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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]

None

Universal Trial Number (UTN)

U1111-1210-4828

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Primary dysmenorrhea

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Prostaglandin metabolites including PGF2a, PGE2 in menstrual fluid from tampons

Timepoint [1]

Before (pre) and after (post) aerobic exercise intervention on first two days of the first and second menstrual periods

Secondary outcome [1]

11-point numeric rating scale for pain

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

Hung Hom, Kowloon

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Hong Kong Polytechnic Unviersity

Address [1]

Yuk Choi road
Hung Hom

Country [1]

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]

Individual

Name [1]

Cesar Wong

Address [1]

Y932
Health Technology and Informatics
The HK PolyU
Yuk Choi Road
Hung Hom

Country [1]

Hong Kong

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Human Subjects Ethics Committee, The HK PolyU

Ethics committee address [1]

The Hong Kong PolyU
Yuk Choi Road
Hung Hom

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

05/03/2018

Approval date [1]

Ethics approval number [1]

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

Dr Priya Kannan

Address

ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom

Country

Hong Kong

Phone

+852 3400 3277

Fax

[email protected]

Contact person for public queries

Name

Priya Kannan

Address

ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom

Country

Hong Kong

Phone

+852 3400 3277

Fax

[email protected]

Contact person for scientific queries

Name

Priya Kannan

Address

ST532, Rehabilitation Sciences
The HK Polytechnic University
Yuk Choi Road
Hung Hom

Country

Hong Kong

Phone

+852 3400 3277

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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