FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
nil   
 
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  
Status 
Not Applicable 
 
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.

 
Close