| CTRI Number |
CTRI/2018/02/011693 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of breathing exercise in respiratory problems |
|
Scientific Title of Study
|
Effects Of Breathing Exercises On acute exacerbation of COPD to redu ce Anxiety And Depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Joy |
| Designation |
Post graduate student |
| Affiliation |
Manipal University |
| Address |
Deparment of Physiotherapy #98, Old Airport Road Manipal hospital
Opposite Leela Palace
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9916148467 |
| Fax |
|
| Email |
sneha4joy1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prem V |
| Designation |
Associate professor |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy
Manipal Hospital
Old airport road
HAL
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prem V |
| Designation |
Associate professor |
| Affiliation |
Manipal University |
| Address |
Department of physiotherapy
Manipal Hospital
Old airport road
HAL
Bangalore
KARNATAKA
560017
India |
| Phone |
|
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| School of allied Health Sciences,Department of physiotherapy, Manipal hospital,Manipal University, Bangalore |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Deparment of Physiotherapy, School of Allied Health sciences, #98, Old Airport Road Manipal hospital,
Bangalore. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sneha L Joy |
Manipal University |
Deparment of
Physiotherapy,School of allied Health Sciences, Old
Airport Road, Manipal
hospital
Bangalore
KARNATAKA |
9916148467
sneha4joy1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, School of Allied health Sciences, Manipal University, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Exacerbation of COPD, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing Exercises |
Pursed lip breathing exercise
Diaphragmatic breathing exercise |
| Comparator Agent |
Pharmacological |
Standard Pharmacological drug |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Acute exacerbation of COPD patients
2. 48hrs Post exacerbation
3. Either gender between the 40 – 85 years
4. Hospital anxiety and depression score >7
5. Moderate to severe COPD patients
|
|
| ExclusionCriteria |
| Details |
1. Stable COPD patients
2. Presence of previous history of respiratory disorders such as pneumonia, TB, bronchiectasis
3. Intubated patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hospital Anxiety Depression Scale |
Baseline
4th week
8th week
12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Respiratory Rate
Oxygen Saturation
Patient Preference Rating |
Baseline
4th week
8th week
12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2016 |
| Date of Study Completion (India) |
10/02/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study concludes that breathing exercise is effective in reducing anxiety, depression, respiratory rate, length of hospital stay and improves oxygen saturation in acute excerbation of COPD |