Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001507370
Ethics application status
Approved
Date submitted
11/10/2017
Date registered
26/10/2017
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
15/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
#MindinBody: Impacts of two types of exercise (Bikram yoga versus Adrenaline HIT) on persistent pain in women with a history of trauma.
Scientific title
#MindinBody. An investigation into persistent pain from a psychobiological perspective: Impacts of two types of exercise (Bikram yoga versus Adrenaline HIT) on persistent pain in women with a history of trauma
Secondary ID [1] 290110 0
None
Universal Trial Number (UTN)
U1111-11887-3430
Trial acronym
#MindinBody
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pain 300207 0
Traumatic Stress Outcomes 300208 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300089 300089 0 0
Other physical medicine / rehabilitation
Mental Health 304448 304448 0 0
Other mental health disorders
Neurological 304449 304449 0 0
Other neurological disorders
Alternative and Complementary Medicine 304450 304450 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single blinded randomized control trial
#MindinBody. An investigation into persistent pain from a psychobiological perspective: A mixed-methods intervention study.
The exposure treatment is Bikram Yoga classes.
Participants' will be required to attend 3 group classes per week for a period of 8 weeks.
Exercise classes are being provided by various Bikram Yoga Studios sites throughout inner Melbourne.
Bikram yoga is a strictly standardized program across instructors and studio locations. Each Bikram yoga session is 90 minutes and consists of the same series of 26 postures with two breathing exercises and two resting postures and the room is held at a constant heat of 40 degrees and humidity of 40%.
Participants will be provided with a 24 class to the Bikram Yoga service provider of their choice (Prahran, Richmond, or Hawthorn).
Attendance will be monitored through the membership database of the Bikram yoga service provider as attendees are required to check in for each class and with fortnightly telephone contact check-ins by the researchers
Intervention code [1] 295862 0
Treatment: Other
Comparator / control treatment
The control treatment is Adrenaline HIT group fitness classes: 3 per week for 8 weeks (45 minute classes).
Adrenaline High Intensity Training (HIT) is an innovative functional fitness program designed to improve strength and conditioning in a focused, fun and social environment. Distinctly different from other types of group training, Adrenaline HIT™ focuses on functional movements in a small group setting. 10 to 15 participants work closely with a coach to perfect their form and technique, creating relevant real life results they can apply to everyday activities. Adrenaline HIT™ intensity is targeted towards approx. 70-80% HRmax but is ultimately defined by the individual and their ability to push themselves and has been developed to allow for an individual’s conditioning to be gradually built up, appropriately strengthening the joints to tolerate the stresses.
Adrenaline HIT consists of 4 workout formats:
-Time; completing a circuit training course as fast as possible
-Tabata: interval training utilising 8 functional exercises followed by a cardio or body-weight burst
-Reps: do a maximum reps or load in a set time
-Box: 12 mins to complete as many rounds of the 4 cross-training stations followed by a cardio burst
Adrenaline HITâ„¢ classes are being provided by various YMCA Vic. centres around Melbourne (Kew, Hawthorn, Northcote, and North Carlton) and classes are lead by specialist Adrenaline HITâ„¢ personal trainers from each site
The Adrenaline HIT classes have been chosen as the comparison group intervention because they provides an intense exercise program that is taken by an instructor and presented in a regimented format. Consequently it is anticipated to offer similar self-esteem and in group activity social situation gains to that of the Bikram yoga classes
Participants will be provided with a 24 class to the Adrenaline HITâ„¢ service provider of their choice.
Attendance will be monitored through the membership database at each of the YMCA Vic. sites as attendees are required to check in for each class and with fortnightly telephone contact check-ins by the researchers
Control group
Active

Outcomes
Primary outcome [1] 299566 0
Persistent Pain levels
Persistent Pain is being assessed using the Brief Pain Inventory (BPI).
The BPI provides an intensity/severity rating on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for current pain intensity, and pain in the last 24 hours at its worst, least and average.
As well as an interference scale across 7 domains of quality of life ratings, on a scale of 0 (does not interfere) to 10 (interferes completely). Both intensity and interference scales are scored as the means of the four and seven items respectively
Timepoint [1] 299566 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [1] 327534 0
Traumatic stress levels
Self-report Inventory for Disorders of Extreme Stress (SIDES-SR). The SIDES-SR is a self-report measure that assesses the six dimensions of impairment in Disorders of Extreme Stress. These are; affect regulation, amnesia and dissociation, somatization, disruptions in self-perception, disorders in relationships with others, and disrupted systems of meaning. For each item participants are required to indicate yes/no for lifetime presence, and also to rate the current symptom presence and severity during the past month from 0 to 3
Timepoint [1] 327534 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [2] 327535 0
Quality of Life
Medical Outcomes Study Short Form 36 Health Survey (SF-36). The SF-36 is a short form (36 questions) generic health survey providing 8 profile scores (physical functioning, role physical, general health, body pain, role emotional, social functioning, vitality and mental health) along with physical and mental health summary scores, all of which range from 0-100. Questions are asked around a participants’ present experience or during the last 4 weeks
Timepoint [2] 327535 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [3] 327536 0
Depression
DASS-21. The DASS scale provides a measure of general negative affective syndromes and consists of 21 negative emotional symptoms across depression, anxiety and stress (7 items each), where the experience of each symptom over the past week is rated on a 4-point severity/frequency scale. Scores are determined by summing the scores for the relevant 7 items
Timepoint [3] 327536 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [4] 339860 0
Coping self –efficacy.
The CSE scale provides a measure of a person’s perceived ability to cope effectively with life challenges, as well as a way to assess changes in CSE over time in intervention research. Items are rated on an 11-point scale the extent to which they believe they could perform behaviours important to adaptive coping and consists of 26 items where an overall score is created by summing the item ratings
Timepoint [4] 339860 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [5] 339861 0
History of trauamatic events
Life Stressor Checklist-Revised (LSC-R). LSC-R is a self-report measure that assesses traumatic and stressful experience across 30 life events, for example, death of a relative, natural disasters, and physical or sexual assault. If an event is endorsed then age when event began, age when event ended, belief that they were in harm (yes or no), and feelings of helplessness (yes or no). Participants’ are also required to report for each endorsed event; effect on life and how upsetting event was at the time on a five-point intensity scale (1 = not at all or never to 5 = extremely) and to identify the three events that currently have the greatest impact on them
Timepoint [5] 339861 0
Baseline before beginning the intervention (T0)
Secondary outcome [6] 339862 0
Mindfulness
Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item self-report assessing multiple facets of mindfulness. Participants’ are required to rate each item on a 5-point scale where 1= never or very rarely true, and 5= very often or always true. The five main facets representing mindfulness are; observing, describing, acting with awareness, non-judging of inner experience and non-reactivity to inner experience and combining the five factors provides a measure of multidimensional mindfulness as a whole
Timepoint [6] 339862 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [7] 339863 0
Weight measurement (kg)
Timepoint [7] 339863 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [8] 339864 0
Heart Rate (ECG output)
Timepoint [8] 339864 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [9] 339865 0
Blood Pressure (measured noninvasively using the auscultatory method)
Timepoint [9] 339865 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [10] 339866 0
Heart Rate Variability (ECG HRV analysis)
Timepoint [10] 339866 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [11] 339867 0
This is an exploratory outcome
Overnight fasting blood samples (10mls) collected through routine venepuncture: spun down to blood plasma for future analysis of stress hormones and inflammatory markers using the appropriate Enzyme Linked Immunosorbent Assay Kits.
Timepoint [11] 339867 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [12] 339868 0
Overnight fasting blood samples (10mls) collected through routine venepuncture: left as whole blood for analysis of DND methylation in relation to chronic stress; analysed with Methylation assays designed with Epidesigner software (www.epidesigner.com) covering key regions found to be deferentially methylated in previous studies investigating chronic stress outcomes)
Timepoint [12] 339868 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [13] 339869 0
This is an exploratory outcome
Overnight fasting blood samples (10mls) collected through routine venepuncture: 10mls spun down for glutathione (GHS) analysis using a Total Antioxidant Capacity Assay Kit
Timepoint [13] 339869 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [14] 340103 0
Anxiety
DASS-21. The DASS scale provides a measure of general negative affective syndromes and consists of 21 negative emotional symptoms across depression, anxiety and stress (7 items each), where the experience of each symptom over the past week is rated on a 4-point severity/frequency scale. Scores are determined by summing the scores for the relevant 7 items
Timepoint [14] 340103 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [15] 340104 0
Perceived Stress
DASS-21. The DASS scale provides a measure of general negative affective syndromes and consists of 21 negative emotional symptoms across depression, anxiety and stress (7 items each), where the experience of each symptom over the past week is rated on a 4-point severity/frequency scale. Scores are determined by summing the scores for the relevant 7 items
Timepoint [15] 340104 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [16] 340105 0
Waist measurements (cm)
Timepoint [16] 340105 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [17] 340106 0
Hip measurements (cm)
Timepoint [17] 340106 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)
Secondary outcome [18] 340107 0
Neck measurements (cm)
Timepoint [18] 340107 0
Baseline-before starting the intervention (T0) after completing the 8 week intervention (T1)

Eligibility
Key inclusion criteria
Female aged 20 to 50
Suffering non-malignant chronic pain, excluding headache for longer than 12 months
A self-reported history of traumatic life events
Able to provide a physician medical clearance to participate
Exercise less than 3 days per week for the past year
Minimum age
20 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Suffering pain that could potentially be attributable to specific underlying diseases or conditions; for example, metastatic cancer, spondylolisthesis, fractured bones, or dislocated joints
Having practiced in regular yoga, Pilates or group gym classes in the last year
BMI >40
A current diagnosis of diabetes, heart disease, hypertension, endocrine disorder, organic brain syndrome or other cognitive dysfunction
Peri or Post-Menopausal
Pregnant or breast feeding
At risk fdue to a 'moderate’ or ‘high’ for suicidality on MINI International Neuropsychiatric Interview
Insufficient understanding of English; for communication and reading and writing of text

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
The randomisation sequence was generated for 3 blocks of 20
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
Sample Size
The primary outcome measure is pain, which will be measured using the Brief Pain Inventory ‘severity’ component. Sample size was calculated to demonstrate a minimally clinical important difference in pain scores of 2.0, assuming a two-sided a=0.05, and using 2.35 as the standard deviation for the mean pain change scores between baseline and post-intervention (8 weeks), calculated from a range of previous pain studies utilising the Brief Pain Inventory measure in an allied intervention. A 26% dropout rate was also anticipated based on a previous Bikram yoga intervention study. Thus a total sample size of 60 participants randomized to either Bikram yoga or Adrenaline HIT interventions provides 80% power to demonstrate a minimally clinical important difference in pain scores of 2.0.

Intervention Analysis
Repeated measures ANOVA analysis; to assess the significance of the change in the outcome variables across time. This analysis will be conducted for each of the cohort members across two time points, immediately before intervention and immediately post intervention.
Repeated Measures ANCOVA analysis; to assess whether the post intervention means, adjusted for the pre-test scores, significantly differ between groups. This allows for a direct comparison in of treatment effectiveness between the two groups across outcome measures.

Baseline Analysis
Correlational analysis will be conducted to test for baseline associations between pain and traumatic stress outcomes

Subgroup analysis
Will be conducted to examine if there are any trends within the data when the participant data is split into trauma subgroups, physical injury, psychological injury, for example.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/10/2016
Date of last participant enrolment
Anticipated
Actual
21/08/2017
Date of last data collection
Anticipated
30/11/2017
Actual
15/08/2018
Sample size
Target
60
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294483 0
University
Name [1] 294483 0
Monash Univsersity
Country [1] 294483 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Location
Wellington Rd & Blackburn Rd, Clayton VIC 3800

Postal address
Monash University
Victoria 3800
Country
Australia
Secondary sponsor category [1] 293351 0
None
Name [1] 293351 0
NA
Address [1] 293351 0
NA
Country [1] 293351 0
Other collaborator category [1] 279209 0
Other
Name [1] 279209 0
Baker IDI Heart and Diabetes Institute
Address [1] 279209 0
Location
75 Commercial Road, Melbourne, Victoria 3004, Australia

Postal address
Baker IDI Heart and Diabetes Institute, PO Box 6492, Melbourne Victoria 3004, Australia

MELBOURNE, VICTORIA
Country [1] 279209 0
Australia
Other collaborator category [2] 279749 0
University
Name [2] 279749 0
Flinders University
Address [2] 279749 0
Sturt Road, Bedford Park
South Australia
5042 SA
GPO Box 2100
Adelaide SA 5001
Country [2] 279749 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295921 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 295921 0
First Floor, Room 111
Chancellery Building E
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 295921 0
Australia
Date submitted for ethics approval [1] 295921 0
22/06/2016
Approval date [1] 295921 0
06/09/2016
Ethics approval number [1] 295921 0
CF16/2156 - 2016001053

Summary
Brief summary
To investigate a psychobiological model of persistent pain in a mixed methods intervention study for women with persistent pain and a history of trauma, specifically:

To investigate the potential of Bikram yoga as a mind-body integrative persistent pain therapy. That is, to quantitatively assess the efficacy of an 8 week intervention (3 classes per week) of instructor lead Bikram yoga classes, as compared to coached Adrenaline HIT group gym class, on pain levels and the associated underlying psychobiological mechanisms (dysregulated stress response outcomes).
It is hypothesized that participants in the Bikram yoga group will show greater improvements in pain and stress dysregulation than the participants in the comparison Adrenaline HIT gym class group

To quantitatively assess a psychobiological model of persistent pain, that is, the relationship between trauma history, dysregulated stress response outcomes and persistent pain levels where it is hypothesized that greater stress dysregulation will be associated with increased levels of persistent pain
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1099 1099 0 0
/AnzctrAttachments/371458-#MindinBody Explanatory Statement.doc (Participant information/consent)
Attachments [2] 1100 1100 0 0
/AnzctrAttachments/371458-#MindinBody Consent Form.doc (Participant information/consent)
Attachments [3] 1101 1101 0 0
/AnzctrAttachments/371458-#MindinBody flyers with phone number.docx (Participant information/consent)
Attachments [4] 1102 1102 0 0
/AnzctrAttachments/371458-#MindinBody MUHREC 2016001053 Approval cert.pdf (Ethics approval)
Attachments [5] 1103 1103 0 0
/AnzctrAttachments/371458-Monash University Mail - MUHREC 2nd Amendment CF16_2156 - 2016001053 - #MindinBody.pdf (Ethics approval)
Attachments [6] 1104 1104 0 0
/AnzctrAttachments/371458-Monash University Mail - MUHREC 2nd Confirmation of Approval_ CF16_2156 - 2016001053 - #MindinBody.pdf (Ethics approval)
Attachments [7] 1105 1105 0 0
/AnzctrAttachments/371458-Monash University Mail - MUHREC Amendment CF16_2156 - 2016001053 - #MindinBody.pdf (Ethics approval)

Contacts
Principal investigator
Name 68890 0
Prof John Dixon
Address 68890 0
Baker Heart and Diabetes Institute
75 Commercial Rd, Melbourne VIC 3004
Country 68890 0
Australia
Phone 68890 0
+6138532 1111
Fax 68890 0
Email 68890 0
john.dixon@baker.edu.au
Contact person for public queries
Name 68891 0
Ms Alison Flehr
Address 68891 0
Department of General Practice
Monash University
270 Ferntree Gully Road
Notting Hill, Victoria 3168 AUSTRALIA
Country 68891 0
Australia
Phone 68891 0
+613 9902 4493
Fax 68891 0
+613 9902 4300
Email 68891 0
alison.flehr@monash.edu
Contact person for scientific queries
Name 68892 0
Ms Alison Flehr
Address 68892 0
Department of General Practice
Monash University
270 Ferntree Gully Road
Notting Hill, Victoria 3168 AUSTRALIA
Country 68892 0
Australia
Phone 68892 0
+613 9902 4493
Fax 68892 0
+613 9902 4300
Email 68892 0
alison.flehr@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The SPSS data set containing the de-identified participant information
When will data be available (start and end dates)?
August 2019 - ongoing
Available to whom?
Researchers
Available for what types of analyses?
Quantitative
How or where can data be obtained?
Contact either Alison Flehr or Prof John Dixon


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5152Study protocol  alison.flehr@monash.edu john.dixon@baker.edu.au



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Flehr, A., Barton, C., Coles, J., Gibson, S. J., L... [More Details] 371458-(Uploaded-30-09-2019-10-06-10)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Embase#MindinBody - Feasibility of vigorous exercise (Bikram yoga versus high intensity interval training) to improve persistent pain in women with a history of trauma: A pilot randomized control trial.2019https://dx.doi.org/10.1186/s12906-019-2642-1
N.B. These documents automatically identified may not have been verified by the study sponsor.