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NCT Number: NCT04687722

High Intensity Aerobic Training on Primary Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences).

Islamabad, Fedral, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Aerobic Training.

Other

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.

Low intensity Aerobic Training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. SF-36 questionnaire

    Time frame: Baseline

    SF-36 questionnaire will be used for assessing the quality of life of all participants.

  2. SF-36 questionnaire

    Time frame: Post 8 weeks

    SF-36 questionnaire will be used for assessing the quality of life of all participants.

  3. Serum Progesteron level

    Time frame: Baseline

    Blood samples will be taken to measure Serum Progesteron level

  4. Serum Progesteron level

    Time frame: Post 8 weeks

    Blood samples will be taken to measure Serum Progesteron level

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Acronym: HIAT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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