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
Private Bag 92019
Auckland 1142
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
The aim of the study is to compare the outcomes of individualised exercise programmes delivered in a “mixed environment” (a mix of closely supervised exercise in a “clinic-gym”, and exercise at home) with outcomes reported in controlled trials. No specific exclusion/inclusion criteria will be imposed. ADHB physicians and therapists will use their clinical judgment to identify patients they consider to be safe to exercise and will benefit from a well-designed and supervised 26-week exercise programme. With the participants’ consent, patient names and contact details will be provided to University of Auckland (UoA) researchers who will formally invite patients to enrol in the study. Researchers will follow American College of Sports Medicine guidelines during patient assessment, exercise prescription design, and exercise training. Standard fitness, strength and flexibility assessments will be made prior to, at 4-week intervals, and following the 26-week exercise programme. Participants will not be charged for the 26-week exercise programme. Qualified UoA clinical exercise physiologists will administer the exercise programmes. Postgraduate students will assist in the planning and delivery of exercise programmes, and data collected will be included in dissertations required to fulfil the academic and practical requirements for an MSc in Clinical Exercise Physiology.
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
[email protected]
Contact person for public queries
Name 38995 0
Dr 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
[email protected]
Contact person for scientific queries
Name 38996 0
Dr 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
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.