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CTRI Number  CTRI/2025/03/082698 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health education and exercise intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exercise and Education program to improve menopause specific quality of life in women 40-65 yrs in Chandigarh 
Scientific Title of Study   Effectiveness of a culturally appropriate integrated education and exercise intervention to improve quality of life among peri and postmenopausal women in Chandigarh: A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Negi 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room No-112 Department of Community Medicine and School of Public Health Postgraduate Institute of Medical Education and Research Chandigarh 160012, India

Chandigarh
CHANDIGARH
160012
India 
Phone  9646671933  
Fax    
Email  priyankapailoss@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhu Gupta 
Designation  Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Community Medicine and School of Public Health Postgraduate Institute of Medical Education and Research Chandigarh 160012, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7009769629  
Fax    
Email  madhugupta21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Negi 
Designation  Junior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Room No-112 Department of Community Medicine and School of Public Health Postgraduate Institute of Medical Education and Research Chandigarh 160012, India

Chandigarh
CHANDIGARH
160012
India 
Phone  9646671933  
Fax    
Email  priyankapailoss@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Priyanka Negi 
Address  Room No-112 Department of Community Medicine and School of Public Health Postgraduate Institute of Medical Education and Research Chandigarh 160012, India 
Type of Sponsor  Research institution and hospital 
 
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 Priyanka Negi  Postgraduate Institute of Medical Education & Research Sector-12, Chandigarh PIN- 160012, INDIA  Room No-112 Department of Community Medicine and School of Public Health
Chandigarh
CHANDIGARH 		 09646671933

priyankapailoss@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee(Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perimenopausal and Postmenopausal women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group-Health Education  Routine OPD services and health education based on there symptoms. The control group will be provided with the intervention package videos once the Study is completed. 
Intervention  Integrated Education and Exercise Package  Videos will be created containing exercise regimen and it will be delivered to the participants through online medium. In the module, online videos will be disseminated weekly for 12 weeks via WhatsApp. The videos will be developed in Hindi and the English language. There will be 1 introductory video and 11 small video sessions based upon week. Participants can go through the session in their own time as per their convenience.  Through the online medium the researcher and participant will be under continuous connection and if any doubt arises during any session, it can be asked at that point of time only. Exercises that will be included in the intervention- Aerobic exercises-Walking Isometric Exercises-Wall sits, straight leg raises, squats Strengthening Exercises- Kegel’s Exercise, Leg raise, pelvic tilt, Pelvic Bridging exercises The material for the Health Education will be based on educational content prepared from using valid and up-to-date scientific source (Guidelines from Indian Menopause Society,The International Menopause Society- Understanding menopause). 8 education videos will be prepared which will be disseminated weekly.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Peri and post-menopausal women of age group (40-65 years)
2. Resident of the study area in Chandigarh.
3. Participants who will give written informed consent.
4. Participants who have WhatsApp in there phone
 
 
ExclusionCriteria 
Details  1. Women who do not fall in the defined age group.

2. Women with a known history of chronic illness- Uncontrolled hypertension, uncontrolled diabetes mellitus, unstable cardiovascular disease, recent fracture or surgeries, severe osteoarthritis, neurological disorder affecting motor function and use of hormone replacement therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in Menopause specific quality of life total scores from baseline to post intervention in both intervention and control group.  Base line assessment(t0)
Immediate endline assessment postintervention(t1)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in proportion of women having Menopausal symptoms
2. Mean change in weight, waist circumference, waist hip ratio among the participants before and after the intervention.
3. Change in mean physical activity scores from baseline to post intervention in both intervention and control group.
4. Mean change in health, anxiety, well-being, resilience and coping scores from baseline to post intervention in both intervention and control group.
 		 Base line assessment(t0)
Immediate endline assessment postintervention(t1) 
 
Target Sample Size   Total Sample Size="266"
Sample Size from India="266" 
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)   29/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Recruitment of 266 eligible participants that is perimenopausal and postmenopausal women aged 40-65 years residing in the field practice area will be done by the principal investigator with the help of staff from Health and Wellness Centre, Sector -49. Informed consent and ethical considerations will be undertaken throughout the study.A computer-generated randomized sequence will be created using a randomization software. This sequence will be used to allocate them to either the intervention or control group. This sequence will be generated by an independent researcher not directly involved in the recruitment or implementation of intervention.The allocation sequence will be concealed until the participants are recruited and their baseline assessments are completed. Allocation concealment will be ensured to prevent selection bias.

 
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