| 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
|
|
|
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
|
|
|
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. |