| CTRI Number |
CTRI/2025/03/082926 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Diaphragm breathing training programme in obese individuals |
|
Scientific Title of Study
|
Effect of Diaphragm breathing training programme on limits of stability and diaphragm excursion in obese individuals - An Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shradha Sawant |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Exercise Physiology Fitness lab(EPFL)
K J Somaiya College of Physiotherapy, Everard Nagar, Eastern Express Highway, Sion, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9987154918 |
| Fax |
|
| Email |
shradhasawant18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shradha Sawant |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Exercise Physiology Fitness lab(EPFL)
K J Somaiya College of Physiotherapy, Everard Nagar, Eastern Express Highway, Sion, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9987154918 |
| Fax |
|
| Email |
shradhasawant18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shradha Sawant |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Exercise Physiology Fitness lab(EPFL)
K J Somaiya College of Physiotherapy, Everard Nagar, Eastern Express Highway, Sion, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9987154918 |
| Fax |
|
| Email |
shradhasawant18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Exercise Physiology Fitness lab K J Somaiya College of Physiotherapy, Eastern express Highway,Sion, mumbai, Maharashtra
Department of radiology, K J Somaiya medical College, Eastern express Highway, Sion mumbai, Maharashtra 400022 |
|
|
Primary Sponsor
|
| Name |
Shradha Sawant |
| Address |
Flat no 603, Tricity Promenade, Sector 38, Seawoods, Navi Mumbai, 400706 |
| Type of Sponsor |
Other [Other [Self]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| K J Somaiya College of Physiotherapy |
Everard Nagar, Eastern Express Highway, Sion, Mumbai 400022 |
| Parul University Faculty of Physiotherapy |
P.O.Limda, Waghodia, Vadodara, Gujarat 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shradha Sawant PT |
K J Somaiya College of Physiotherapy |
Exercise Physiology Fitness lab, K J Somaiya College of Physiotherapy Everard Nagar, Eastern Express Highway, Sion, Mumbai 400022
Mumbai (Suburban)
MAHARASHTRA |
9987154918
shradhasawant18@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| K J Somaiya Medical College and Hospital, Mumbai, Institutional Ethics Committee (Academic) |
Approved |
| K J Somaiya Medical College and Hospital, Mumbai, Institutional Ethics Committee (Academic) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
6 weeks of conventional balance physiotherapy exercises (for Control group) |
frequency 5 days /week. After initial baseline assessment following would be followed 1.Balance exercises for 30 minutes would be given |
| Intervention |
6 weeks of diaphragmatic breathing training programme |
frequency 5days/week. After baseline initial assessment each participant will follow the following protocol. 1. Diaphragmatic breathing exercises. 2. Diaphragmatic strengthening 3.Activation of diaphragm with core. 4. Diaphragm flexibility with movements. 5 Diaphragm Scoop technique |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI more than 30kg/m2
2. Participants with score less than 35 on bergs balance scale
3. IPAQ score low level of physical activity |
|
| ExclusionCriteria |
| Details |
1. Any neurological conditions
2. Acute musculoskeletal problems
3. Spine surgeries
4. Any cardio respiratory conditions
5. Participants should not be under any physical training programme for minimum six months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Limits of stability -sway, centre of progression, tandem walk
2. Diaphragm excursion
|
1. Baseline measurement taken before starting the interventions
2.After 6 weeks completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Lung function test- PFT |
1.Baseline measurement taken before starting the interventions.
2. After 6 weeks completion of intervention |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
02/06/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1. Participants will be recruited based on inclusion and exclusion criteria and only after informed consent is obtained. 2. Baseline assessments would be done followed by grouping as per random allocation and intervention will be started 3. Protocol as per the two groups would continue for 6 weeks followed by repeat assessments. 4. The data obtained would be analysed and appropriate statistical test would be applied and based on the results conclusion would be drawn and discussed along with limitations of the study and suggestions for future research. |