Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000019202
Ethics application status
Not yet submitted
Date submitted
21/11/2008
Date registered
9/01/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of lifestyle intervention on Chronic Kidney Disease Skeletal Muscle - Landmark III Muscle Sub Study
Scientific title
Effect of lifestyle intervention on Chronic Kidney Disease Skeletal Muscle
Secondary ID [1] 748 0
Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12608000337370
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 3970 0
Condition category
Condition code
Renal and Urogenital 4167 4167 0 0
Kidney disease
Renal and Urogenital 4206 4206 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lifestyle intervention aimed at reducing cardiovascular risk in patients with Chronic Kidney Disease. The intervention will involve a supervised exercise program for a period of 8 weeks, in addition too dietary advice as well as access to other allied health providers as required. The patients will continue to receive ongoing support beyond the initial exercise and dietary components in line with the Landmark III protocol. The participants will attend the gym for a supervised exercise session by an accredited exercise physiologist, up to three times per week. Each session will last for approximately 60 minutes and will be of moderate intensity exercise. Participants will complete both aerobic and resistance exercise during each session, as well as stretching, warm up and cool down. The participants will undergo four group dietary and lifestyle sessions with a Dietician and Psychologist. The dietary and lifestyle sessions will assist the participants in identifying areas of their diet or lifestyle that may require change to assist the participants in achieving targets and improving their health. The group sessions will run during the eight week exercise period, with the participants attending one group session per week.
Participants will undergo two muscle samples at baseline and 8 weeks. On completion of this initial assessment of muscle tissue, participants will continue as per the standard study protocol for the Landmark III study. Therefore the patient group receiving standard care will continue as per the study protocol and the group receiving the lifestyle intervention will continue to receive ongoing support.
Intervention code [1] 3688 0
Lifestyle
Comparator / control treatment
The control group will receive standard nephrological care as provided currently by their General Practitioner and Specialists.
Control group
Active

Outcomes
Primary outcome [1] 5061 0
Skeletal Muscle Biopsy - protein and gene markers
Timepoint [1] 5061 0
Baseline and 8-12 weeks
Secondary outcome [1] 8570 0
Change in body mass will be assessed by measuring weight, waist circumference and body mass index (BMI). These measures will be taken by an investigator involved in the Landmark III trial.
Timepoint [1] 8570 0
baseline and 8 weeks

Eligibility
Key inclusion criteria
- Stage 3 to 4 Kidney Disease (estimated Glomerular Filtration Rate <60ml/min and 25ml/min)
- aged 18-75 years
- at least one of the following risk factors - blood pressure not at target, Overweight (Body Mass Index >25); Poor diabetic control; or Lipids not at target
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable or unwilling to give informed consent
- eGFR<25ml/min
- Pregnant
- Life expectancy less than 6 months
- Current involvement in other research study
Organ transplant

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 will be identified through the Renal Unit at the Princess Alexandria Hospital. Participants will be randomised to participate in the Landmark III study using the minimisation method, which will be stratified for eGFR and diabetes. Participants who are recruited for the sub study will be approached once they have been randomised to a trial group to participate in the sub study. All participants will be approached about the study until the required study numbers are met.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The minimisation method is being used to randomised patients to groups as part of the Landmark III study participants will then be approached to participate in the sub study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1305 0
4102

Funding & Sponsors
Funding source category [1] 4195 0
University
Name [1] 4195 0
The School of Human Movement Studies, The University of Queensland.
Country [1] 4195 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jeff Coombes
Address
Level 5, Human Movement Studies Building (26b), Blair Drive, St Lucia Campus
The University of Queensland,
St Lucia, QLD, 4072
Country
Australia
Secondary sponsor category [1] 3769 0
Individual
Name [1] 3769 0
Dr Nikky Isbel
Address [1] 3769 0
Department of Renal Medicine, Princess Alexandra Hospital, 199 Ipswich Road
Wooloongabba, QLD 4102
Country [1] 3769 0
Australia
Other collaborator category [1] 488 0
Individual
Name [1] 488 0
Ms Erin Howden
Address [1] 488 0
Level 5, Human Movement Studies Building (26b), Blair Drive, St Lucia Campus
The University of Queensland,
St Lucia, QLD, 4072
Country [1] 488 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6252 0
Princess Alexandra Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 6252 0
Centres for Health Research
Level 2, Building 35
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba, QLD, 4102
Ethics committee country [1] 6252 0
Australia
Date submitted for ethics approval [1] 6252 0
17/11/2008
Approval date [1] 6252 0
Ethics approval number [1] 6252 0
2008/265

Summary
Brief summary
Chronic kidney disease (CKD) patients experience skeletal muscle wasting and this leads to decreased functional capacity and quality of life. A lifestyle intervention consisting of exercise and dietary advice is known to slow muscle wasting in older individuals however the effects in CKD patients is unknown. Furthermore, the mechanisms underlying these potential effects are not well understood. The aim of this study is to investigate the effects of an 8 week lifestyle intervention containing supervised exercise and dietary advice will effect markers of skeletal muscle structure and function in patients with chronic kidney disease. Patients will be recruited as part of the Landmark III study that is currently underway at the Princess Alexandra Hospital, Brisbane Australia. Following radomisation in to the larger study patients will be approached to participate in this sub study. 15 patients from each group will be recruited and undergo a muscle biopsy following baseline testing and then 12 weeks later. Muscle samples will be taken from the vastus lateralis muscle using the Bergstrom method and will be performed by a qualified medical practitioner. Muscle tissue samples will be stored in standard conditions, and analysis will be undertaken on completion of the sub study.
Trial website
nil
Trial related presentations / publications
Results from the study will be presented in scientific Nephrology and Exercise Journals, as well as Scientific conference and within a PhD thesis.
Public notes

Contacts
Principal investigator
Name 29123 0
Address 29123 0
Country 29123 0
Phone 29123 0
Fax 29123 0
Email 29123 0
Contact person for public queries
Name 12280 0
Ms Erin Howden
Address 12280 0
Level 5, Human Movement Studies Building (26b), Blair Drive, St Lucia Campus
The University of Queensland,
St Lucia, QLD, 4072
Country 12280 0
Australia
Phone 12280 0
+61 7 33656983
Fax 12280 0
Email 12280 0
[email protected]
Contact person for scientific queries
Name 3208 0
Ms Erin Howden
Address 3208 0
Level 5, Human Movement Studies Building (26b), Blair Drive, St Lucia Campus
The University of Queensland,
St Lucia, QLD, 4072
Country 3208 0
Australia
Phone 3208 0
+61 7 33656983
Fax 3208 0
Email 3208 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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Documents added automatically
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