High Intensity Aerobic Training on Primary Dysmenorrhea (HIAT)
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High Intensity Aerobic Training.
Low intensity Aerobic Training
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring pain, Dysmenorrhae symptoms, Menstrual Symptom Questionnaire
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.
Sites / Locations
- Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences).
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity Aerobic Training Group.
Control Group
Arm Description
The experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule.
The control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
SF-36 questionnaire
SF-36 questionnaire will be used for assessing the quality of life of all participants.
SF-36 questionnaire
SF-36 questionnaire will be used for assessing the quality of life of all participants.
Serum Progesteron level
Blood samples will be taken to measure Serum Progesteron level
Serum Progesteron level
Blood samples will be taken to measure Serum Progesteron level
Full Information
NCT ID
NCT04687722
First Posted
December 25, 2020
Last Updated
June 11, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04687722
Brief Title
High Intensity Aerobic Training on Primary Dysmenorrhea
Acronym
HIAT
Official Title
Effects of High Intensity Aerobic Training on Primary Dysmenorrhea Among Young Females.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
pain, Dysmenorrhae symptoms, Menstrual Symptom Questionnaire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated at the same time following their respective protocols.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Aerobic Training Group.
Arm Type
Experimental
Arm Description
The experimental group will receive High Intensity Aerobic Training at 80-90% of Heart Rate Maximum calculated using karvonen rule.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive routine low Intensity aerobic Training at 40-60% of Heart Rate Maximum calculated using karvonen rule.
Intervention Type
Other
Intervention Name(s)
High Intensity Aerobic Training.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low intensity Aerobic Training
Intervention Description
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 Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Post 8 weeks
Title
Menstrual Symptom Questionnaire
Description
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.
Time Frame
Baseline
Title
Menstrual Symptom Questionnaire
Description
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.
Time Frame
Post 8 weeks
Secondary Outcome Measure Information:
Title
SF-36 questionnaire
Description
SF-36 questionnaire will be used for assessing the quality of life of all participants.
Time Frame
Baseline
Title
SF-36 questionnaire
Description
SF-36 questionnaire will be used for assessing the quality of life of all participants.
Time Frame
Post 8 weeks
Title
Serum Progesteron level
Description
Blood samples will be taken to measure Serum Progesteron level
Time Frame
Baseline
Title
Serum Progesteron level
Description
Blood samples will be taken to measure Serum Progesteron level
Time Frame
Post 8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female participants will be recruited in the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences).
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25904964
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.
Results Reference
background
PubMed Identifier
26319652
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.
Results Reference
background
PubMed Identifier
16690671
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.
Results Reference
background
PubMed Identifier
25243766
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.
Results Reference
background
PubMed Identifier
29417063
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.
Results Reference
background
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High Intensity Aerobic Training on Primary Dysmenorrhea
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