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CTRI Number  CTRI/2021/10/037305 [Registered on: 13/10/2021] Trial Registered Prospectively
Last Modified On: 22/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Video Assisted Versus Traditional method of training breathing exercise on single breath count and chest expansion in patients with respiratory Diseases. 
Scientific Title of Study   Effect of Video Assisted Versus Traditional method of training diaphragmatic breathing exercise on single breath count and chest expansion in patients with Pulmonary Disease: A Comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariya P Jiandani 
Designation  Associate professor 
Affiliation  P.T. School and centre, seth G.S.Medical college and KEM hospital 
Address  PT school and centre, seth GSMC and KEMH,KEH hospital,acharya donde marg, parel(E),mumbai-12

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mariya P Jiandani 
Designation  Associate professor 
Affiliation  P.T. School and centre, seth G.S.Medical college and KEM hospital 
Address  PT school and centre, seth GSMC and KEMH,KEH hospital,acharya donde marg, parel(E),mumbai-12

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chinmay A Dode 
Designation  Post-graduate student MPT 
Affiliation  P.T. School and centre, seth G.S.Medical college and KEM hospital 
Address  PT school and centre, seth GSMC and KEMH,KEH hospital,acharya donde marg, parel(E),mumbai-12

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  drchinmaydode@gmail.com  
 
Source of Monetary or Material Support  
PT school and centre , Seth GSMC and KEM Hospital, Parel(E), Mumbai-12 
 
Primary Sponsor  
Name  Mariya P Jiandani 
Address  PT school and centre, Seth GSMC and KEMH,Parel(E),Mumbai-12 
Type of Sponsor  Other [[self]] 
 
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 
Mariya P Jiandani  PT school and centre, Seth GSMC and KEM Hospital  OPD number 16,cardiovascular and thoracic centre,KEM hospital,mumbai
Mumbai (Suburban)
MAHARASHTRA 
02224143435

mpjiandani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics comittee of seth G S Medical college and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Traditional diaphragmatic breathing exercise  in traditional diaphragmatic breathing exercise, breathing exercise will be taught to the patients in face to face manner which contains proprioceptive feedback by the therapist and patients will be asked to perform breathing exercise regularly at home. group will be provided with the chart of breathing exercise so that participants can use chart as a feedback during self-practice. 
Intervention  Video assisted diaphragmatic breathing exercise  Video contains animation showing movement of air withing airways and lungs, movement of diaphragm, inbuilt auditory instructions, these all are in synchrony. Video has Inbuilt instructions in 3 languages (English, Marathi, Hindi) with self-generated audio input and instructions are also displayed in 3 languages (English, Marathi, Hindi) on the screen itself in writing so that patient can read by himself. group receiving video assisted treatment method will be provided with the video for self practice at home.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient age between 18-60 of either sex. Medically diagnosed with primary pulmonary disease referred to physiotherapy for breathing exercises. Those visiting for first time to cardio-respiratory rehabilitation centre. Patients having phone which has facility to watch the video. 
 
ExclusionCriteria 
Details  1) Patients with primary cardiac disease.
2) Patients with known vision abnormality and auditory dysfunction.
3) Patients in acute exacerbations, febrile, who are haemodynamically unstable,
with high respiratory rates >28.
4) Patients with primary Neurological conditions such as Guillain-Barre
syndrome, stroke, Parkinson’s disease etc.
5) Patients with primary muscular disease such as muscular dystrophy,
polymyositis, fibromyalgia etc.
6) Patients not willing to participate in the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Single breath count (SBC)  Baseline, 2 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
chest expansion  baseline, 2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2021 
Date of Study Completion (India) 01/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Breathing exercise forms an essential part of rehabilitation of patients with primary pulmonary disease. Most patients with pulmonary dysfunctions have altered breathing pattern with use of accessory muscles. They need correct training of recruitment of respiratory muscles, primarily diaphragm. A correct technique of doing Breathing exercise improves ventilation and pulmonary function. Traditionally breathing training program is given to the patients by face to face method with regular follow-ups or visits after 2 weeks.
With evolution of era and technology, we all are familiar with screen devices like smartphones and all others. The pandemic has brought in online consultations and tele-rehabilitation. Use of tele-rehabilitation requires constant online time, connectivity and manpower. Use of pre-recorded video in training would be flexible and not need connectivity or manpower. It is essential to see the effectiveness of using such technology in treatment purpose when compared with traditional method. As this Diaphragmatic breathing exercise is the preliminary breathing exercise, this study aimed to compare the effect of video assisted versus traditional method of training diaphragmatic breathing exercise on single breath count and chest expansion in patients with Pulmonary Disease.
Effect on Pulmonary function variables such as single breath count (SBC), Chest expansion(upper chest expansion at T5 and Lower chest expansion at T10) were measured and data was compared among video assisted training and traditional breathing training. Patients having diagnosis of primary pulmonary disease, age between 18-60, having screen device which has facility to watch video and those who were referred to physiotherapy for breathing exercise for 1st time were included. Pre-treatment parameters such as single breath count and chest expansion(upper chest & lower chest) were taken. Then among these patients, individuals were selected randomly using blinded envelop method to whom either traditional breathing retraining was taught or video assisted breathing was taught. Patients were advised to practice taught technique at home 3 times a day regularly for 2 weeks period and further during their routine follow up after 2 weeks, re-assessment was done using SBC, chest expansion(upper chest & lower chest). Objective data was collected for both these methods, both traditional and video assisted group generated statistically significant results on SBC and chest expansion (p<0.0001). There was no difference between two methods of training on SBC(p=0.2428), upper chest expansion(0.6995) and lower chest expansion(p=0.1810). in this trial, it is concluded that both methods were found to be equally beneficial in improving pulmonary functions in patients with pulmonary disease after 2 weeks of training.  
 
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