Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001273178
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
16/09/2019
Date last updated
8/03/2023
Date data sharing statement initially provided
16/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can high intensity exercise reduce period pain? A pilot feasibility study.
Scientific title
Can high intensity exercise reduce period pain? A pilot feasibility study.
Secondary ID [1] 298975 0
None
Universal Trial Number (UTN)
U1111-1238-3473
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhoea 313962 0
Condition category
Condition code
Reproductive Health and Childbirth 312364 312364 0 0
Menstruation and menopause
Renal and Urogenital 312521 312521 0 0
Normal development and function of male and female renal and urogenital system
Physical Medicine / Rehabilitation 312522 312522 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: High intensity exercise - "F45"

PROCEDURE: Participants will be asked to attend four F45 classes per week based on their own personal schedule. These classes will be provided free of charge as part of this study. Two of the four classes attended will have a cardiovascular focus and the other two a strength training focus. All classes will be the standard 45 minutes (as per F45 structured training protocols).

For the purpose of this study, 'high intensity' has been defined according to the guide provided by F45, which is 75% of heart rate maximum (calculated by 206.3-[0.711 x age]). This is constantly measured by a heart rate monitor that is worn throughout the 45 minute class.

Participants will attend general F45 classes that will also be attended by members of the public. These classes are not designed specifically for this trial, but instead for a general F45 population. Class sizes differ based on the number and difficulty of exercises, as well as the equipment required. Class sizes range from a maximum of 27-36 per class; however, class sizes may be smaller depending on attendance numbers.

The exercises in each class vary, but the classes use a format of approximate 30-40 seconds of work and 10-20 seconds of rest for all exercises. Examples of exercises in the 'cardiovascular' classes include: burpees, skipping, and stationary cycling. Examples of exercises in the 'strength' classes include: dead lifts, dumb bell bench press, and pull ups.

The classes are structured sessions which are designed by exercise scientists. The exercises in each class are projected onto television screens throughout the gym. Certified fitness instructors supervise participants to ensure fidelity to the set exercises.

Adherence to the exercise program will be done in two ways: first, an attendance checklist will be taken by F45 and provided to the research team; and second, participants will be phoned weekly and asked to provide their attendance rate.

Participants in the exercise group will perform the exercise intervention for 45 sessions over 12 weeks in total. A ‘ramp up’ process will be used, where women are asked to do two sessions for the first week, then three for the second week before moving to the 4/week for the remainder of the 10 weeks (total 45 sessions).
Intervention code [1] 315239 0
Behaviour
Intervention code [2] 315240 0
Lifestyle
Intervention code [3] 315367 0
Treatment: Other
Comparator / control treatment
The comparator will be a wait-list control. Participants in this group will be instructed to continue their daily routines as normal for a 12-week period. Once the 12-week wait-list period is complete, women will begin the same exercise intervention as the F45 group.
Control group
Active

Outcomes
Primary outcome [1] 321088 0
Recruitment feasibility data:
- Online screening - as a proportion of the final number included in trial versus the number of women screened online (screening through Qualtrics in a trial-specific questionnaire related to inclusion/exclusion criteria)
- Telephone screening - as a proportion of the final number included in trial versus the number of women screened via telephone (screening done using trial-specific questions related to inclusion/exclusion criteria)
Timepoint [1] 321088 0
At the completion of recruitment of participants
Primary outcome [2] 321089 0
Retention rate as determined by proportion of participants who drop-out of trial.
Reasons for drop-out will also be considered as determined by the qualitative responses on the trial exit questionnaire (questionnaire designed specifically for this trial).
Timepoint [2] 321089 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Primary outcome [3] 321090 0
Attendance - as a proportion of the actual attended sessions (measured by attendance check list data) versus required sessions
Timepoint [3] 321090 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group)
Secondary outcome [1] 373954 0
Change in menstrual pain as determined by Menstrual Pain Diary reports
Timepoint [1] 373954 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [2] 373955 0
Change in menstrual pain causing medication use as determined by self-reported analgesic use during menstruation (collected as part of Menstrual Pain Diary)
Timepoint [2] 373955 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [3] 373956 0
Change in menstrual pain impact as determined by the Pelvic Pain Impact Questionnaire reports
Timepoint [3] 373956 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [4] 374130 0
PRIMARY OUTCOME: Recruitment success - as percentage of where all screened and included participants were recruited from (e.g. social media, word of mouth, referral from health/medical practitioner - this data will be collected in the trial-specific questionnaire used to screen participants online)
Timepoint [4] 374130 0
At the completion of recruitment of participants
Secondary outcome [5] 374131 0
PRIMARY OUTCOME: Compliance to intervention - as a proportion of the actual session types attended (measured by attendance check list data) versus the required sessions attended
Timepoint [5] 374131 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group)
Secondary outcome [6] 374132 0
PRIMARY OUTCOME: Adverse events during intervention - as the number of adverse events reported during the exercise sessions (measured by self report in the trial-specific monthly questionnaire run online, as well as weekly telephone call to participants where they are asked about adverse events).
Possible adverse events include: physical harm during the exercise sessions
due to the use of equipment and exercise machines and discomfort following intervention (delayed onset muscle soreness). The risk of these occurring is small.
Timepoint [6] 374132 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group)
Secondary outcome [7] 374133 0
PRIMARY OUTCOME: Compliance to outcome measures - as a proportion of the actual completed outcome measures (number of combined monthly MPD and PPIQ completion) versus the required outcome measures to be completed
Timepoint [7] 374133 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [8] 374134 0
PRIMARY OUTCOME: Adverse events during outcome measurement sessions - as the number of adverse events reported during outcome measurement (measured by self report).
Possible adverse events include: physical harm during the outcome measurement sessions due to the use of equipment undertaking exercise. The risk of this occurring is small.
Timepoint [8] 374134 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [9] 374638 0
PRIMARY OUTCOME: Adverse events during intervention - as the severity of adverse events reported during the exercise sessions (measured by self report in the trial-specific monthly questionnaire run online, as well as weekly telephone call to participants where they are asked about adverse events; severity determined by NHMRC document 'Safety monitoring and reporting in clinical trials').
Possible adverse events include: physical harm during the exercise sessions
due to the use of equipment and exercise machines and discomfort following intervention (delayed onset muscle soreness). The risk of these occurring is small.
Timepoint [9] 374638 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group)
Secondary outcome [10] 374639 0
PRIMARY OUTCOME: Adverse events during outcome measurement sessions - as the severity of adverse events reported during outcome measurement (measured by self report; severity determined by NHMRC document 'Safety monitoring and reporting in clinical trials').
Possible adverse events include: physical harm during the outcome measurement sessions due to the use of equipment undertaking exercise. The risk of this occurring is small.
Timepoint [10] 374639 0
At the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group) and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [11] 374643 0
Change in fitness using the multi-stage fitness test (beep test) score
Timepoint [11] 374643 0
At baseline, the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group), and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [12] 374644 0
Change in body composition using BMI (body weight in kilograms recorded via scales, heigh in metres recorded using stadiometer, BMI calculated using formula: weight (kg) / [height (m)]2).
Timepoint [12] 374644 0
At baseline, the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group), and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [13] 374645 0
Change in body composition using bioelectrical impedance analysis data (body fat percent)
Timepoint [13] 374645 0
At baseline, the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group), and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [14] 374646 0
Change in body composition using hip/waist ratio (in centimetres, recorded using measuring tape)
Timepoint [14] 374646 0
At baseline, the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group), and at follow up (3 months for F45 group, 6 months for wait-list control group).
Secondary outcome [15] 374647 0
Change in internal health locus of control (recorded as a whole number on the Internal Locus of Control Scale form A, outlined by Wallston, Wallston, & DeVellis 1978)
Timepoint [15] 374647 0
At baseline, the completion of the intervention (12-weeks for F45 group, 24-weeks for wait-list control group), and at follow up (3 months for F45 group, 6 months for wait-list control group).

Eligibility
Key inclusion criteria
• Women aged 18-30
• Regular menstrual pain (greater than or equal to 4/10 severity on numerical rating scale) on at least two days during the last two of three menstrual cycles
• Regular menstrual cycle (24-34 days)
• No physical limitations that would prevent undertaking a vigorous exercise program
• Able to attend four F45 classes per week for 3 months
• Not currently doing more than 120 minutes of structured, moderate or greater intensity exercise per week (e.g. gym, running, cycling)
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of secondary dysmenorrhoea (including endometriosis, PCOS, and other pathologies capable of causing menstrual pain)
• Changes in hormonal contraceptive use (start, stop, or changing dose) within the past 6 months
• Other chronic pain disorder (pain on most days lasting longer than 3 months)
• BMI >40
• Pregnant women or women planning on become pregnant during the study period

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)
Castor EDC provides built in allocation concealment. PI Chalmers and PI Armour will have the secure login details for Castor EDC. Once a participant is eligible and has provided consent, either PI Chalmers or PI Armour will login to Castor and randomise the participant. An email will be sent to both PI Armour and PI Chalmers with the group allocation and Study ID. The research assistant/clinical trial co-ordinator will not have access to the randomisation function and will be unable to determine which group participants are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using the online randomisation service provided by Castor EDC.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Wait-list control
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline measurements will be compared via t-test or Fisher’s exact test to explore differences between groups at baseline. As participants will be randomly allocated to a group, we anticipate that groups will be similar at baseline.

Due to the feasibility nature of the study, inferential statistics of outcome measures is not appropriate. Outcomes will be presented as mean (SD) and 95% confidence intervals for the following, by group:
- Pre-intervention/post-intervention/follow-up:
• BMI
• Body composition (bioelectrical impedance analysis)
• Hip/waist ratio
• Multi-stage fitness test
• Menstrual Pain Diary
• Pelvic Pain Impact Questionnaire
• Analgesic use

- During intervention:
• Menstrual Pain Diary
• Pelvic Pain Impact Questionnaire
• Analgesic use
• Exercise compliance

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial impacted by COVID 19 lockdowns and unable to be completed.
Date of first participant enrolment
Anticipated
20/09/2019
Actual
20/09/2019
Date of last participant enrolment
Anticipated
1/01/2020
Actual
1/01/2020
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
30
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303512 0
University
Name [1] 303512 0
Western Sydney University - DAP/ACA Researcher Development Grant
Country [1] 303512 0
Australia
Funding source category [2] 303639 0
Other Collaborative groups
Name [2] 303639 0
F45 Bulli and F45 Corrimal
Country [2] 303639 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 303655 0
None
Name [1] 303655 0
Address [1] 303655 0
Country [1] 303655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304037 0
Western Sydney University Human Ethics Committee
Ethics committee address [1] 304037 0
Ethics committee country [1] 304037 0
Australia
Date submitted for ethics approval [1] 304037 0
31/01/2019
Approval date [1] 304037 0
01/04/2019
Ethics approval number [1] 304037 0
H13115

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

Contacts
Principal investigator
Name 95622 0
Dr K Jane Chalmers
Address 95622 0
Western Sydney University
School of Science and Health
Campbelltown Campus 24.2.115
Locked Bag 1797
Penrith NSW 2751
Country 95622 0
Australia
Phone 95622 0
+61 246203851
Fax 95622 0
Email 95622 0
[email protected]
Contact person for public queries
Name 95623 0
K Jane Chalmers
Address 95623 0
Western Sydney University
School of Science and Health
Campbelltown Campus 24.2.115
Locked Bag 1797
Penrith NSW 2751
Country 95623 0
Australia
Phone 95623 0
+61 246203851
Fax 95623 0
Email 95623 0
[email protected]
Contact person for scientific queries
Name 95624 0
K Jane Chalmers
Address 95624 0
Western Sydney University
School of Science and Health
Campbelltown Campus 24.2.115
Locked Bag 1797
Penrith NSW 2751
Country 95624 0
Australia
Phone 95624 0
+61 246203851
Fax 95624 0
Email 95624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4098Ethical approval    378141-(Uploaded-16-08-2019-11-00-28)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.