0
Address 33433 0
Country 33433 0
Phone 33433 0
Fax 33433 0
Email 33433 0
Contact person for public queries
Name 16680 0
Kassia Weston
Address 16680 0
Level 4 School of Medicine,
Building 1,
Princess Alexandra Hospital,
Ipswich Rd, Woolloongabba,
QLD, Australia 4102
Country 16680 0
Australia
Phone 16680 0
61 07 3176 7650
Fax 16680 0
Email 16680 0
[email protected]
Contact person for scientific queries
Name 7608 0
Professor Jeff Coombes
Address 7608 0
School of Human Movement Studies
University of Queensland
Rm. 535 Connell Building
St Lucia, 4072
QLD, Australia
Country 7608 0
Australia
Phone 7608 0
61 07 336-56767
Fax 7608 0
Email 7608 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

Documents added manually
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