| CTRI Number |
CTRI/2023/04/051427 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
"Immediate effect of respiratory muscle stretch and pursed lip breathing exercise on thoracic expansion and pulmonary function on mild to moderate COPD subjects-a comparative study" |
|
Scientific Title of Study
|
"IMMEDIATE EFFECT OF INTERCOSTAL STRETCH AND PURSED LIP BREATHING EXERCISE ON THORACIC EXPANSION AND PULMONARY FUNCTION ON MILD TO MODERATE COPD SUBJECTS -A COMPARATIVE STUDY" |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruvikaben Rathod |
| Designation |
MPT SCHOLER |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Parul University,p.o.limda,Ta.waghodia, vadodara
Parul University,Po.limda,Ta. Waghodia,Dist. Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
07434868650 |
| Fax |
91-2668-260201 |
| Email |
dhruvikarathod28699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDidhiti Desai |
| Designation |
Assistant professor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Parul University,parul institute of physiotherapy,Po. Limda,Ta.waghodia,Dist. Vadodara
Vadodara
GUJARAT
390022
India |
| Phone |
8866458302 |
| Fax |
91-2668-260201 |
| Email |
Didhiti.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dhruvikaben Rathod |
| Designation |
MPT SCHOLER |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Parul University,parul institute of physiotherapy,po.limda,Ta.waghodia,Dist.vadodara
Vadodara
GUJARAT
390022
India |
| Phone |
07434868650 |
| Fax |
91-2668-260201 |
| Email |
dhruvikarathod28699@gmail.com |
|
|
Source of Monetary or Material Support
|
| Respiratory medicine,room no-12,ground floor, parul sevashram hospital |
|
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Primary Sponsor
|
| Name |
Parul sevashram hospital |
| Address |
P.o. limda,Ta.waghodia,Dist.vadodara |
| Type of Sponsor |
Private hospital/clinic |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhruvikaben Rathod |
Parul sevashram hospital , Respiratory medicine department,room no:12 |
P.O.Limda,Tal: waghodia,Dist: vadodara
Vadodara
GUJARAT |
07434868650
91-2668-260201
dhruvikarathod28699@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University institutional ethics committee for Human Research (PU-IECHR) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intercostal stretch, pursued lip breathing, Thoracic expasion exercise |
Immediate effect of intercostal stretch and thoracic expasion exercise on mild to moderate COPD subject.
Immediate effect of pursed lip breathing and thoracic expasion exercise on mild to moderate COPD subject. |
| Intervention |
Pursed lip breathing, intercostal stretch, thoracic expansion exercises |
Thoracic expasion exercise (15 minutes breathing exercises with 5 minutes of rest after 2 minutes of bretah)
Intercostal stretch ( 10 breaths with 1 minutes rest for 10 repetitions)
Pursed lip breathing ( 10 repetitions with 5 min rest for 3 set) |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females of age is between 40 to 60.
Patient with mild, moderate airway obstruction based on gold criteria: gold 1-(mild: fev1 /fvc < 0.70, FEV1> 80% of predicted) gold 2 -(moderate: FEV1 /FVC < 0.70, 50% < FEV1< 80% of predicted).
Medically diagnosed COPD patient.
Willing to participate.
smokers or ex-smokers of more than 10 pack-years, and symptoms suggestive of COPD.
|
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable subjects.
Patients with severe orthopedic problems related to spine, fracture of rib, sternum fracture, neurological deficits, affecting the respiratory muscles, unstable cardiac condition, recent myocardial infarction, intercostal muscles strain.
Previous lung – volume reduction surgery, lung transplantation or pneumonectomy
Patient is having history of core pulmonale
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
•pre(pulmonary function (FEV1, FVC, FEV1/FVC)
•Chest expansion (tape method)
Post after the intervention
|
45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
0 |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
17/04/2023 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
IMMEDIATE
EFFECT OF INTERCOSTAL STRETCH AND PURSED LIP BREATHING EXERCISE ON THORACIC
EXPANSION AND PULMONARY FUNCTION ON MILD TO MODERATE COPD SUBJECTS – A
COMPARATIVE STUDY. AIM: To compare the immediate effect of intercostal stretch along with thoracic expansion exercise and pursed lip breathing along with thoracic expansion exercise on pulmonary function and thoracic expansion on mild to moderate COPD subjects. OBJECTIVES: · To determine the immediate effect of intercostal stretch along with thoracic expansion exercise on FEV1, FVC, FEV1/FVC on mild to moderate COPD subjects. - To determine the immediate effect of intercostal stretch along with thoracic expansion exercise on thoracic expansion on mild to moderate COPD subjects.
- To determine the immediate effect of pursed lip breathing along with thoracic expansion exercise on FEV1, FVC, FEV1/FVC on mild to moderate COPD subjects.
- To determine the immediate effect of pursed lip breathing along with thoracic expansion exercise on thoracic expansion on mild to moderate COPD subjects.
- To compare the immediate effect of inter costal stretch along with thoracic expansion exercise and pursed lip breathing along with thoracic expansion exercise on thoracic expansion on mild to moderate COPD subjects.
- To compare the immediate effect of inter costal stretch along with thoracic expansion exercise and pursed lip breathing along with thoracic expansion exercise on FEV1, FVC, FEV1/FVC on mild to moderate COPD subjects.
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