| CTRI Number |
CTRI/2025/09/094149 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Treshold training and biofeebback training given for COPD improves the morphological changes and strengthens the respiratory muscles of the same |
|
Scientific Title of Study
|
THRESHOLD TRAINING VERSUS BIOFEEDBACK TRAINING ON MORPHOLOGICAL CHANGES IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
| Trial Acronym |
TTBT- COPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Sathya |
| Designation |
Assistant professor |
| Affiliation |
MMM college of health sciences |
| Address |
Flat no:2 B, vgn olive creek, 3rd main road, vgn mahalakshmi nagar, thiruverkadu, Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9677082942 |
| Fax |
|
| Email |
sathyammm2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jibi Paul |
| Designation |
Professor, supervisor PhD program |
| Affiliation |
Faculty of Physiotherapy Dr. MGR educational and research institute, |
| Address |
Dr. MGR educational and research institute,
Faculty of Physiotherapy,
Velappanchavadi,
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9061470448 |
| Fax |
|
| Email |
physiojibi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jibi Paul |
| Designation |
Professor, supervisor PhD program |
| Affiliation |
Faculty of Physiotherapy Dr. MGR educational and research institute, |
| Address |
Dr. MGR educational and research institute,
Faculty of Physiotherapy,
Velappanchavadi,
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9061470448 |
| Fax |
|
| Email |
physiojibi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM COLLEGE OF HEALTH SCIENCES, EAST MOGAPPAIR, CHENNAI- 600107 |
|
|
Primary Sponsor
|
| Name |
S. SATHYA |
| Address |
MMM COLLEGE OF HEALTH SCIENCES, EAST MOGAPPAIR, CHENNAI- 600107 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Sathya Suriyamoorthy |
ACS MEDICAL COLLEGE AND HOSPITA |
Ponamallee high road, Velappanchavadi, Chennai- 600077
Chennai
TAMIL NADU |
09677082942
sathyammm2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics committee, Dr. M.G.R Educational and research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Incentive spirometry and pused lip breathing exercise |
Incentive spirometry- 10 repititions twice daily for 12 weeks and pursed lip breathing exercise for 15 minutes per day for 12 weeks |
| Intervention |
Threshold training |
Threshold training given for 45 mins 4 times a week for 12 weks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Day(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Stable moderate COPD subjects both male and female under the age group of 45-65 years, FEV1/FVC RATIO 60-59% |
|
| ExclusionCriteria |
| Details |
Subjects with severe COPD and chest infections, severe or unstable cardiac diseases, recent thoracic surgeries and severe exacerbation |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary functions using Spirometer and morphological changes in lungs using CT scan |
Pulmonary functions and morphological changes in lungs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inspiratory muscle strength and quality of life |
Inspiratory muscle strength and quality of life |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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 Yet Recruiting |
| 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 experimental study aims to evaluate the effects of threshold training, biofeedback training and conventional training on improving the morphological changes in subjects with stable moderate COPD aged 45-65 years. The study will be conducted at the out patient department of Faculty of physiotherapy, department of pulmonology, ACS medical college and hospital, which involves 126 both male and female subjects divided into three groups with 42 participants in each group, undergoing 45 minute sessions four times weeekly over a period of 12 weeks. The primary aim is to investigate the effectiveness of these interventions in improving the morphological changes and pulmonary functions among the copd subjects. The primary objective being a comparitive analysis of threshold training versus biofeedback training on morphological changes in copd. Secondary objectives includes assesing the individual effects of each intervention like threshold trainin, biofeedback training and conventional training on these parameters. Outcome measures encompass lung functions, inspiratory muscle strength, morphological changes in lungs and quality of life. The results will be revealed after the intervention period and its intended to identify the most effective physiotherapy approach for improving the lung condition and functional capacity in subjects with copd. |