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CTRI Number  CTRI/2025/04/084121 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
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   How Exercises Can Help with Period Related Headache Symptoms 
Scientific Title of Study   Effectiveness of aerobic exercises in menstrual migraine 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Jahnavi  
Designation  Post graduation student  
Affiliation  Dayananda Sagar College of physiotherapy, Dayananda Sagar University.  
Address  HS312 Neuro Lab,3rd Floor, HS Building, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagara Kanakapura Road, Dt, Ramanagara

Bangalore Rural
KARNATAKA
562112
India 
Phone  8217591657  
Fax    
Email  jahnavimanjunathagowda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  M Jahnavi  
Designation  Post graduation student  
Affiliation  Dayananda Sagar College of physiotherapy, Dayananda Sagar University.  
Address  HS312 Neuro Lab,3rd Floor, HS Building, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagara


KARNATAKA
562112
India 
Phone  8217591657  
Fax    
Email  jahnavimanjunathagowda@gmail.com  
 
Details of Contact Person
Public Query  
Name  M Jahnavi  
Designation  Post graduation student  
Affiliation  Dayananda Sagar College of physiotherapy, Dayananda Sagar University.  
Address  HS312 Neuro Lab,3rd Floor, HS Building, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagara


KARNATAKA
562112
India 
Phone  8217591657  
Fax    
Email  jahnavimanjunathagowda@gmail.com  
 
Source of Monetary or Material Support  
Dayananda Sagar college of physiotherapy, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagara, Karnataka, India 562112 
 
Primary Sponsor  
Name  M Jahnavi 
Address  HS312 Neuro Lab,3rd Floor, HS Building, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srihari K N Sharma  Dayananda Sagar University   HS312 Neuro Lab,3rd Floor, HS Building, School of Health Sciences Dayananda Sagar College of physiotherapy, Dayananda Sagar University Devarakaggalahalli, Harohalli, Ramanagara 562112
Bangalore Rural
KARNATAKA 		 9886040520

srihari-physio@dsu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dayananda Sagar University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G438||Other migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic exercise   Subjects will be given warm up exercises for 5 mins followed by 30 mins Aerobic exercise with FITTs of : F: 3 days a week I: 60% HRmax T: Aerobic exercise T: 30 mins At the end 30 mins 5 mins cool down exercises will be given to the subjects. This procedure will be repeated for 3 session every week for 8 weeks. Warm ups: 5 mins ( increase heart rate b/w 10-20 beats) Arm circles 15 reps Front and back leg swings 15 reps Lateral leg swings 15reps Trunk rotations 15 reps Jogging in same place 45 secs Hopping in same place 45 secs Aerobic exercise : 30 mins Thread-mill walking 15mins ( 4 kms/hr) Torso twists 10 reps* 3 sets Air jump ropes 20 reps * 3 sets. Cool down: 5 mins Overhead stretch 10reps 5secs hold Shoulder stretch 10reps 5secs hold Quads and hams stretch 10 reps 5secs hold Forward bending 10reps 5secs hold Child pose 10reps 5secs hold Cobra stretch 10reps 5secs hold.  
Comparator Agent  Lifestyle Modification Advise  Subjects were advised Maintain a Healthy Diet Eat Regularly: Skipping meals can trigger migraines. Have balanced meals at regular intervals. Hydration: Drink at least 2-3 litres of water daily to prevent dehydration. Limit Triggers: Avoid processed foods, caffeine, alcohol, and artificial sweeteners, as these can trigger dehydration and migraines. Magnesium-Rich Foods: Include nuts, seeds, leafy greens, and whole grains to support neurological function. Manage Stress Practice deep breathing, meditation, or progressive muscle retaxation techniques! Engage in hobbies or leisure activities that promote relaxation. Maintain a consistent steep schedule to regulate hormonal balance. Improve Sleep Quality Sleep for 7-9 hours per night in a dark, quiet room. Avoid screens and blue light at least 1 hour before bed. Stick to a fixed sleep-wake cycle, even on weekends. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Headache during mensuration
score above menstrual migraine scale
females willing to participate in the study and sign informed consent form 
 
ExclusionCriteria 
Details  Diagnosed with other type of Migraine
Pregnant or Lactating women
Any preexisting medical conditions  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Menstrual migraine scale
Numeric Pain Rating Scale (NPRS)
 		 week 1, week 8 and week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Headache Disability Index  week 1 week 8 & week 12 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/04/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/06/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Summery:
This study is a randomized, experimental, parallel-group, single-center trial assessing the effectiveness of aerobic exercises in menstrual migraine. Additionally, it compares the effectiveness of aerobic exercises and lifestyle modification in managing menstrual migraine. The trial will be conducted at Dayananda Sagar University, Harohalli, over six months, involving adult participants aged 19–40 years diagnosed with menstrual migraine.
Participants (n=36) will be randomly assigned to either the aerobic exercise group (n= 18) or the lifestyle modification group(n=18) for 8 weeks. The primary outcome measures will be the Numeric Pain Rating Scale (NPRS) and the Menstrual Migraine Scale at the beginning and end of the study. Secondary outcomes will include the Headache Disability Index before and after intervention .
The inclusion criteria include adults (19–40 years) experiencing menstrual migraine with a Menstrual Migraine Scale score above 20 and willingness to provide informed consent. Exclusion criteria include pre-diagnosed migraines of other types, pregnancy, lactation, and any pre-existing conditions. The sample size is yet to be determined.
 
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