Aerobic Exercise for Primary Dysmenorrhea
1 other identifier
interventional
130
0 countries
N/A
Brief Summary
Primary dysmenorrhea is common and can result in significant disability for many women, causing a high degree of discomfort and reduced quality of life (QoL). Our preliminary studies suggested that high-intensity aerobic training (HIAT) for 30 minutes, three times a week at 70%-85% of maximum heart rate was effective for decreasing pain and improving QoL in women suffering from primary dysmenorrhea. However, to date, no studies have evaluated the beneficial effects of HIAT on academic performance and absenteeism or the cost-effectiveness of HIAT for women with primary dysmenorrhea. Furthermore, the mechanisms underlying aerobic exercise-induced analgesia in primary dysmenorrhea remain unclear. Here, we propose a study to address this important knowledge gap by investigating the effects of HIAT on absenteeism and academic performance among university students with primary dysmenorrhea and examine the physiological mechanisms underlying aerobic exercise-induced analgesia by conducting a fully powered, randomised, controlled crossover trial. We also propose to conduct an economic evaluation to determine the cost-effectiveness of HIAT compared with a wait-listed control group receiving usual care, according to the societal and healthcare perspectives of Hong Kong. The results of this cutting-edge research will be important for clinicians, researchers, policymakers, and women with primary dysmenorrhea. The knowledge gained from the proposed study will be useful for researchers when designing future studies to identify the mediators of pain interventions for clinical improvements, which could themselves be the target of future interventions. The findings of the proposed study will inform decision-makers regarding the extent to which existing or standard and potential interventions can improve population health (effectiveness) and the resources required to implement these interventions (costs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 11, 2020
November 1, 2020
3 years
November 25, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Pre-intervention (baseline, 0 week)
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Post-intervention at 12 weeks
Pain intensity
Average pain intensity during the last 24 hours during menstruation will be assessed using the 0-10 Numeric Rating Scale, with 0 representing 'No pain' and 10 representing 'Worst imaginable pain'. Higher scores indicate greater pain severity
Post-intervention at 28 weeks
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Pre-intervention (baseline, 0 week)
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Post-intervention at 12 weeks
Absenteeism from university
A prospective electronic diary will be provided for each participant to record university absenteeism.
Post-intervention at 28 weeks
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Pre-intervention (baseline, 0 week)
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Post-intervention at 12 weeks
Academic performance
Academic performance will be measured using the self-reported 20-item academic performance questionnaire, which was developed to measure the impacts of menstrual symptoms on academic performance. Greater scores indicate greater severity of primary dysmenorrhea
Post-intervention at 28 weeks
Progesterone levels
Salivary levels of progesterone.
Pre-intervention (baseline, 0 week)
Progesterone levels
Salivary levels of progesterone.
Post-intervention at 12 weeks
Progesterone levels
Salivary levels of progesterone.
Post-intervention at 28 weeks
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Pre-intervention (baseline, 0 week)
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Post-intervention at 12 weeks
Prostaglandin F2-alpha levels
Salivary levels of prostaglandin F2-alpha
Post-intervention at 28 weeks
Secondary Outcomes (8)
Concentration
Pre-intervention (baseline, 0 week)
Concentration
Post-intervention at 12 weeks
Concentration
Post-intervention at 28 weeks
Dysmenorrhea daily diary
Pre-intervention (baseline, 0 week)
Dysmenorrhea daily diary
Post-intervention at 12 weeks
- +3 more secondary outcomes
Study Arms (2)
High-intensity aerobic training (HIAT)
EXPERIMENTALWomen will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE).
Wait-list control (WLC)
ACTIVE COMPARATORWomen in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics).
Interventions
Women will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE).
Women in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics).
Eligibility Criteria
You may qualify if:
- women in the age group of 18-24 years old;
- non-pregnant;
- having regular menstrual cycles with cycle lengths between 24 and 30 days;
- experiencing an average menstrual pain intensity equal to or greater than 5 on a 0-10 Numerical Rating Scale; and
- scoring low (\< 600 metabolic equivalent tasks \[MET\]/week) on the short-form of the International Physical Activity Questionnaire.
You may not qualify if:
- women using oral contraceptive pills, hormonal therapy, or intrauterine devices;
- women using over-the counter analgesics during menstruation to treat dysmenorrhea-associated pain and experience no pain relief with those analgesics; and
- women participating in any formal exercise programme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Priya Kannan, PhD
The Hong Kong Polytechnic Unviersity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 11, 2020
Study Start
September 1, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 11, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share