Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000450718
Ethics application status
Approved
Date submitted
22/02/2022
Date registered
23/03/2022
Date last updated
12/08/2024
Date data sharing statement initially provided
23/03/2022
Date results provided
27/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Yoga for BP2 (Blood Pressure Postpartum)
Scientific title
The acceptability and effect of a yoga-based mind body intervention in women with a history of hypertensive disorder in pregnancy: a feasibility study
Secondary ID [1] 306507 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High blood pressure 325372 0
Cardio vascular disease risk factors 325373 0
Poor quality of life 325375 0
Condition category
Condition code
Cardiovascular 322760 322760 0 0
Hypertension
Reproductive Health and Childbirth 322841 322841 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The yoga intervention is comprised of a multi-component pragmatic intervention informed by: evidence from prior research of yoga appropriate for postpartum women, studies of yoga for hypertension, yoga and risk factors for chronic disease, cross sectional yoga research and reviews together with yogic theory. The yoga-based mind body intervention has been designed specifically for this study.

The eight-week intervention will include a: 1) single two-hour yoga information session facilitated by the Yoga for BP2 Associate Investigator and Yoga Teacher via online video conference (i.e., Zoom); and 2) prescribed home practice adapted as required for individual needs. Content covered during the two-hour yoga information session will include a demonstration of the intervention, how to practice yoga at home (e.g., room spaces, yoga props). The mode of delivery will be online via video conference (i.e. Zoom) Presentations will utilise a PowerPoint deck and demonstration videos. Yoga information sessions will be held in small groups of no more than five participants to enable ample time for questions and interaction. To facilitate recruitment of 20 participants required for these information sessions will be repeated up to five times as new participants join the study.

Home yoga sessions will not be directly supervised. Women will be asked to practice yoga using written and video instructions at their own discretion. The Yoga Teacher will supervise the yoga intervention remotely via fortnightly phone calls to check-in on participants and enquire about adverse events, adverse reactions and yoga practice progression (duration estimated to be 15 minutes per call). Sessions will occur individually.
The level of expected intensity is light to moderate and will be assessed using the BORG Rating of Perceived Exertion Scale. During the eight-week intervention period, yoga practice frequency and duration will: 1) begin at 10 minutes per session (Weeks 1 - 4); and 2) subsequently increase by five minutes per session at Weeks 5 (to 15 minutes) and 7 (to 20 minutes). Participants will practice the yoga intervention as often as they wish, and at times during the day / evening most convenient for them. A minimum of three practice sessions per week will be encouraged, however daily yoga practice is highly desirable.
The yoga intervention is comprised of a multi-component pragmatic intervention informed by: evidence from prior research of yoga appropriate for postpartum women, studies of yoga for hypertension, yoga and risk factors for chronic disease, cross sectional yoga research and reviews together with yogic theory. The protocol itself consists of yoga tools and techniques that involve a range of: gentle breath centred yoga movements and postures (supine, kneeling and seated); short relaxation practices; and breathing techniques (e.g., Ujjayi and Bhramari / humming bee breath).
The intervention will be prescribed individualised yoga-based mind body intervention and can be tailored to suit participant needs. This will be achieved by: 1) completion of a researcher administered Yoga Questionnaire at intake that collects data: on prior yoga experience; health and fitness levels; injuries and underlying health conditions; and an observational assessment; and 2) fortnightly check-in phone calls that assess progress and any alterations which may needed to a woman’s yoga practice.
Adherence will be defined as the frequency (number and percentage) and duration (in minutes) of home yoga practice per session. Participants will have a maximum of 56 opportunities to do home yoga practice during the study (i.e., daily yoga practice during the eight-week intervention), where a minimum range of ten - 20 minutes of practice thrice weekly is encouraged over an eight-week period. Reasons for non-adherence will be analysed to determine barriers and challenges for home yoga practice.
For reporting purposes, participants will be designated into two groups depending on the number of weeks of yoga completed. Participants will be deemed: 1) ‘Completers’: if they complete greater than 4 weeks of yoga out of a total of 8 weeks; or 2) ‘Non-completers’: if they complete qual to 4 weeks of yoga out of a total of 8 weeks.
Intervention adherence will be monitored by fortnightly check-in phone calls made during Weeks two, four, six and eight where the Associate Investigator will record details of: adherence; the yoga practice given, and any further personalised adaptations needed for each individual. In addition, participants will also be asked to keep a: 1) diary record (i.e., Yoga Practice Diary) of each session of their home yoga practice, including details of: adherence , variations to the practice as given, reasons for non-adherence and any qualitative feedback; and 2) weekly log (i.e., Weekly Yoga Practice Log) that will track fidelity (in terms of the degree of perceived Meditative Connection and Breath Focus) using the Meditative Movement Inventory (MMI) and perceived level of activity intensity via the BORG Rating of Perceived Exertion Scale.



Intervention code [1] 322933 0
Lifestyle
Intervention code [2] 323097 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330556 0
Feasibility: Recruitment, withdrawal and follow up rates will be collected during the study and records will be audited at the end.
Timepoint [1] 330556 0
At the end of the intervention at 8 weeks post enrolment
Primary outcome [2] 330557 0
Adherence with the intervention assessed from participant log and diary.
Timepoint [2] 330557 0
End of the intervention at 8 weeks post enrolment.
Primary outcome [3] 330626 0
Adverse outcomes from the intervention. assessed from participant reporting. This could include slight muscle soreness.
Timepoint [3] 330626 0
Reported in yoga log and diary kept daily and assessed at the end of the intervention at 8 weeks post enrolment.
Secondary outcome [1] 406666 0
Change in systolic blood pressure assessed using a validated automated machine
Timepoint [1] 406666 0
Baseline at enrolment and the end of the intervention 8 weeks post enrolment
Secondary outcome [2] 406667 0
Change in quality of life assessed using the EQ-5D-5L Health Questionnaire
Timepoint [2] 406667 0
Baseline at enrolment and the end of the intervention 8 weeks post enrolment.
Secondary outcome [3] 406668 0
Changes in fasting triglycerides and cholesterol assessed from blood tests
Timepoint [3] 406668 0
Baseline at enrolment and the end of the intervention at 8 weeks post enrolment.
Secondary outcome [4] 406669 0
Changes in hsCRP assessed from blood tests
Timepoint [4] 406669 0
Baseline at enrolment and the end of the intervention 8 weeks post enrolment.
Secondary outcome [5] 406670 0
changes in HOMA (insulin resistance) score assessed from blood tests
Timepoint [5] 406670 0
Baseline at enrolment and of the intervention at 8 weeks post enrolment.
Secondary outcome [6] 406999 0
Participant satisfaction assessed by a non validated questionnaire designed for this study.
Timepoint [6] 406999 0
At the end of the intervention at 8 weeks post enrolment.
Secondary outcome [7] 407001 0
Questionnaire response rates, assessed from an audit of returned questionnaires in the study database.
Timepoint [7] 407001 0
End of the intervention 8 weeks post enrolment

Eligibility
Key inclusion criteria
• Able to understand and provide written informed consent.
• Able to read and speak English.
• The index pregnancy was complicated by a hypertensive disorder of pregnancy (HDP): preeclampsia (PE) (CH and SPE), gestational hypertension (GH), chronic hypertension ± superimposed PE classified as per the International Society for the Study of Hypertension in Pregnancy (ISSHP) Guidelines 2018..
• Have given birth in one of the recruitment hospitals in the last six months (range five to seven months postpartum).
• Have access to reliable Wi-Fi or internet connections at home.
• Not currently undertaking mindfulness or yoga practice in the previous six months.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Stillbirth or neonatal death from the index pregnancy
• Planning to move away from the study area preventing participation in the intervention of the study OR known unavailability to follow up during the study period.
• Concomitant conditions identified during screening or commencement of the yoga intervention that in the opinion of the Research Team may adversely affect the safety and efficacy of the yoga mind-body intervention, or severely limit the participant’s ability to complete the study. Examples include active severe mental health conditions or developmental disorder precluding informed consent

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to present and compare the women in both arms of the cohort. Continuous data will be compared utilising statistics appropriate for the attributes of the data distribution.

The primary analysis will describe baseline characteristics and examine within group differences of the yoga intervention using T tests.

Analysis of the secondary outcomes will be undertaken using descriptive statistics and conducted with tests for differences in the treatment groups to the control performed using Students t-test for continuous outcomes and chi-squared test for categorical outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2022
Actual
1/10/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
24/04/2023
Date of last data collection
Anticipated
30/06/2023
Actual
30/09/2023
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21801 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 21802 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 36859 0
2560 - Campbelltown
Recruitment postcode(s) [2] 36860 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 310850 0
Hospital
Name [1] 310850 0
WHITU (WOMENS HEALTH INITIATIVE TRANSLATIONAL UNIT)
Country [1] 310850 0
Australia
Primary sponsor type
Hospital
Name
Women's Health Initiative Translational Unit (WHITU)
Address
1 Campbell St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 312105 0
None
Name [1] 312105 0
Address [1] 312105 0
Country [1] 312105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310415 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310415 0
Ethics committee country [1] 310415 0
Australia
Date submitted for ethics approval [1] 310415 0
28/10/2021
Approval date [1] 310415 0
13/01/2022
Ethics approval number [1] 310415 0
2021/ETH11966

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

Contacts
Principal investigator
Name 117582 0
Prof Caroline Smith
Address 117582 0
THRI
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 117582 0
Australia
Phone 117582 0
+61419390755
Fax 117582 0
Email 117582 0
[email protected]
Contact person for public queries
Name 117583 0
Caroline Smith
Address 117583 0
THRI
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 117583 0
Australia
Phone 117583 0
+61419390755
Fax 117583 0
Email 117583 0
[email protected]
Contact person for scientific queries
Name 117584 0
Caroline Smith
Address 117584 0
THRI
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 117584 0
Australia
Phone 117584 0
+61419390755
Fax 117584 0
Email 117584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not obtained


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.