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Clinical Trials/NCT04687722
NCT04687722CompletedNot Applicable

Effects of High Intensity Aerobic Training on Primary Dysmenorrhea Among Young Females.

Riphah International University1 site in 1 country40 target enrollmentStarted: February 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Numeric Pain Rating Scale (NPRS)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

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.

Arms & Interventions

High Intensity Aerobic Training Group.

Experimental

The experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule.

Intervention: High Intensity Aerobic Training. (Other)

Control Group

Active Comparator

The control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule.

Intervention: Low intensity Aerobic Training (Other)

Outcomes

Primary Outcomes

Numeric Pain Rating Scale (NPRS)

Time Frame: 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

Time Frame: 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.

Numeric Pain Rating Scale (NPRS)

Time Frame: Baseline

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

Time Frame: Baseline

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 Outcomes

  • SF-36 questionnaire(Post 8 weeks)
  • Serum Progesteron level(Post 8 weeks)
  • SF-36 questionnaire(Baseline)
  • Serum Progesteron level(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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