Clinical trial NCT04687722: High Intensity Aerobic Training on Primary Dysmenorrhea
Official title: Effects of High Intensity Aerobic Training on Primary Dysmenorrhea Among Young Females.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: pain
Dysmenorrhae symptoms
Menstrual Symptom Questionnaire
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both experimental and control groups will be treated at the same time following their respective protocols.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Post 8 weeks
measure: Menstrual Symptom Questionnaire
timeFrame: Baseline
measure: Menstrual Symptom Questionnaire
timeFrame: Post 8 weeks
Secondary outcomes:
measure: SF-36 questionnaire
timeFrame: Baseline
measure: SF-36 questionnaire
timeFrame: Post 8 weeks
measure: Serum Progesteron level
timeFrame: Baseline
measure: Serum Progesteron level
timeFrame: Post 8 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences).
state: Fedral
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaziri F, Hoseini A, Kamali F, Abdali K, Hadianfard M, Sayadi M. Comparing the effects of aerobic and stretching exercises on the intensity of primary dysmenorrhea in the students of universities of bushehr. J Family Reprod Health. 2015 Mar;9(1):23-8.
citation: Ortiz MI, Cortes-Marquez SK, Romero-Quezada LC, Murguia-Canovas G, Jaramillo-Diaz AP. Effect of a physiotherapy program in women with primary dysmenorrhea. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:24-9. doi: 10.1016/j.ejogrb.2015.08.008. Epub 2015 Aug 17.
citation: Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
citation: Kannan P, Claydon LS, Miller D, Chapple CM. Vigorous exercises in the management of primary dysmenorrhea: a feasibility study. Disabil Rehabil. 2015;37(15):1334-9. doi: 10.3109/09638288.2014.962108. Epub 2014 Sep 22.
citation: Dehnavi ZM, Jafarnejad F, Kamali Z. The Effect of aerobic exercise on primary dysmenorrhea: A clinical trial study. J Educ Health Promot. 2018 Jan 10;7:3. doi: 10.4103/jehp.jehp_79_17. eCollection 2018.