Aerobic Exercise for Primary Dysmenorrhea

NCT04665661 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-12-11

No results posted yet for this study

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).

Conditions

  • Primary Dysmenorrhea

Interventions

BEHAVIORAL

High-intensity aerobic training

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).

BEHAVIORAL

Wait-list control

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).

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Priya Kannan, PhD · The Hong Kong Polytechnic Unviersity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-08-31
Completion
2024-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665661 on ClinicalTrials.gov