Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001406493
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
10/10/2016
Date last updated
11/02/2019
Date data sharing statement initially provided
11/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an eight week Bikram Yoga intervention on physiological attributes
Scientific title
Comparing the effect of an eight week Bikram Yoga intervention on physical, medical and psychological attributes of a group of healthy adults between 18-65, using a Pilates group and a sedentary group.
Secondary ID [1] 290223 0
Nil
Universal Trial Number (UTN)
U1111-1188-0510
Trial acronym
BYT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced mobility 300405 0
Poor balance 300406 0
Stress 300407 0
Elevated cholesterol 300408 0
Blood pressure 300409 0
Obesity 300410 0
Condition category
Condition code
Alternative and Complementary Medicine 300267 300267 0 0
Other alternative and complementary medicine
Musculoskeletal 300314 300314 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1
Participants will be of non-probability, convenience sampling based on eligibility on application. There will be eight weeks of thrice-weekly, group Bikram Yoga (90 minutes per session), carried out by a qualified Bikram Yoga teacher in a suitably designed hot Yoga studio, at 40 degrees C. (104 F). Classes involve standardised 26 sequential postures and 2 breathing exercises and will be taught by the same teacher. Attendance will be recorded in attendance register.

Intervention 2
Participants will be of non-probability, convenience sampling based on eligibility on application. There will be eight weeks of twice or thrice-weekly, group Pilates (90 minutes per session), carried out by a qualified Pilates teacher in a suitably designed Pilates studio. Normal room temperature will apply. Classes will insofar as possible include similar posture styles as in Bikram Yoga. Classes will be taught by the same teacher. Attendance will be recorded in attendance register.
Intervention code [1] 295996 0
Prevention
Intervention code [2] 295997 0
Rehabilitation
Intervention code [3] 295998 0
Lifestyle
Comparator / control treatment
A control group of sedentary, but otherwise healthy adults between 18-65 will be utilised. The control group will be offered participation in Bikram Yoga Classes, Hatha Yoga classes or fitness screening and exercise programs at an introductory rate similar to the other non-control participants.
Control group
Active

Outcomes
Primary outcome [1] 299744 0
Change in blood pressure as measured by sphygmomanometer.
Timepoint [1] 299744 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Primary outcome [2] 299745 0
Change in cholesterol level, measured using CardioChek blood test device.
Timepoint [2] 299745 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Primary outcome [3] 299748 0
Changes in stress level, measured by Perceived Stress Scale Test, PSS 10 Item.
Timepoint [3] 299748 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [1] 327988 0
Changes in quality of life, using Quality of life (short form) 36 Item Test.
Timepoint [1] 327988 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [2] 327989 0
Changes in mood, using Positive And Negative Affect Schedule (PANAS) Test.
Timepoint [2] 327989 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [3] 327990 0
Changes in body weight, using Seca scales.
Timepoint [3] 327990 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [4] 327991 0
Changes in static balance, using Stork Balance Test.
Timepoint [4] 327991 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [5] 327992 0
Changes in dynamic balance, using y-balance reach test.
Timepoint [5] 327992 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [6] 327993 0
Changes in body-fat, using Jackson/Pollock Four Point Body-fat Calculator.
Timepoint [6] 327993 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [7] 327994 0
Changes in spine flexibility, measured by goniometer- flexion, extension and lateroflexion.
Timepoint [7] 327994 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.
Secondary outcome [8] 327995 0
Changes in knee flexibility, using goniometer- knee- standing knee flexion.
Timepoint [8] 327995 0
Measured 7 days pre- or post- commencement of intervention and again, 7 days pre- or post- conclusion of intervention.

Eligibility
Key inclusion criteria
Healthy adult.
In the case of the sedentary group, participants are eligible if not involved in organised or regular fitness/physical activities aimed at maintaining/improving health and have not been engaging in more than 150 minutes of moderate exercise weekly in the previous six months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed medical conditions requiring current physical or drug therapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size justified using the G*Power software (Version 3), with a = 0.05, effect size f= 0.25, in 3 groups. with 3 repetitions.

The data will be presented in mean +/- SD, and statistical analyses will be processed in the SPSS (V20) and Microsoft Excel. Two-way repeated measures analysis of variance (ANOVA) will be applied to examine the possible interaction between groups. As for statistical significance, the post-hoc Bonferroni test (p < 0.05) will be conducted to determine pair wise differences

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/07/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
8/01/2018
Date of last data collection
Anticipated
7/04/2017
Actual
30/03/2018
Sample size
Target
42
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 8265 0
Ireland
State/province [1] 8265 0
Leinster

Funding & Sponsors
Funding source category [1] 294588 0
University
Name [1] 294588 0
Universiti Malaya
Country [1] 294588 0
Malaysia
Primary sponsor type
University
Name
Universiti Malaya
Address
Jalan Universiti
50603 Kuala Lumpur
Wilayah Perseketuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 293456 0
None
Name [1] 293456 0
Address [1] 293456 0
Country [1] 293456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296029 0
Universiti Malaya Research Ethics Committee (UMREC)
Ethics committee address [1] 296029 0
Ethics committee country [1] 296029 0
Malaysia
Date submitted for ethics approval [1] 296029 0
13/11/2014
Approval date [1] 296029 0
09/09/2015
Ethics approval number [1] 296029 0
UM. TNC 2/RC/H&E/UMREC

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

Contacts
Principal investigator
Name 69290 0
Mr Vinnie Mark Hall
Address 69290 0
Sports Centre Pusat Sukan Jalan Universiti 50603 Kuala Lumpur Wilayah Perseketuan Kuala Lumpur
Country 69290 0
Malaysia
Phone 69290 0
+60164360497
Fax 69290 0
Email 69290 0
[email protected]
Contact person for public queries
Name 69291 0
Vinnie Mark hall
Address 69291 0
Sports Centre Pusat Sukan Jalan Universiti 50603 Kuala Lumpur Wilayah Perseketuan Kuala Lumpur
Country 69291 0
Malaysia
Phone 69291 0
+60164360497
Fax 69291 0
Email 69291 0
[email protected]
Contact person for scientific queries
Name 69292 0
Vinnie Mark Hall
Address 69292 0
Sports Centre Pusat Sukan Jalan Universiti 50603 Kuala Lumpur Wilayah Perseketuan Kuala Lumpur
Country 69292 0
Malaysia
Phone 69292 0
+60164360497
Fax 69292 0
Email 69292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The decision on who it will be available to, will be made on a case by case basis.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Once data analysis has been completed, data that is relevant to the outcome will be shared.

What types of analyses could be done with individual participant data?
• This decision will be made on a cse by case basis.

When can requests for individual participant data be made (start and end dates)?
From:
Since the data analysis is ongoing, and other deadlines are critcal, these dates have not been finalised.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access will be subject to investigator's approval.

Are there extra considerations when requesting access to individual participant data?
No


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.