Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000268842
Ethics application status
Not yet submitted
Date submitted
23/02/2012
Date registered
6/03/2012
Date last updated
6/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of perceptually-regulated exercise training on fitness
Scientific title
The effect of perceptually-regulated exercise training in previously sedentary adults on aerobic fitness
Secondary ID [1] 280024 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour: classified as failing to achieve guidelines of 30 min moderate activity 5 days a week 285936 0
Condition category
Condition code
Cardiovascular 286125 286125 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 286130 286130 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Perceptually-regulated exercise training on a treadmill. Exercise intensity will be supervised at and perceptually-regualted at a rating of percieved exertion (RPE) 13, for 8 weeks, three times a week for 30 min. Training will be in groups of up to 5.
Arm 2: Perceptually-regulated exercise training on a treadmill. Exercise intensity will be supervised to be at RPE 15, for 8 weeks, three times a week for 30 min. Training will be in groups of up to 5.
Arm 3: No treatment control. Participants will continue their typical behaviour
Intervention code [1] 284344 0
Behaviour
Intervention code [2] 284349 0
Treatment: Other
Intervention code [3] 284350 0
Lifestyle
Comparator / control treatment
No treatment (Arm 3)
Control group
Active

Outcomes
Primary outcome [1] 286601 0
maximal aerobic capacity assessed with breath by breath on- line gas analysis during a graded treadmill exercise test. Participants will perform a graded exercise test. Treadmill speed will be fixed at 5.3 km/hr with the gradient commencing at 0% for the first minute and increased by 1%/min thereafter. The test will terminate when there is 1) a plateau in oxygen consumption; 2) a heart rate within 10 beats / min of age-predicted maximum; and 3) an RER of 1.15.
Timepoint [1] 286601 0
baseline, 8 weeks, 6 months post-training
Secondary outcome [1] 296240 0
Motivational processes will be assessed with the use of self-report questionnaires: Markland and Tobin's (2003) Behavioural Regulation in Exercise Questionnaire-2; McAuley et al's (1991) Intrinsic Motivation Inventory: Competence and Interest-enjoyment items; and Markand and Hardy's (1997) locus of causality for exercise scale.
Timepoint [1] 296240 0
baseline, 8 weeks, 6 months
Secondary outcome [2] 296241 0
Affect using Hardy and Rejeski's (1989) Feeling Scale and Thayer's (1989) Activation Deactivation Adjective Checklist
Timepoint [2] 296241 0
week 1 training, week 4 training, week 8 training
Secondary outcome [3] 296242 0
Cholesterol: A small sample of capillary blood collected from a finger prick will be applied to a disposable test strip and used to measure total cholesterol via a hand-held, portable blood analyzer (Cardiochek P.A. & PTS PANELS test strips, Polymer Technology systems Inc., Indianapolis, USA).
Timepoint [3] 296242 0
baseline, 8 weeks, 6 months post-training
Secondary outcome [4] 296259 0
Mean arterial pressure: Blood pressure will be measured using an automatic blood pressure monitor (UA-767, A&D Company, Ltd, Tokyo, Japan) following the manufacturers guidelines. After a 10 minute period of sitting on a hardback chair with both feet on the floor and their left arm supported at heart level, the air hose of the arm cuff will be aligned with the brachial artery at a point 2-3 cm above the elbow. The mean arterial blood pressure, from two separate measures (with a minimum of 10-min between each measure) will be calculated.
Timepoint [4] 296259 0
baseline, 8 weeks, 6 months post-training

Eligibility
Key inclusion criteria
currently sedentary <2 cardiovascular risk factors.
If participants report >2 risk factors (e.g. currently sedentary, smoker, male > 44 yrs) GP or appropriate Allied Health Professional to confirm safe to exercise.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
>2 cardiovascular risk factors and no GP or Allied Health Profession consent for exercise

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5026 0
5000
Recruitment postcode(s) [2] 5027 0
5001
Recruitment postcode(s) [3] 5028 0
5002

Funding & Sponsors
Funding source category [1] 284779 0
University
Name [1] 284779 0
University of South Australia
Country [1] 284779 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Division of Health Sciences
City East Campus
Centernary Building
Adelaide
SA
5001
Country
Australia
Secondary sponsor category [1] 283666 0
None
Name [1] 283666 0
Address [1] 283666 0
Country [1] 283666 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286771 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 286771 0
Ethics committee country [1] 286771 0
Australia
Date submitted for ethics approval [1] 286771 0
05/01/2012
Approval date [1] 286771 0
Ethics approval number [1] 286771 0

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

Contacts
Principal investigator
Name 33831 0
Address 33831 0
Country 33831 0
Phone 33831 0
Fax 33831 0
Email 33831 0
Contact person for public queries
Name 17078 0
Associate Professor Gaynor Parfitt
Address 17078 0
UniSA
School of Health Sciences
City East Campus
Centenary Building
Adelaide
SA
5001
Country 17078 0
Australia
Phone 17078 0
+61 8 8302 1212
Fax 17078 0
Email 17078 0
[email protected]
Contact person for scientific queries
Name 8006 0
Associate Professor Gaynor Parfitt
Address 8006 0
UniSA
School of Health Sciences
City East Campus
Centenary Building
Adelaide
SA
5001
Country 8006 0
Australia
Phone 8006 0
+61 8 8302 1212
Fax 8006 0
Email 8006 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.