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CTRI Number  CTRI/2024/09/073655 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 08/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of Expiratory Muscle training on Cough strength, Respiratory Muscle Strength and ability for activities in daily living in individuals with long term lung disease with narrowed airways. 
Scientific Title of Study   Effects of Expiratory Muscle Training on Peak Cough Flow, Respiratory Muscle Strength and Functional capacity in individuals with Chronic Obstructive Airway Disease: A Single Blinded Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachna Arora 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  Room No. 4, OPD-24 (M building), Physiotherapy department, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai, MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  7738095911  
Fax    
Email  rachna2arora@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rachna Arora 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  Room No. 4, OPD-24 (M building), Physiotherapy department, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai, MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  7738095911  
Fax    
Email  rachna2arora@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kanchan Deshmukh 
Designation  Post Graduate student 
Affiliation  Topiwala National Medical College and Dr B.Y.L. Charitable Hospital 
Address  Room No. 4, OPD-24 (M building), Physiotherapy department,Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai, MAHARASHTRA

Mumbai
MAHARASHTRA
400008
India 
Phone  7038112625  
Fax    
Email  kanchandeshmukh65@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai Maharashtra 400008 India 
 
Primary Sponsor  
Name  NIL 
Address  NIL  
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachna Arora  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  Room No. 4, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
7738095911

rachna2arora@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  This will include 3 sets of Active Cycle of Breathing exercise (ACBT) It consists of three main phases: 1. Breathing Control 2. Thoracic Expansion Exercises 3. Huffing or Forced Expiratory Technique (FET) Breathing Control: The Participant will be seated comfortably in a Chair. He / She will be instructed to breathe in gently through the nose according to his / her own rate and breathe out through the mouth by pursing the lips. The Participant will be made to perform 6 breaths of Breathing Control. Thoracic Expansion Exercises: His / her hands will be placed over the lower chest wall in the mid-axillary line. Keeping the Shoulders relaxed, the participant will be instructed to take a long, slow and deep breath in through the nose, hold the air in the lungs for 2 – 3 seconds (inspiratory hold) before breathing out gently and relaxed like a sigh. The participant should not force the air out. Repeat 5 times. Forced Expiratory Technique: A Huff is exhaling through an open mouth and throat instead of coughing. Huffing helps moves sputum from the small airways to the larger airways, from where they are removed by coughing. Only perform 1-2 huffs together. The overall duration required for this procedure will be 12-15minutes.  
Intervention  Expiratory muscle training with conventional physiotherapy   The participant will be instructed to take a deep breath, place the mouthpiece of the device in such a way to form a tight seal around it and breathe out as hard and fast as they can into the device. The Protocol will include a total of 25 such breaths per session. After each breath, a rest interval of 15 – 20 seconds will be given and after every 5 breaths(1set) a rest interval of 1 minute will be given. 5 set of such breaths will be performed. The duration for expiratory muscle training will be approximately 15 to 20 minutes. If a Participants Oxygen Saturation levels fall below 90% during the training, the rest interval between the breaths will be increased and where necessary low flow oxygen supplementation will be given. The resistance will be increased by 1 every week, if participants can perform easily, otherwise the same procedure will follow. Along with this Conventional Physiotherapy will be given. Total duration for this treatment session will be approximately 25-30minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with moderate to severe Obstructive Airway Disease by chest physician. 
 
ExclusionCriteria 
Details  1) Resting RR more than 30 bpm
2) Resting HR more than 120 bpm
3) Resting SBP less than 100 and more than 140 mm Hg
4) Resting DBP more than 100 mmHg
5) Patients diagnosed with any Cardiac disease by Cardiologist.
6) Patients on Oxygen therapy.
7) Patients who are incapable of performing the expiratory muscle training.
8) Patients who are not willing to participate. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Cough Strength in L/min using Peak Cough Flow Meter
2)Maximum Inspiratory Pressure and Maximum Expiratory Pressure in cm H2O using Respiratory Pressure Meter
3) 6 Minute Walk Distance (6MWD) in meters from 6 Minute Walk Test
(6MWT) 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   30/09/2024 
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)  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   NEED OF STUDY
In obstructive lung disease, factors such as inflammation, bronchoconstriction, excessive mucus, and decreased elastic recoil lead to an earlier small airway closure during expiration and more significant airway resistance.18 This results in greater work of breathing. Studies have shown that not only inspiratory muscle dysfunction but even expiratory muscle dysfunction is seen in patients with COPD. The weak expiratory muscles result in insufficient force to move the mucus or other secretions proximally to clear the airways, thereby increasing the risk of infections and exacerbations17. Weakened expiratory muscles contribute to ineffective exhalation, resulting in air trapping within the lungs (hyperinflation) and reduced ability to fully empty the lungs during breathing cycles.18 Addressing these effects through therapies like Expiratory Muscle Training (EMT) can help to improve airflow and ventilation in the lungs, reducing air trapping, mucus clearance, and exercise tolerance12 and overall respiratory function for individuals with obstructive lung diseases. Also, EMT can alleviate some of this fatigue by training the expiratory muscles, thereby reducing the workload on these muscles during exhalation. There are more than 500 studies available on Inspiratory Muscle Training, whereas only less than 40 studies were found on Expiratory muscle training. More emphasis is given
on Inspiratory Muscle Training in COPD patients, whereas, effects of Expiratory muscle training is poorly understood in Indian context. Hence, there is a need to study the effects of expiratory muscle training on expiratory muscle strength, peak cough flow and functional capacity in patients with Obstructive Airway Disease.

AIM:
To assess the effects of 4 weeks of Expiratory muscle training on Peak cough flow, Respiratory muscle strength and Functional capacity in individuals with moderate to severe Chronic Obstructive Airway Disease.

OBJECTIVES:
1. To assess the Peak cough flow, Respiratory muscle strength, and functionalcapacity Pre and Post 4 weeks of conventional physiotherapy (control) group in individuals with Chronic Obstructive Airway Disease.
2. To assess the Peak cough flow, Respiratory muscle strength and functional capacity pre and post 4 weeks of conventional physiotherapy and Expiratory muscle training (Interventional) group in individuals with Chronic Obstructive Airway disease.
3. To compare both the groups.

STUDY PROCEDURE
Patients coming to Chest Medicine OPD and Physiotherapy OPD and diagnosed with Obstructive airway disease by a Pulmonary Physician will be screened and those meeting the Inclusion criteria will be recruited for the study after explaining the study protocol and taking their written consent. The participants will be randomly assigned into Group A i.e. Control group and Group B i.e. Interventional group by simple randomization using Chit Method. 62 chits will be made such that there are 31 chits of each group to ensure equal number in both groups. Each participant will be asked to pick up a chit as they are recruited and will be assigned to the group that is mentioned in the chit. The participants of Group A will be treated on Mondays, Wednesdays and Fridays of the week for 4 weeks while the Group B will be treated on Tuesdays, Thursdays and Saturdays of the week for 4 weeks so that there is no interaction between the groups. The participants demographic data such as age, gender, severity and duration of disease and outcome measures as mentioned previously will be recorded. The endpoint of the study is 4 weeks duration. If the participant becomes breathless during the study, he / she will be immediately discontinued from the study and will be referred to Chest Medicine physician for further management. Participants will be continued their regular Medications as prescribed by Chest Physician during the intervention period.

DATA ANALYSIS
• Peak Cough Flow rate, PImax, PEmax, 6 Min walk distance will be collected pre and post intervention in both groups and will be analysed using SPSS software.
• Descriptive statistics of Mean standard Deviation, median range Confidence Interval etc. determined.
• An paired t-test (parametric data) or Wilcoxon signed rank test (non-parametric data) will be used pre and post for analysis in Conventional physiotherapy group.
• An paired t-test (parametric data) or Wilcoxon signed rank test (non- parametric data) will be used pre and post for analysis in Interventional group.
• Between group analysis will be done using unpaired t test (parametric data) and Mann Whitney U test (non-parametric data).
• Test for significance will be set at 0.05.
• If the intervention group shows significant effect, then effect size using
Cohen’s ‘d’ will be determined.
 
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