Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000472279p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2018
Date registered
3/04/2018
Date last updated
3/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mechanism underlying the effectiveness of aerobic exercise on menstrual pain
Scientific title
Aerobic-exercise induced changes in prostaglandin levels in women with primary dysmenorrhea
Secondary ID [1] 294276 0
None
Universal Trial Number (UTN)
U1111-1210-4828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary dysmenorrhea 306963 0
Condition category
Condition code
Reproductive Health and Childbirth 306059 306059 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants: Thirty women (10 healthy women and 20 women with primary dysmenorrhea) will be placed in three groups: Group 1: healthy controls; Group 2: high-intensity aerobic exercise (HIE) and; Group 3: moderate-intensity aerobic (MIE) exercise.
Intervention: women in both HIE and MIE groups will complete supervised treadmill-based aerobic exercise for the first two days of menstruation for two menstrual cycles. Study intervention will be provided at the department of rehabilitation sciences, the Hong Kong Polytechnic University. Experimental intervention will be supervised by a physiotherapist on a one-on-one basis. 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.
Experimental intervention 1: acute bout of high-intensity aerobic exercise: women in the HIE group will perform supervised treadmill-based aerobic exercise at an intensity of up to 50% of their maximum heart rate (MHR) for the first five minutes (warm-up period), followed by 25 minutes of aerobic exercise at 70-85% of their MHR.
Experimental intervention 2: acute bout of moderate intensity aerobic exercise: women in the MIE group will perform 5-minute warm-up exercise similar to the HIE group followed by treadmill exercise for 25 minutes at 50-55% of their MHR.
Intervention code [1] 300565 0
Lifestyle
Comparator / control treatment
The study will have three groups:
Age-matched healthy women without primary dysmenorrhea will not receive the study intervention, they will only be monitored at the same time-points as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 305087 0
Prostaglandin metabolites including PGF2a, PGE2 in menstrual fluid from tampons
Timepoint [1] 305087 0
Before (pre) and after (post) aerobic exercise intervention on first two days of the first and second menstrual periods
Secondary outcome [1] 344120 0
11-point numeric rating scale for pain
Timepoint [1] 344120 0
Before (pre) and after (post) aerobic exercise intervention on first two days of the first and second menstrual periods

Eligibility
Key inclusion criteria
General inclusion criteria include non-pregnant women in the age group 18-29 years. Additional inclusion criteria for women with primary dysmenorrhea is having menstrual pain equivalent to or greater than 4 on a 0-10 Visual Analogue Scale (VAS).
Minimum age
18 Years
Maximum age
29 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) pregnant women (ii) women with irregular periods (iii) women using oral contraceptive pills, hormonal therapy, and intrauterine devices.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2018
Actual
Date of last participant enrolment
Anticipated
15/07/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 9662 0
Hong Kong
State/province [1] 9662 0
Hung Hom, Kowloon

Funding & Sponsors
Funding source category [1] 298912 0
University
Name [1] 298912 0
The Hong Kong Polytechnic Unviersity
Country [1] 298912 0
Hong Kong
Primary sponsor type
Individual
Name
Priya Kannan
Address
ST532
Rehabilitation Sciences
The HK PolyU
Yuk Choi Road
Hung Hom
Country
Hong Kong
Secondary sponsor category [1] 298126 0
Individual
Name [1] 298126 0
Cesar Wong
Address [1] 298126 0
Y932
Health Technology and Informatics
The HK PolyU
Yuk Choi Road
Hung Hom
Country [1] 298126 0
Hong Kong

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299854 0
Human Subjects Ethics Committee, The HK PolyU
Ethics committee address [1] 299854 0
The Hong Kong PolyU
Yuk Choi Road
Hung Hom
Ethics committee country [1] 299854 0
Hong Kong
Date submitted for ethics approval [1] 299854 0
05/03/2018
Approval date [1] 299854 0
Ethics approval number [1] 299854 0

Summary
Brief summary
Background: Painful menstruation associated with lower abdominal pain without any pelvic abnormality is primary dysmenorrhea. The pathophysiology of primary dysmenorrhea is primarily linked to elevated levels of prostaglandins (PGs) resulting in uterine contractions causing pain. Physiological mechanisms underlying the effectiveness of pharmacological and non-pharmacological interventions including analgesics, acupuncture, spinal manipulation, Chinese herbs, and ginger-partitioned moxibustion for primary dysmenorrhea is available in literature. However, the underlying mechanism of aerobic exercise-induced alleviation of pain associated with primary dysmenorrhea is not known. Similarly, the dose-response effect of aerobic exercise on primary dysmenorrhea-associated pain is also not known.
Objectives: (1) to identify the influence of aerobic exercise on prostaglandin (PGF2, PGE2, TXB2) levels in menstrual fluid of women with primary dysmenorrhea
(2) to investigate the dose-response effect of aerobic exercise on pain and prostaglandin levels in women with primary dysmenorrhea

Methods: 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.
Sampling method: Convenience sampling
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.

Participants: Thirty women (10 healthy women and 20 women with primary dysmenorrhea) will be placed in three groups: Group 1: healthy control group; Group 2: high-intensity aerobic exercise (HIE) group and; Group 3: moderate-intensity aerobic (MIE) exercise group.

Intervention: women in both exercise groups will complete supervised treadmill-based aerobic exercise for the first two days of menstruation for two menstrual cycles.

High-intensity aerobic exercise: women in the HIE group will perform supervised treadmill-based aerobic exercise at an intensity of up to 50% MHR for the first five minutes (warm-up period), followed by 25 minutes of aerobic exercise at 70-85% of their maximum heart rate (MHR).

Moderate-intensity aerobic exercise: women in the MIE group will perform 5-minute warm-up exercise similar to the HIE group followed by treadmill exercise for 25 minutes at 50-55% of their MHR.

Assessment time points: pre-and-post intervention pain assessment and tampons collection will be done prior to and 30 minutes after completion of treadmill exercise on first two days of menstruation. Participants will be followed up for two menstrual cycles.

Significance of the project: A better understanding of the mechanism underlying aerobic exercise-induced pain relief in primary dysmenorrhea would allow us to inform clinical practice and future research in the application of aerobic exercise. The proposed study will provide a scientific rationale for how aerobic exercise might alleviate the pain associated with primary dysmenorrhea. Pain is usually measured as a subjective phenomenon. This study is an initial effort to identify how biomarkers of pain in primary dysmenorrhea are influenced by aerobic exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81782 0
Dr Priya Kannan
Address 81782 0
ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom
Country 81782 0
Hong Kong
Phone 81782 0
+852 3400 3277
Fax 81782 0
Email 81782 0
priya.kannan@polyu.edu.hk
Contact person for public queries
Name 81783 0
Dr Priya Kannan
Address 81783 0
ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom
Country 81783 0
Hong Kong
Phone 81783 0
+852 3400 3277
Fax 81783 0
Email 81783 0
priya.kannan@polyu.edu.hk
Contact person for scientific queries
Name 81784 0
Dr Priya Kannan
Address 81784 0
ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom
Country 81784 0
Hong Kong
Phone 81784 0
+852 3400 3277
Fax 81784 0
Email 81784 0
priya.kannan@polyu.edu.hk

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