| CTRI Number |
CTRI/2017/12/010952 [Registered on: 21/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
17/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Breathing exercises to improve the strength of respiratory muscles in COPD population |
|
Scientific Title of Study
|
Effect of Inspiratory muscle training on respiratory muscle strength in COPD subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Veena Kiran Nambiar |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals |
| Address |
Dept of Physiotherapy,Ramaiah Medical College and Hospitals,MSR Nagar,MSRIT -post,Bangalore-
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
080-23608361 |
| Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Kiran Nambiar |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals |
| Address |
Dept of Physiotherapy,Ramaiah Medical College and Hospitals,MSR Nagar,MSRIT -post,Bangalore-
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
080-23608361 |
| Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Veena Kiran Nambiar |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospitals |
| Address |
Dept of Physiotherapy,Ramaiah Medical College and Hospitals,MSR Nagar,MSRIT -post,Bangalore-
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
080-23608361 |
| Email |
veenakiran_nambiar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| 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 |
| Dr Veena Kiran Nambiar |
Ramaiah Medical College |
Centre for rehab,Ramaiah memorial hospital,MSR nagar
Bangalore
Bangalore
KARNATAKA |
9880575407
veenakiran_nambiar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah medical college and hospital,ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
COPD Subjects, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparator group |
Pulmonary Rehabilitation |
| Intervention |
Inspiratory muscle training Group |
Combined with Pulmonary rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed COPD subjects
|
|
| ExclusionCriteria |
| Details |
Female COPD subjets,Those unable to comprehend |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respiratory muscle strength,six minute walk distance and chronic respiratory disease questionnaire. |
Respiratory muscle strength,six minute walk distance and chronic respiratory disease questionnaire. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Adding an inspiratory muscle training program to pulmonary rehabilitation could bring about an improvement in respiratory muscle strength,six minute walk distance and quality of life as compared to pulmonary rehabilitation alone in male COPD subjects. |