Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000389707
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
10/04/2013
Date last updated
10/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the benefits of prescribed exercise in clinical populations
Scientific title
Prescribed exercise to enhance aerobic capacity and strength in clinical populations
Secondary ID [1] 282246 0
None
Universal Trial Number (UTN)
U1111-1139-8422
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 288765 0
Cardiovascular disease 288766 0
Stroke 288767 0
Parkinson's disease 288768 0
Post treatment colorectal cancer 288769 0
Post treatment breast cancer 288770 0
Fibromyalgia 288771 0
Chronic obstructive pulmonary disease 288772 0
osteoarthritis 288829 0
Immune system disorders 288831 0
Blood disorders 288832 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289124 289124 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evidence-based exercise prescription.
26-week programme.
Individualised programme and session frequency to match fitness level, disabilities and co-morbidities (likely range: 3 x per week to once per week).
Clinical-gym setting supervised by clinical exercise physiologists.
Some programmes may include a home-based exercise component when deemed safe to conduct.
Clinical exercise physiologists will monitor patient adherence via patient maintained log books and phone calls.
Intervention code [1] 286862 0
Treatment: Other
Intervention code [2] 286863 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289238 0
Pre- post-intervention change in estimated VO2 maximum from submaximal Astrand Ryhming cycle ergometer test
Timepoint [1] 289238 0
After 26 weeks of intervention
Primary outcome [2] 289239 0
SF36v2.0 health questionnaire
Timepoint [2] 289239 0
After 26 weeks of intervention
Secondary outcome [1] 302086 0
Sitting blood pressure using mercury sphygmomanometer
Timepoint [1] 302086 0
After 26 weeks of intervention
Secondary outcome [2] 302088 0
Sitting resting heart rate using heart rate monitor
Timepoint [2] 302088 0
After 26 weeks of intervention
Secondary outcome [3] 302089 0
Body mass assessed on digital scales
Timepoint [3] 302089 0
After 26 weeks of intervention
Secondary outcome [4] 302090 0
BMI and waist circumference
Timepoint [4] 302090 0
After 26 weeks of intervention

Eligibility
Key inclusion criteria
Participants must be ambulatory and physician-approved to exercise.
The following diagnoses will be included:
Chronic kidney disease, cardiovascular disease, chronic obstructive pulmonary disease, stroke, Parkinson's disease, osteoarthritis, fibromyalgia, immune and blood diseases, post-breast and -colorectal cancer treatment.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to exercise; unstable cardiovascular or pulmonary condition.

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)
Participants identified by physician or therapist and consent obtained for researchers to contact potential participant; researchers obtain informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Pre-post changes in individuals. Effect size data will be calculated from group data.
Sample size calculations from published controlled trial data indicate a sample size of at 20 (for each diagnostic cohort) will be required in order to detect a clinically significant difference in pre-post changes in the variables chosen.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4974 0
New Zealand
State/province [1] 4974 0

Funding & Sponsors
Funding source category [1] 287012 0
University
Name [1] 287012 0
University of Auckland
Country [1] 287012 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 285795 0
Hospital
Name [1] 285795 0
Auckland District Health Board
Address [1] 285795 0
Private Bag 92024
Auckland 1023
Country [1] 285795 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289052 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 289052 0
Ethics committee country [1] 289052 0
New Zealand
Date submitted for ethics approval [1] 289052 0
Approval date [1] 289052 0
21/01/2013
Ethics approval number [1] 289052 0
2013/8844

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38994 0
Dr James Stinear
Address 38994 0
Tamaki Innovation Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 38994 0
New Zealand
Phone 38994 0
+64 9 3737599 ext 82378
Fax 38994 0
Email 38994 0
j.stinear@auckland.ac.nz
Contact person for public queries
Name 38995 0
James Stinear
Address 38995 0
Tamaki Innovation Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 38995 0
New Zealand
Phone 38995 0
+64 9 3737599 ext 82378
Fax 38995 0
Email 38995 0
j.stinear@auckland.ac.nz
Contact person for scientific queries
Name 38996 0
James Stinear
Address 38996 0
Tamaki Innovation Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 38996 0
New Zealand
Phone 38996 0
+64 9 3737599 ext 82378
Fax 38996 0
Email 38996 0
j.stinear@auckland.ac.nz

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.