High Intensity Aerobic Training on Primary Dysmenorrhea

NCT04687722 | Completed

• 1 other identifier: Rec/00835 Iqra Imtiaz
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

pain; Dysmenorrhae symptoms; Menstrual Symptom Questionnaire

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• SF-36 questionnaire

  Baseline

• SF-36 questionnaire

  Post 8 weeks

• Serum Progesteron level

  Baseline

• Serum Progesteron level

  Post 8 weeks

Study Arms (2)

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.

Other: High Intensity Aerobic Training.

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.

Other: Low intensity Aerobic Training

Interventions

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.

High Intensity Aerobic Training Group.

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Only female participants will be recruited in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

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

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 25904964 BACKGROUND

• 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.

  PMID: 26319652 BACKGROUND

• 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.

  PMID: 16690671 BACKGROUND

• 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.

  PMID: 25243766 BACKGROUND

• 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.

  PMID: 29417063 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both experimental and control groups will be treated at the same time following their respective protocols.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 29, 2020
• Study Start: February 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)