| CTRI Number |
CTRI/2025/07/090463 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of exercise on mood and quality of life in endometriosis |
|
Scientific Title of Study
|
Effect of Structured Exercise program versus Home based aerobic exercise on Quality of life, depression, anxiety, stress in women with Diagnosed Endometriosis- A open label single blinded 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 |
Bhavana Mohota |
| Designation |
Post graduate student |
| Affiliation |
KJ Somaiya College of Physiotherapy Mumbai |
| Address |
KJ Somaiya college of Physiotherapy Ayurvihar complex Eastern Express Highway Sion East Mumbai, Maharashtra pin code- 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9370566130 |
| Fax |
|
| Email |
bhavanamohota1802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavana Mohota |
| Designation |
Post graduate student |
| Affiliation |
KJ Somaiya College of Physiotherapy Mumbai |
| Address |
KJ Somaiya college of Physiotherapy Ayurvihar complex Eastern Express Highway Department of community physiotherapy Women health OPD no 25 Sion East Mumbai, Maharashtra pin code- 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9370566130 |
| Fax |
|
| Email |
bhavanamohota1802@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pothiraj Pitchai |
| Designation |
Guide and Professor |
| Affiliation |
KJ Somaiya college of Physiotherapy Mumbai |
| Address |
KJ Somaiya college of Physiotherapy Ayurvihar complex Eastern Express Highway Department of community physiotherapy women health OPD no 25 Sion East Mumbai Maharashtra pin code- 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8779362373 |
| Fax |
|
| Email |
pothirajpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy Ayurvihar Complex, Eastern express highway , Sion east Mumbai Maharashtra pin code - 400022 |
|
|
Primary Sponsor
|
| Name |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of physiotherapy Ayurvihar Complex Eastern Express Highway Sion East Mumbai, Maharashtra pin code- 400022 |
| Type of Sponsor |
Other [KJ Somaiya College of Physiotherapy] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavana Mohota PT |
KJ Somaiya college of physiotherapy |
KJ Somaiya college of Physiotherapy Ayurvihar Complex Department of community physiotherapy women health OPD no 25 eastern express highway Sion East Mumbai, Maharashtra pin code- 400022
Mumbai
MAHARASHTRA |
9370566130
bhavanamohota1802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee KJ Somaiya college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N738||Other specified female pelvic inflammatory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home based aerobic exercise |
home based aerobic exercise will be for 45 mins . these will include warm up along with brisk walking followed by cool down involving streach and along with this lifestyle modification will be given regarding diet, sleep and hydration. This will be for a period of 6 weeks. |
| Intervention |
structured exercise program |
This structured exercise program will be for 45 mins. these session will include breathing exercise, stretching, core stabilization exercises, pelvic floor exercises. this exercises will be given for a period of 6 weeks. Thrice every week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women in reproductive age group of 18 to 45 years who are diagnosed with endometriosis and are fulfilling mild to moderate scoring criteria of either one component included in depression, anxiety and stress scale and those who are willing to participate |
|
| ExclusionCriteria |
| Details |
pregnant women, women with severe depression 14 and above, anxiety score 10 and above and stress score 17 and above on DASS-21 scale, women on antidepressants, underwent major surgical procedure to remove uterus, ovaries and fallopian tube, exercising regularly, women with recent lower limb trauma,any recent surgery in past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)endometriosis health profile-30 (EHP-30)
2) Depression, Anxiety and stress scale - 21 items( DASS-21) |
at the beginning of study and at the end that is at start and 6th week of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
31/07/2025 |
| 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="1"
Months="6"
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
|
This study focuses on evaluating the effectiveness of structured exercise program compared to home based aerobic exercise program in improving quality of life , depression , anxiety and stress in women with diagnosed endometriosis. women with endometriosis experiences higher levels of stress, anxiety and depression, which can negatively affect their quality of life. while home based aerobic exercise is known to reduce these symptoms, many women face barriers to regular physical activity. where as structured exercise program including breathing exercise, stretching , core stability exercises and pelvic floor training may offer similar benefit without side effect of medication or the challenge of daily exercise, making it a promising alternative therapy.
38 participants will be included and everyone will be given a sequential number. then the participants will be randomly divided into two groups by computer random generated number list.
Each group will have 19 participants each.
Group A will be intervention group receiving a structured exercise program including stretching, breathing exercise, core stability exercise and pelvic floor exercises.
Group B will be control group receiving home based aerobic exercise.
The protocol will be of 45 mins thrice a week for 6 weeks.
Endometriosis health profile - 30 , Depression, anxiety and stress scale-21 items are the outcome measures which will be taken before and 6 weeks of intervention. |