High Intensity Aerobic Training on Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Other: High Intensity Aerobic Training.; Other: Low intensity Aerobic Training

• Registration Number: NCT04687722
• Lead Sponsor: Riphah International University

Brief Summary

Now a days Aerobic Exercise programs has been widely used as non-pharmacological means of treating pain disorders. This study intends to determine the effects of high intensity aerobic training on pain intensity, dysmenorrhea symptoms and quality of life of young girls having primary dysmenorrhea.

Detailed Description

This study is a Randomized Control Trial, which will be conducted in Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences). the calculated Sample size is 24 individuals using Epitool with 95% Confidence Interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 12 in High Intensity Aerobic training group and 12 in Low Intensity Aerobic Training group by sealed envelope method. High Intensity Aerobic Training will be use in experimental group. Low Intensity Aerobic Training will be used in Control group. Assessment will be done on baseline day 1 prior to the intervention and after 8 weeks of training.

Study Timeline

• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-29
• Study Start: 2021-02-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Unmarried female students.
• Moderate to severe dysmenorrhea during the last three periods according to the Numeric Pain Rating Scale.

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Exclusion Criteria

• Presence of known chronic disease (heart disease, kidney, respiratory, asthma, diabetes, nervous disorders, blood pressure), limitation on sports/physical activities due to special medical problems.
• Presence of any disease of reproductive system.
• Irregular monthly cycle.
• Use of any particular medications affecting dysmenorrhea before or during the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Aerobic Training Group.	High Intensity Aerobic Training.	The experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule.
Control Group	Low intensity Aerobic Training	The control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	Post 8 weeks	Numeric Pain Rating Scale (NPRS) will be used for measuring pain intensity of all participants by single examiner. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Menstrual Symptom Questionnaire	Post 8 weeks	Menstrual Symptom Questionnaire will be used for measuring the severity of dysmenorrhea symptoms. It consisted of 25 items questions, participants are asked to indicate degree of their symptoms experience.

Secondary Outcome Measures

Name	Time	Method
SF-36 questionnaire	Post 8 weeks	SF-36 questionnaire will be used for assessing the quality of life of all participants.
Serum Progesteron level	Post 8 weeks	Blood samples will be taken to measure Serum Progesteron level

Trial Locations

Locations (1)

Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences).; 🇵🇰 Islamabad, Fedral, Pakistan