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CTRI Number  CTRI/2025/07/091931 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exercise for menstrual pain 
Scientific Title of Study   Effectiveness Of Aerobic Exercise Versus Isometric Exercise On Primary Dysmenorrhea 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamta Kumari Mandal 
Designation  Undergraduate Student 
Affiliation  Jashore University of Science and Technology 
Address  Room no:304 Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology



7408
Other 
Phone  8801740563634  
Fax    
Email  mamtamadhuri3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K M Amran Hossain  
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Room no: 404 Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  K M Amran Hossain  
Designation  Lecturer 
Affiliation  Jashore University of Science and Technology 
Address  Room no: 404 Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology



7408
Other 
Phone  8801735661492  
Fax    
Email  kma.hossain@just.edu.bd  
 
Source of Monetary or Material Support  
Room 306, Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore-7408, Bangladesh 
 
Primary Sponsor  
Name  Dr Ehsanur Rahman 
Address  Room no: 401 Department of Physiotherapy and Rehabilitation Jashore University of Science and Technology 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kabir Hossain  Musculoskeletal Lab   Room no: 301 Department of PTR JUST Bangladesh

 		 8801778315139

kabir2002pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Isometric Exercise  Isometric exercise group Static contraction exercise targeting abdominal & pelvic muscles such as bridging 3-4 session/week 20-30 minutes/session 8 weeks Each session includes warm up & cool down exercise 
Intervention  Aerobic Exercise   Aerobic exercise group Activities such as brisk walking jogging 3-4 session week 30-40 min/session 8 weeks moderate maintaining 60-70 % of maximum heart rate Cool Down and Warm Up 5 minutes 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Age 16-25 years Diagnosed with primary dysmenorrhea.
Regular menstruation cycle No pelvic pathology or secondary cause of dysmenorrhea.
 
 
ExclusionCriteria 
Details  History of Secondary Dysmenorrhea Irregular Menstrual Cycle Participants in Others Exercise Program During the Study Period Incomplete Questionnaire Having Pregnancy Chronic Disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Measure Pain Intensity by VAS Asses the Severity and Frequency of Menstrual Related Symptoms by MSQ   Week 0 Baseline Weeks 4 Midpoints Weeks 8 Post Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Assessed Menstrual Symptom Score by MSQ Scored on 0-3 Likert Scale To Assess the Change in Quality of Life by WHOQOL BREF  Baseline Week 0 Post Intervention Week 8 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kma.hossain@just.edu.bd].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This Randomized Clinical Trial Aims to Evaluate the Effectiveness of Aerobic Exercise versus Isometric Exercise on Primary Dysmenorrhea among Females Aged 16-25 Years of 8 Weeks. Eligible Participants Will be Randomly Assigned to Either the Aerobic Group Brisk Walking or Jogging 3-4 Sessions per Week 20-30 Minutes per Sessions or the Isometric Group Static Abdominal and Pelvic Exercises Like Bridging 3-4 Sessions per Week 30-40 Minutes per Sessions. Both Interventions will Continue for 8 Weeks with Warm Up and Cool Down Included. The Study Will Be Conducted at the Musculoskeletal Lab Department of Physiotherapy and Rehabilitation JUST Bangladesh. Outcome Measures Included VAS for Pain MSQ and QOL. 
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