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CTRI Number  CTRI/2018/01/011501 [Registered on: 23/01/2018] Trial Registered Retrospectively
Last Modified On: 19/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Breathing Techniques]  
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to find out the effect of three breathing techniques on quality of life and outcome among chornic obstructive pulmonary disease (COPD) patients  
Scientific Title of Study   Effectiveness of Pulmonary Interventions(PI) on Health Related Quality of Life (HRQL) and Clinical outcomes(CO) among Chornic Obstructive Pulmonary Disease (COPD) patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Flavia Castelino 
Designation  PhD Scholar (External) 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Medical Surgical Nursing MCON, MAHE Manipal
Department of Medical Surgical Nursing Manipal College of Nursing Manipal MAHE
Udupi
KARNATAKA
576107
India 
Phone  9902558332  
Fax    
Email  castelinoflavia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukhyprana Prabhu  
Designation  Professor and Unit chief 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Medicine Kasturba Hospital MAHE Manipal
Manipal Udupi taluk and district mmukhyaprana@yahoo.com
Udupi
KARNATAKA
576104
India 
Phone  9632118700  
Fax    
Email  mm.prabhu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Flavia Castelino 
Designation  PhD Scholar (External) 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Medical Surgical Nursing Manipal College of Nursing Manipal MAHE

Udupi
KARNATAKA
576107
India 
Phone  9902558332  
Fax    
Email  castelinoflavia@gmail.com  
 
Source of Monetary or Material Support  
Flavia Castelino Department of Medical Surgical Nursing MCON, MAHE, Manipal 
 
Primary Sponsor  
Name  Flavia Castelino 
Address  Department of Medical Surgical Nursing Manipal College of Nursing Manipal MAHE  
Type of Sponsor  Other [Self ] 
 
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 
Flavia Castelino  Kasturba Hospital Manipal   department are Pulmonary and Medicine. Room numbers MM3 MM5 MM8 MF3 and P wards. Devisions are pulmonary and medical units.
Udupi
KARNATAKA 		 9902558332

castelinoflavia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Obstructive Pulmonary Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group  standard care alone 
Intervention  Pulmonary Interventions(PI)  pulmonary interventions are pursed lip breathing tec hnique, diaphragmatic breathing technique and incentive spirometry  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 Patients with mild to moderate COPD, admitted in the wards.
2 Age 40 years and above
3 Both males and females
 
 
ExclusionCriteria 
Details  The COPD patients those who are,
1. in acute exacerbation
2. with severe dyspnea.
3. mentally ill and who have participated in any pulmonary rehabilitation program for the past 6 months.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Health Related Quality of Life(HRQL)  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Outcome (CO)  6 months  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/01/2016 
Date of Study Completion (India) 15/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Socio-demographic and clinical characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients in Manipal Journal of Nursing and Health Sciences | July 2017 | Volume 3 | Issue 2 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Chronic Obstructive Pulmonary Disease (COPD) is a crucial health issue and ranks fifth in the global burden of disease. Even though the disease is identified by the symptoms of intensified respiratory manifestations and decline in functional status, exacerbation gives rise to the substantial threat for morbidity and early mortality. COPD also has a considerable influence on quality of life and is the noteworthy cause of health care associated expenses. This study is descriptive analysis of the socio-demographic and clinical variables among COPD patients in a tertiary referral hospital. Objective: The objective of this study is to assess the socio-demographic variables and clinical variables of COPD patients. Methods: This study is a part of Randomized Control Trial (RCT) on “Effectiveness of Pulmonary Interventions on Health Related Quality of Life and Clinical Outcome among COPD patients.” Data were collected using Socio-demographic proforma and clinical proforma. Results: Analysis shows that the majority were males 127 (90.7%) aged around 61-86 years (62.14%) and the highest numbers of men were smokers (85.7%). Conclusion: Understanding the sociodemographic variables and the clinical variables of patient with COPD is essential in the treatment of COPD.


 
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