Effects of a treadmill-based exercise intervention on biomarkers of pain in primary dysmenorrhea

• Register: ANZCTR
• Last refreshed on: 19 November 2018
• Main ID: ACTRN12618000784213
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: Priya Kannan
• 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
• Date of first enrolment: 25/05/2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000784213.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;

Countries of recruitment

Hong Kong

Contacts

• Name: Dr Priya Kannan

• Name: Dr Stanley Winser

Key inclusion & exclusion criteria

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
Exclusion criteria: Pregnant women, women having menstrual pain less than 4 out of 10 on visual analogue scale, women on formal exercise programme

Age minimum: 18 Years
Age maximum: 29 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Menstruation and menopause

Primary dysmenorrhea;
Primary dysmenorrhea

Intervention(s)

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.

Primary Outcome(s)

PGE2 metabolite levels in blood plasma will be evaluated using ELISA.[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.]

Prostaglandin F2a levels in blood plasma [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(s)

Progesterone levels in blood plasma[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.]

Pain measured with 0-10 numerical rating scale[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.]

Pro-inflammatory cytokine, tumor necrosis factor -alpha levels in plasma[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 ID(s)

None

Source(s) of Monetary Support

The Hong Kong Polytechnic University

Secondary Sponsor(s)

Stanley John Winser

Ethics review

Status: Approved
Approval date:
Contact:

Human Subjects Ethics Sub-committee of the Hong Kong Polytechnic University

Results

• Results available: Yes
• Date Posted: 13/11/2018
• Date Completed: 11/11/2018