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Trial registered on ANZCTR


Registration number
ACTRN12618000784213
Ethics application status
Approved
Date submitted
3/05/2018
Date registered
9/05/2018
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a treadmill-based exercise intervention on biomarkers of pain in primary dysmenorrhea
Scientific title
Effects of a treadmill-based aerobic exercise intervention on pain biomarkers in blood plasma of women with primary dysmenorrhea
Secondary ID [1] 294784 0
None
Universal Trial Number (UTN)
U1111-1213-3434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhea 307707 0
Condition category
Condition code
Reproductive Health and Childbirth 306764 306764 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised treadmill-based aerobic exercise at a perceived exertion of 11.0 (Borg RPE) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of MHR (16-18.0 Borg scale) for 25 minutes. At the end of the exercise session, women will complete a 5-minute cooldown (11.0 Borg scale).
Exercise intervention will be done three times a week for up to 4 weeks.
The intervention will be supervised on a one-to-one basis by a physiotherapist with specialist experience in Women's health.Adherence to experimental intervention will be monitored by the study personnel. While participants are on the treadmill, the following data will be monitored every five minutes: (1) heart rate (HR) with a HR monitor (2) rate of perceived exertion using Borg’s 6-20 scale.
The intervention will be provided at the Department of Rehabilitation Sciences, the Hong Kong Polytechnic University.
Intervention code [1] 301095 0
Treatment: Other
Comparator / control treatment
No-exercise group: participants in the no-exercise group will not be provided study intervention.
Control group
Active

Outcomes
Primary outcome [1] 305793 0
Prostaglandin F2a levels in blood plasma
Timepoint [1] 305793 0
Pre-intervention assessment during the first menstrual period following entry into the study. Post-intervention assessment will be done during the second menstrual period i.e following fours weeks of aerobic exercise.
Primary outcome [2] 308082 0
PGE2 metabolite levels in blood plasma will be evaluated using ELISA.
Timepoint [2] 308082 0
Pre-intervention assessment during the first menstrual period following entry into the study. Post-intervention assessment will be done during the second menstrual period i.e following fours weeks of aerobic exercise.
Secondary outcome [1] 346376 0
Pain measured with 0-10 numerical rating scale
Timepoint [1] 346376 0
Pre-intervention assessment during the first menstrual period following entry into the study. Post-intervention assessment will be done during the second menstrual period i.e following fours weeks of aerobic exercise.
Secondary outcome [2] 353905 0
Progesterone levels in blood plasma
Timepoint [2] 353905 0
Pre-intervention assessment during the first menstrual period following entry into the study. Post-intervention assessment will be done during the second menstrual period i.e following fours weeks of aerobic exercise.
Secondary outcome [3] 353906 0
Pro-inflammatory cytokine, tumor necrosis factor -alpha levels in plasma
Timepoint [3] 353906 0
Pre-intervention assessment during the first menstrual period following entry into the study. Post-intervention assessment will be done during the second menstrual period i.e following fours weeks of aerobic exercise.

Eligibility
Key inclusion criteria
Non-pregnant women in the age group 18-29 years, with regular menstrual cycles, and menstrual pain equivalent to or greater than 4 on a 0-10 Visual Analogue Scale (VAS) will be considered eligible to participate in the study
Minimum age
18 Years
Maximum age
29 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, women having menstrual pain less than 4 out of 10 on visual analogue scale, women on formal exercise programme

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Only descriptive statistics and effect size (Cohen's d) will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10374 0
Hong Kong
State/province [1] 10374 0
Kowloon

Funding & Sponsors
Funding source category [1] 299391 0
University
Name [1] 299391 0
The Hong Kong Polytechnic University
Address [1] 299391 0
11 Yuk Choi Road, Hung Hom, Kowloon
Country [1] 299391 0
Hong Kong
Primary sponsor type
Individual
Name
Priya Kannan
Address
ST532, Rehabilitation Sciences,
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, Kowloon
Country
Hong Kong
Secondary sponsor category [1] 298670 0
Individual
Name [1] 298670 0
Stanley John Winser
Address [1] 298670 0
ST532, Rehabilitation Sciences,
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, Kowloon
Country [1] 298670 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300295 0
Human Subjects Ethics Sub-committee of the Hong Kong Polytechnic University
Ethics committee address [1] 300295 0
The Hong Kong Polytechnic University
11 Yuk Choi Road, Hung Hom
Kowloon
Ethics committee country [1] 300295 0
Hong Kong
Date submitted for ethics approval [1] 300295 0
27/04/2018
Approval date [1] 300295 0
15/05/2018
Ethics approval number [1] 300295 0
HSEARS20180426001

Summary
Brief summary
Objectives: (1) to identify the influence of aerobic exercise on prostaglandin (PGF2, PGE2, TXB2) levels in blood plasma of women with primary dysmenorrhea (2) to evaluate the effects of aerobic exercise on pain in women with primary dysmenorrhea.
Recruitment: Advertising will be done by posting study flyers around the University campus, waiting rooms of the PolyU University Health. The advertisement flyers will contain simple inclusion information as well as contact details of the principal investigator.
Exercise group: Women in the exercise group will perform supervised treadmill-based aerobic exercise at a perceived exertion of 11.0 (Borg RPE) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of MHR (16-18.0 Borg scale) for 25 minutes. At the end of the exercise session women will complete a 5-minute cool down (11.0 Borg scale).
No-exercise group: will not be provided study intervention. Participants will only be required to provide blood samples for estimation of prostaglandin levels and complete pain questionnaire.
Outcomes assessment time points: Collection of blood samples and measurement of pain intensity will be done on the first day of the first menstrual period following entry into study to establish baseline (pre-intervention; Month 0) plasma variables and pain intensity levels. Post-intervention assessment will during the second menstrual period. Study outcomes will be assessed on the day of maximum pain and bleeding which is usually the second day of menstrual period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83186 0
Dr Priya Kannan
Address 83186 0
ST532, Rehabilitation Sciences,
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, KowloonHung Hom
Country 83186 0
Hong Kong
Phone 83186 0
+852 3400 3277
Fax 83186 0
Email 83186 0
priya.kannan@polyu.edu.hk
Contact person for public queries
Name 83187 0
Dr Stanley Winser
Address 83187 0
ST532, Rehabilitation Sciences,
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, Kowloon
Country 83187 0
Hong Kong
Phone 83187 0
+852 3400 6746
Fax 83187 0
Email 83187 0
stanley.j.winser@polyu.edu.hk
Contact person for scientific queries
Name 83188 0
Dr Priya Kannan
Address 83188 0
ST532, Rehabilitation Sciences,
The Hong Kong Polytechnic University
11 Yuk Choi Road
Hung Hom, Kowloon
Country 83188 0
Hong Kong
Phone 83188 0
+852 3400 3277
Fax 83188 0
Email 83188 0
priya.kannan@polyu.edu.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
IPD will be provided if journal requests it.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary