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CTRI Number  CTRI/2024/03/064183 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of deep breathing exercise in Chronic Obstructive Pulmonary Disease (COPD). 
Scientific Title of Study   Effect of deep breathing exercise along with pharmacotherapy in COPD Assessment Test score (CAT score) as compared to pharmacotherapy alone in patients with mild to moderate chronic obstructive pulmonary disease attending a tertiary care center in south Kerala. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jithin J 
Designation  Junior Resident 
Affiliation  Pushpagiri Institute of Medical Sciences and Research Center. 
Address  Junior Resident Department of Physiology Pushpagiri Institute of Medical Sciences and Research Center Thiruvalla, Pathanamthitta Kerala

Pathanamthitta
KERALA
689101
India 
Phone  8281972167  
Fax    
Email  drjithinjpillai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikram Gowda NR 
Designation  Professor and HOD 
Affiliation  Pushpagiri Institute of Medical Sciences and Research Center. 
Address  Professor and HOD Department of Physiology Pushpagiri Institute of Medical Sciences and Research Center Thiruvalla, Pathanamthitta Kerala

Pathanamthitta
KERALA
689101
India 
Phone  9562947479  
Fax    
Email  vikramgowda2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jithin J 
Designation  Junior Resident 
Affiliation  Pushpagiri Institute of Medical Sciences and Research Center. 
Address  Junior Resident Department of Physiology Pushpagiri Institute of Medical Sciences and Research Center Thiruvalla, Pathanamthitta Kerala

Pathanamthitta
KERALA
689101
India 
Phone  8281972167  
Fax    
Email  drjithinjpillai@gmail.com  
 
Source of Monetary or Material Support  
Pushpagiri Institute of Medical sciences and research center. 
 
Primary Sponsor  
Name  Dr Jithin J 
Address  Junior Resident Department of Physiology Pushpagiri Institute of Medical Sciences and Research Center Thiruvalla, Pathanamthitta Kerala 
Type of Sponsor  Other [Primary Investigator] 
 
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 Jithin J  Pushpagiri Institute of Medical Sciences and Research Center   Junior Resident Department of Physiology Pushpagiri Institute of Medical Sciences and Research Center Thiruvalla, Pathanamthitta Kerala
Pathanamthitta
KERALA 		 8281972167

drjithinjpillai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pushpagiri Institute of Medical Sciences and Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deep breathing exercise  Deep breathing exercises include - alternate nostril breathing and pursed lip breathing. These are added as behavioral change to COPD patients on pharmacotherapy. Duration - 6 weeks 
Comparator Agent  NIL  COPD patients on regular pharmacotherapy. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  COPD patients with mild to moderate disease undergoing regular pharmacotherapy. 
 
ExclusionCriteria 
Details  Patients on treatment for cardiovascular or renal diseases.
Patients having musculoskelatal abnormalities of chest wall. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Difference in CAT score between two groups.  Six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in blood pressure and heart rate values between two groups.  Six weeks 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 3 
Date of First Enrollment (India)   27/03/2024 
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)   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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Rationale -
Deep breathing exercises (DBE) have shown betterment of pulmonary function in COPD patients. Previous studies have proposed DBE as an adjunct treatment in COPD. But in the majority of them,  the time range of exercise is not fixed, which can cause subjective change in exercise performance.  By this study we are aiming to elucidate the effect of Deep Breathing Exercise (DBE) with a fixed time limit on each cycle in stable COPD patients, with the help of COPD assessment test score (CAT). By fixing the time range of exercise , it’s expected to eliminate subjective errors in  performing the same.

Research question

  1. Is Deep breathing exercise (DBE) along with pharmacotherapy, better than pharmacotherapy alone in improving  CAT score among patients with mild to moderate COPD.

  2. Is DBE along with pharmacotherapy, better than pharmacotherapy alone in improving cardiovascular function among patients with mild to moderate COPD.


Objectives -

Primary objective: To compare CAT score of COPD patients receiving DBE and pharmacotherapy; with COPD patients receiving pharmacotherapy alone after 4 weeks of DBE.

Secondary objectives: To compare cardiovascular parameters of COPD patients receiving DBE and pharmacotherapy; with COPD patients receiving pharmacotherapy alone after 4 weeks of DBE.

Methodology

Chronic Obstructive Pulmonary Disease - COPD patients fulfilling inclusion and exclusion criteria and giving consent will be randomly allotted to interventional and control groups using block randomisation method. Allocation concealment will be done using sealed envelope technique. Initial values of CAT score, blood pressure and heart rate are recorded.
The interventional group will be given training on deep breathing exercises - alternate nostril breathing exercise and pursed lip breathing exercise. Subjects will be monitored to assure that they perform these exercises for 10 minutes twice daily for a period of 4 weeks.
At the end of 4 weeks difference in final values between two groups will be compared as - 1) Difference in CAT score, 2) Difference in blood pressure, 3) Difference in heart rate by suitable statistical tests.


 
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