High Intensity Aerobic Training on Primary Dysmenorrhea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Other: High Intensity Aerobic Training.
* Other: Low intensity Aerobic Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both experimental and control groups will be treated at the same time following their respective protocols.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Aerobic Training Group.<br>The experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule. | Other: High Intensity Aerobic Training.<br>* Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of high intensity aerobic training at 80-90% of heart rate maximum increased gradually on treadmill and elliptical trainer and then 2-5 minutes of low to moderate intensity cool down exercises.<br>|
| Active Comparator: Control Group<br>The control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule. | Other: Low intensity Aerobic Training<br>* Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of low intensity aerobic training at 40-60% of heart rate maximum increased gradually on elliptical trainer and jogging and then 2-5 minutes of low to moderate intensity cool down exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | 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. | Baseline | 
| Numeric Pain Rating Scale (NPRS) | 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. | Post 8 weeks | 
| Menstrual Symptom Questionnaire | 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. | Baseline | 
| Menstrual Symptom Questionnaire | 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. | Post 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 questionnaire | SF-36 questionnaire will be used for assessing the quality of life of all participants. | Baseline | 
| SF-36 questionnaire | SF-36 questionnaire will be used for assessing the quality of life of all participants. | Post 8 weeks | 
| Serum Progesteron level | Blood samples will be taken to measure Serum Progesteron level | Baseline | 
| Serum Progesteron level | Blood samples will be taken to measure Serum Progesteron level | Post 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Dysmenorrhae symptoms, Menstrual Symptom Questionnaire