Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000502831
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
9/05/2012
Date last updated
9/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise in a reduced oxygen environment on changes in body composition.
Scientific title
The effect of normobaric hypoxic training on changes in body composition, in overweight, healthy males and females aged between 18-40 years.
Secondary ID [1] 280456 0
Nil
Universal Trial Number (UTN)
U1111-1130-5836
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Changes in body composition 286434 0
Condition category
Condition code
Other 286689 286689 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Normobaric hypoxia (15% oxygen concentration).

Four weeks total, three (3) times a week, 60 min per session, at 65% maximal heart rate.

Sessions will be completed on a cycling ergometer, in a room that has the capacity to have its oxygen concentration altered.

The washout period will last one week.
Intervention code [1] 284821 0
Other interventions
Comparator / control treatment
Normobaric normoxia (21% oxygen concentration).

Four weeks total, three (3) times a week, 60 min per session, at 65% maximal heart rate.

Sessions will be completed on a cycling ergometer.
Control group
Active

Outcomes
Primary outcome [1] 287085 0
Changed body composition as measured by a reduction in total fat through Dual-Energy Xray Absiorptiometry (DEXA).
Timepoint [1] 287085 0
Three DEXA scans in total, over 10 weeks.
1. Prior to training period 1.
2. Between training periods 1 and 2.
3. After training period 2.
Secondary outcome [1] 297340 0
Nil
Timepoint [1] 297340 0
Nil

Eligibility
Key inclusion criteria
Body mass index (BMI) between 24-30
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- previous history of intolerance to exercise at altitude
- known medical conditions that the subject has been advised may compromise safe participation (high blood pressure, cardiovascular disease, history of fainting)
- Testing will be delayed if a subject has an illness 24 hrs prior to a test session or an injury that they have received medical treatment for or would limit their ability to cycle
- A testing session will be terminated if subject's percent oxygen saturation drops below 75%
- current smoker
- known asthmatic

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)
Central randomisation by computer. Staff member conducting randomisation procedure not involved in direct contact with subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be by use of randomised number procedures within Microsoft Excel. Lower numbers will be allocated to the initial treatment condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285216 0
Commercial sector/Industry
Name [1] 285216 0
Altitude Technology Solutions
Country [1] 285216 0
Australia
Primary sponsor type
Government body
Name
New South Wales Institute of Sport
Address
6B Figtree Drive
Sydney Olympic Park
NSW, 2127
Country
Australia
Secondary sponsor category [1] 284087 0
None
Name [1] 284087 0
Address [1] 284087 0
Country [1] 284087 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287219 0
Australian Institute of Sport
Ethics committee address [1] 287219 0
Ethics committee country [1] 287219 0
Australia
Date submitted for ethics approval [1] 287219 0
Approval date [1] 287219 0
24/02/2011
Ethics approval number [1] 287219 0
20110210

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

Contacts
Principal investigator
Name 34151 0
Address 34151 0
Country 34151 0
Phone 34151 0
Fax 34151 0
Email 34151 0
Contact person for public queries
Name 17398 0
Sera Dogramaci
Address 17398 0
P.O Box 476,
Sydney Markets
NSW 2129
Country 17398 0
Australia
Phone 17398 0
+612 9763 0267
Fax 17398 0
+612 9763 0250
Email 17398 0
sera.dogramaci@nswis.com.au
Contact person for scientific queries
Name 8326 0
Kenneth Graham
Address 8326 0
P.O Box 476,
Sydney Markets
NSW 2129
Country 8326 0
Australia
Phone 8326 0
+612 9763 0201
Fax 8326 0
+612 9763 0250
Email 8326 0
KENNETH.GRAHAM@NSWIS.COM.AU

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.