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Trial registered on ANZCTR


Registration number
ACTRN12610000941066
Ethics application status
Approved
Date submitted
3/11/2010
Date registered
4/11/2010
Date last updated
12/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Clinical Exercise Physiology Interventions on Physical Activity, Quality of Life and Clinical Prognosis in Type II Diabetes
Scientific title
Effectiveness of Clinical Exercise Physiology Interventions on Physical Activity, Quality of Life and Clinical Prognosis in Type II Diabetes
Secondary ID [1] 253015 0
H11326 UTas Ethics ID
Universal Trial Number (UTN)
U1111-1117-6788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II Diabetes 258567 0
Condition category
Condition code
Metabolic and Endocrine 258708 258708 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive Exercise Physiology Intervention.
Each case will be classified retrospectively into the intensive or low intensity group. The classification will be based on the number and length of sessions the participant spends with an Exercise Physiologist. The intensive group will consist of those participants who spend a total of hours with the exercise physiologist greater than the mean for the entire sample population over the intervention period.
Intervention code [1] 257539 0
Other interventions
Intervention code [2] 257548 0
Lifestyle
Comparator / control treatment
Low Intensity Exercise Physiology Intervention. The low intensity group will consist of those participants who spend a total of hours with the exercise physiologist less than the mean for the entire sample population over the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 259571 0
Changes in the concentration of glycated haemoglobin (HbA1c) indicating changes in plasma glucose over time will be assessed through regular pathology testing initiated by referring general practitioners. Patients will be asked to bring their most recent pathology results to each assessment session
Timepoint [1] 259571 0
baseline and at 6 months
Primary outcome [2] 259572 0
Physical Function - six minute walk test
Timepoint [2] 259572 0
baseline and at 6 months
Primary outcome [3] 259584 0
Level of self reported physical activity using the Active Australia Questionnaire.
Timepoint [3] 259584 0
baseline and at 6 months
Secondary outcome [1] 266192 0
Self reported physical function - Medical Outcomes Short-Form 36-Item Health Survey (SF-36)
Timepoint [1] 266192 0
baseline and at 6 months
Secondary outcome [2] 266193 0
Blood Pressure
Brachial blood pressure will be measured by sphygmomanometry using standardised techniques after five minutes of seated rest.
Timepoint [2] 266193 0
baseline and at 6 months
Secondary outcome [3] 266194 0
Body Composition
Two indicators of body composition will be measured. These are body mass index and waist circumference.
Timepoint [3] 266194 0
baseline and at 6 months

Eligibility
Key inclusion criteria
Patients with diagnosed type II diabetes who have been referred for lifestyle counselling with an exercise physiologist by their general practitioner
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients for whom exercise is contraindicated (medically unstable conditions - eg. unstable angina).

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)
All participants will be enrolled according to the same criteria: suffering type II diabetes and referral from general practitioners for Exercise Physiology couselling provided by one of the two exercise physiology clinics participating in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non randomised trial, the assignment to group will be retrospective according to the intensity (number of sessions with an exercise physiologist as defined in GP referral).
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
Suspended
Date of first participant enrolment
Anticipated
3/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3408 0
7250
Recruitment postcode(s) [2] 3409 0
4178

Funding & Sponsors
Funding source category [1] 257995 0
Self funded/Unfunded
Name [1] 257995 0
Country [1] 257995 0
Primary sponsor type
University
Name
Andrew Williams
Address
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 257192 0
None
Name [1] 257192 0
Address [1] 257192 0
Country [1] 257192 0
Other collaborator category [1] 251639 0
Other Collaborative groups
Name [1] 251639 0
General Practice North - Travis Davies
Address [1] 251639 0
Level 5, 11 High Street
Launceston TAS 7250
Country [1] 251639 0
Australia
Other collaborator category [2] 251640 0
Commercial sector/Industry
Name [2] 251640 0
Health Balance - Chris Nunn
Address [2] 251640 0
46a Cnr Bay Terrace and Charlotte St
Wynnum QLD 4178
Country [2] 251640 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259987 0
Tasmanian Health and Medical Research Ethics Committee
Ethics committee address [1] 259987 0
Ethics committee country [1] 259987 0
Australia
Date submitted for ethics approval [1] 259987 0
Approval date [1] 259987 0
31/08/2010
Ethics approval number [1] 259987 0
H11326
Ethics committee name [2] 259988 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 259988 0
Ethics committee country [2] 259988 0
Australia
Date submitted for ethics approval [2] 259988 0
Approval date [2] 259988 0
11/10/2010
Ethics approval number [2] 259988 0
HMS10/1110

Summary
Brief summary
Exercise Physiologists are a relatively new allied health profession. The exercise physiologist provides exercise counselling with the objective being to improve various health related parameters for the client. However to date there is virtually no research available to confirm or refute the efficacy of the exercise physiologist in producing meaningful improvements in the health of an individual. A number of studies have reported exercise training leads to positive health outcomes in type II diabetes. An issue with these studies is that they are highly controlled. While this is desirable from the point of view of determining effects, it is often not reproducible in an applied setting and may not readily transform to patients continuing the exercise in a less controlled setting such as occurs in clinical practice.

The study will follow the changes in health markers in approximately 500 type II diabetics who undergo exercise physiology counselling in a clinical practice setting. A range of measures of physical function, participation in physical activity, quality of life and clinical prognosis will be measured on commencement in the study and after six months of treatment. The number of sessions with an exercise physiologist and whether or not patients received treatment with another allied health professional will be used as co-variates in the statistical analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31866 0
Dr Andrew Williams
Address 31866 0
School of Human Life Sciences University of Tasmania Locked Bag 1320 Launceston TAS 7250
Country 31866 0
Australia
Phone 31866 0
+61 3 6324 5487
Fax 31866 0
Email 31866 0
[email protected]
Contact person for public queries
Name 15113 0
Andrew Williams
Address 15113 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 15113 0
Australia
Phone 15113 0
+61 3 6324 5487
Fax 15113 0
Email 15113 0
[email protected]
Contact person for scientific queries
Name 6041 0
Andrew Williams
Address 6041 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 6041 0
Australia
Phone 6041 0
+61 3 6324 5487
Fax 6041 0
Email 6041 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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