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Primary DysmenorrheaHIATNCT04687722

High Intensity Aerobic Training on Primary Dysmenorrhea

A study testing High Intensity Aerobic Training. and Low intensity Aerobic Training in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primary Dysmenorrhea
What is being tested?
High Intensity Aerobic Training. and Low intensity Aerobic Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
1 Feb 2021to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

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

    Islamabad, Fedral, 44000

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
High Intensity Aerobic Training., Low intensity Aerobic Training
Keywords
pain, Dysmenorrhae symptoms, Menstrual Symptom Questionnaire
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 TrainingOther

    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.

Study groups in NCT04687722
Study groupRoleWhat they receive
High Intensity Aerobic Training Group.ExperimentalThe experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule.
Receives: Other: High Intensity Aerobic Training.
Control GroupActive comparatorThe control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule.
Receives: Other: Low intensity Aerobic Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Post 8 weeks

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Post 8 weeks

Secondary outcomes (4)

  1. SF-36 questionnaire

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

    Measured: Baseline

  2. SF-36 questionnaire

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

    Measured: Post 8 weeks

  3. Serum Progesteron level

    Blood samples will be taken to measure Serum Progesteron level

    Measured: Baseline

  4. Serum Progesteron level

    Blood samples will be taken to measure Serum Progesteron level

    Measured: Post 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start1 Feb 2021
  3. Primary completion30 Apr 2021
  4. Study completion30 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Both experimental and control groups will be treated at the same time following their respective protocols.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687722
Sponsor's protocol ID
Rec/00835 Iqra Imtiaz
Acronym
HIAT
Status last verified
Jun 2021
First submitted
25 Dec 2020
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25904964

  • 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.

    PubMed 26319652

  • 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.

    PubMed 16690671

  • 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.

    PubMed 25243766

  • 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.

    PubMed 29417063

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Aerobic Training. and Low intensity Aerobic Training in people with Primary Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04687722, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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