| CTRI Number |
CTRI/2023/08/056978 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of respiratory muscle training on functional capacity, breathing difficulty & heart function in people with chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
Effect of Inspiratory Muscle Training on Exercise Capacity, Dyspnea & Cardiac Autonomic Function in Individuals with Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Sharma |
| Designation |
Postgraduate student |
| Affiliation |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences |
| Address |
Institution of Rehabilitation Sciences, Department of Physiotherapy, Sector-C, Vasant Kunj
New Delhi, Delhi
South West
DELHI
110070
India |
| Phone |
9560115595 |
| Fax |
|
| Email |
30shikhasharma.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha Sharma |
| Designation |
Postgraduate student |
| Affiliation |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences |
| Address |
Institute of Rehabilitation Sciences, Department of Physiotherapy, Sector-C, Vasant Kunj
New Delhi, Delhi
South West
DELHI
110070
India |
| Phone |
9560115595 |
| Fax |
|
| Email |
30shikhasharma.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shambhovi Mitra |
| Designation |
Associate Professor |
| Affiliation |
Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences |
| Address |
Institute of Rehabilitation Sciences, Department of Physiotherapy, Sector-C, Vasant Kunj
New Delhi, Delhi
South West
DELHI
110070
India |
| Phone |
9711968166 |
| Fax |
|
| Email |
shams.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Department of Physiotherapy, Sector-C, Vasant Kunj, New Delhi, Delhi |
|
|
Primary Sponsor
|
| Name |
IndianSpinal Injuries Centre- Institute of Rehabilitation Sciences |
| Address |
Sector-C, Vasant Kunj, New Delhi-110070 |
| 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 |
| Shikha Sharma |
National Institute of Tuberculosis and Respiratory Diseases (NITRD) |
Sri Aurobindo Marg, Near Qutub Minar, New Delhi-110030
NITRD hospital, OPD wing, 3rd floor, Exercise room
South West
DELHI |
9560115595
30shikhasharma.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Inspiratory muscle training |
Inspiratory muscle training via threshold resistance IMT, three times a week along with pulmonary rehabilitation for eight weeks. |
| Comparator Agent |
Sham training |
Sham training along with pulmonary rehabilitation, three times a week for eight weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
GOLD classification of COPD: moderate to severe
Inspiratory muscle weakness ( PI max< 70 cm H2O) |
|
| ExclusionCriteria |
| Details |
Subjects on mechanical ventilators,
Subjects with acute myocardial infarction within 3 months before inclusion,
Diagnosed history of unstable angina and unstable ventricular arrhythmia within the last 3 months prior to initiation,
Subjects with acute respiratory disease other than COPD, rheumatoid disease, and degenerative disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exercise capacity will be assessed by six-minute walk distance calculated measured by six-minute walk test |
Six-minute walk distance will be measured at baselines and after 8 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dyspnea will be assessed by baseline & transition dyspnea index scale & Cardiac autonomic function will be assessed by heart rate variability |
Secondary outcomes will be assessed at the baseline before allotment & at the end of 8 weeks of intervention training |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
26/09/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized, double-blind, parallel group, single-centre trial to determine the effect of inspiratory muscle training on exercise capacity, dyspnea and cardiac autonomic function in individuals with COPD. The recruited subjects will be randomized in two-groups: group-A (experimental group) and group-B (control group). Group-A will be given inspiratory muscle training and pulmonary rehabilitation and group-B will be given sham training and pulmonary rehabilitation, three times a week for eight weeks. The primary outcome is exercise capacity, will be measured with six-minute walk distance, secondary outcomes are dyspnea and cardiac autonomic function will be measured with rate of perceived exertion and heart rate variability respectively. The outcomes will be assessed at time points T0 (at the time of allotment) and T1 (after the training). |