| CTRI Number |
CTRI/2013/05/003610 [Registered on: 06/05/2013] Trial Registered Prospectively |
| Last Modified On: |
06/05/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of breathing muscle training for asthmatics |
|
Scientific Title of Study
|
Effectiveness of Inspiratory muscle training in patients with mild to severe asthma |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IRB Min.No:7952 dated 22.08.2012 |
NIL |
| other |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subashini K |
| Designation |
Tutor Grade IV(PT) |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine
CMC
Vellore
Mobile -9840447517
Department of Pulmonary Medicine
CMC
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
09840447517 |
| Fax |
04162211570 |
| Email |
subanappi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subashini K |
| Designation |
Tutor Grade IV(PT) |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine
CMC
Vellore
Mobile -9840447517
Department of Pulmonary Medicine
CMC
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
09840447517 |
| Fax |
04162211570 |
| Email |
subanappi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Subashini K |
| Designation |
Tutor Grade IV(PT) |
| Affiliation |
Christian Medical College |
| Address |
Department of Pulmonary Medicine
CMC
Vellore
Mobile -9840447517
Department of Pulmonary Medicine
CMC
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
09840447517 |
| Fax |
04162211570 |
| Email |
subanappi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board Department of Pulmonary Medicine |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board |
| Address |
Christian Medical College
Vellore
Tamilnadu
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Subashini K |
Department of Pulmonary Medicine |
Christian Medical College
Vellore Vellore TAMIL NADU |
09840447517 04162211570 subanappi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,Christian Medical College(CMC),Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Threshold inspiratory muscle trainer without resistance |
Control group(placebo training) will receive sham training with the threshold inspiratory muscle trainer without resistance for a period of 6 weeks. |
| Intervention |
Threshold inspiratory muscle trainer(respiratory muscle exerciser) with resistance for a period of 6 weeks. |
Threshold inspiratory muscle trainer is a respiratory muscle exerciser and not a drug.Threshold inspiratory muscle trainer is a device which has a spring loaded valve,requiring the patient to inspire hard enough to open the valve and permit inspiration against that force.The opening pressure (resistance) may be adjusted and can be tailored for the individual.The study group will receive specific inspiratory muscle training (SIMT) with a threshold inspiratory muscle trainer with the resistance increased incrementally. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of mild to severe asthma according to GINA guidelines
2. Age 30 to 65 years
3. Symptomatic – Dyspnoea
4. Patients referred by the Physicians for Inspiratory muscle training
|
|
| ExclusionCriteria |
| Details |
1. Patients who are deemed to be too sick to perform the 6 min walk test or other study related tests.
2. The presence of a significant comorbid disease that might interfere with the training process or place the patient at undue risk for exercise training
3.Inspiratory muscle training within the past 12 months.
4.Subjects unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PI max-Measurement of the maximum static Inspiratory pressure that a subject can generate at the mouth (PImax) is a simple way to gauge inspiratory muscle strength |
PI max-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PE max,6 minute walk test,Asthma Control test,St.George Respiratory Disease Questionnaire |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
13/05/2013 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
once the study is completed,it will be published in a reputed journal.
Subashini.K,Dr.Balamugesh.T,
Dr.D.J.Christopher,Daisy Rose Mary.T
Few studies for reference are listed below
1.Weiner P, Berar-Yanay N, Davidovich A, Magadle R, Weiner M.Specific inspiratory muscle training in patients with mild asthma with high consumption of inhaled beta(2)-agonists.Chest 2000;117(3):722–727.
2.Weiner P, Azgad Y, Ganam R,WeinerM. Inspiratory muscle training in patients with bronchial asthma. Chest 1992;102(5):1357–61
3.Influence of Gender and Inspiratory MuscleTraining on the Perception of Dyspnea in Patients With Asthma Paltiel Weiner, Rasmi Magadle, Fareed Massarwa, Marinella Beckerman and Noah Berar-Yanay Chest 2002;122;197-201
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mild to severe asthmatics who satisfy the study criteria will be consented and randomly allocated into 2 groups-the study group (76 patients) who will receive specific inspiratory muscle training(IMT) and the control group (76 patients). Subjects in both groups will be trained with 2 supervised sessions during the first week, followed by one supervised session per week for a period of 6 weeks, with each session consisting of 0.5 h of training. The subjects in study group will receive specific inspiratory muscle training (SIMT) with a threshold inspiratory muscle trainer. The subjects will start breathing at a resistance level equal to 30% of their PI max for 1 week. They will be instructed to use the trainer at home for half an hour, daily. The resistance will be increased incrementally, by 5 to 10% each supervised session. Patients in group B will receive sham training with the threshold inspiratory muscle trainer with no resistance and they will also have weekly supervised session. All patients will receive standard pharmacotherapy prescribed by the Physician. An informed consent will be obtained from each patient.
Assessments will be made before and immediately after 6 weeks of training. Asthma control will be measured using Asthma Control Test (ACT)and quality of life will be measured using St. George Respiratory Disease Questionnaire(SGRQ). Patients will maintain an asthma diary for daily symptoms and PEFR will be measured. Lung function test will be performed using a computerized Spirometry and respiratory muscle strength will be assessed by measuring the maximal inspiratory mouth pressures (PI max). The test would be performed using Jaeger Viasys 5.0 system as per American Thoracic Society(ATS) criteria. The 6 minute walk test will be administered in a 30 m corridor in accordance with the guidelines recommended by ATS. |