| CTRI Number |
CTRI/2023/01/048897 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Pranayama on movement of chest wall, respiratory muscle and lung function in patients with lung disease |
|
Scientific Title of Study
|
Influence of Pranayama breathing techniques on thoracic cage biomechanics, respiratory muscle activity and lung function in patients with chronic respiratory disease: A randomized controlled trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dishti Solanki |
| Designation |
MPT student |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9833693421 |
| Fax |
|
| Email |
dsolanki@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Bela Agarwal |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)
Raigarh
MAHARASHTRA
410209
India |
| Phone |
981900064 |
| Fax |
|
| Email |
bagarwal@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bela Agarwal |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)
MAHARASHTRA
410209
India |
| Phone |
981900064 |
| Fax |
|
| Email |
bagarwal@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector-1, Kamothe, Navi Mumbai |
|
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Primary Sponsor
|
| Name |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School Of Physiotherapy Institute of Health Sciences, Sector-1, Kamothe, Navi Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajani Mullerpatan |
MGM Centre of Human Movement Science, MGM School of Physiotherapy, MGM Institute of Health Sciences |
1st floor, MGM Super specialty Hospital, Plot No. 46, Sector No. 30, Vashi, Navi Mumbai
Raigarh
MAHARASHTRA |
9920048476
rajani.kanade@gmail.com |
| Dr Rajani Mullerpatan |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
OPD No. 55, Physiotherapy Department, 2nd floor
Raigarh
MAHARASHTRA |
9920048476
rajani.kanade@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J40||Bronchitis, not specified as acuteor chronic, (2) ICD-10 Condition: J418||Mixed simple and mucopurulent chronic bronchitis, (3) ICD-10 Condition: J42||Unspecified chronic bronchitis, (4) ICD-10 Condition: J430||Unilateral pulmonary emphysema [MacLeods syndrome], (5) ICD-10 Condition: J431||Panlobular emphysema, (6) ICD-10 Condition: J432||Centrilobular emphysema, (7) ICD-10 Condition: J438||Other emphysema, (8) ICD-10 Condition: J439||Emphysema, unspecified, (9) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, (10) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (11) ICD-10 Condition: J452||Mild intermittent asthma, (12) ICD-10 Condition: J453||Mild persistent asthma, (13) ICD-10 Condition: J454||Moderate persistent asthma, (14) ICD-10 Condition: J455||Severe persistent asthma, (15) ICD-10 Condition: J455||Severe persistent asthma, (16) ICD-10 Condition: J459||Other and unspecified asthma, (17) ICD-10 Condition: J470||Bronchiectasis with acute lower respiratory infection, (18) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, (19) ICD-10 Condition: J60||Coalworkers pneumoconiosis, (20) ICD-10 Condition: J61||Pneumoconiosis due to asbestos andother mineral fibers, (21) ICD-10 Condition: J620||Pneumoconiosis due to talc dust, (22) ICD-10 Condition: J628||Pneumoconiosis due to other dust containing silica, (23) ICD-10 Condition: J630||Aluminosis (of lung), (24) ICD-10 Condition: J631||Bauxite fibrosis (of lung), (25) ICD-10 Condition: J632||Berylliosis, (26) ICD-10 Condition: J633||Graphite fibrosis (of lung), (27) ICD-10 Condition: J634||Siderosis, (28) ICD-10 Condition: J635||Stannosis, (29) ICD-10 Condition: J636||Pneumoconiosis due to other specified inorganic dusts, (30) ICD-10 Condition: J64||Unspecified pneumoconiosis, (31) ICD-10 Condition: J65||Pneumoconiosis associated with tuberculosis, (32) ICD-10 Condition: J660||Byssinosis, (33) ICD-10 Condition: J670||Farmers lung, (34) ICD-10 Condition: J80||Acute respiratory distress syndrome, (35) ICD-10 Condition: J811||Chronic pulmonary edema, (36) ICD-10 Condition: J82||Pulmonary eosinophilia, not elsewhere classified, (37) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, (38) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
pulmonary rehabilitation with a 5 days/week program with 2 supervised sessions for 12 weeks with a total of 20- 30 minutes each session, including aerobic and/ or resistance type of training at 60-70% of their Heart Rate Reserve (HRR). The number of repetitions will be increased to provide a gradual progression and increase the intensity of training |
| Intervention |
Experimental Group |
A 5 days/week program with 2 supervised sessions for 12 weeks and each session for 20-30 minutes. It includes Pranayam intervention with one set of Anulom Vilom, Bhramari, Kapalbhatti, and Omkar performed in the same order and pulmonary rehabilitation includes aerobic and/ or resistance type of training at 60-70% of their Heart Rate Reserve (HRR). The number of repetitions will be increased to provide a gradual progression and increase the intensity of training |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
i. Any stable chronic respiratory diseases over 4 weeks (ICD 10 Classification- Bronchitis (J40-42), Emphysema (J43), other COPD (J44), Asthma (J45-46), Bronchiectasis (J47), Pneumoconiosis (J60-70), Adult respiratory distress syndrome (J80), Idiopathic Pulmonary Fibrosis (J84)
ii. Age group of 18- 75 years both male and female
iii. Mild to severe obstructions with GOLD grade 1-3, post bronchodilator FEV1/FVC <0.7, FEV1 30- 80% for obstructive conditions and FVC<80% with FEV1/FVC >0.7 for restrictive conditions
|
|
| ExclusionCriteria |
| Details |
i. Recent exacerbation of the disease
ii. Associated cardiac, psychological, neurological disorders
iii. BMI >35 kg/m2
iv. Thoracic cage abnormalities like scoliosis, kyphosis, recent trauma, fractures of ribs
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Kinematics of the thorax using 3D motion-capture system
• Pulmonary lung functions will measure the forced vital capacity, forced expiratory volume, at 1 second maximum inspiratory pressure, maximum expiratory
• Respiratory muscle activity assessment using surface EMG
• Assess the cardiovascular endurance using six-minute walk test
|
Pre intervention, at the 6th week of intervention, at the 12th week of intervention
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
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Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
16/01/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The objective of the study is to evaluate the influence of Pranayama breathing techniques on thoracic cage biomechanics, respiratory muscle activity, and lung function in patients with chronic respiratory disease. It is a randomized controlled trial where two groups of patients with chronic respiratory disease will be undergoing rehabilitation for a period of 12 weeks. The control group will be receiving conventional pulmonary rehabilitation and the experimental group will receive additional Pranayam breathing techniques. The patients will be assessed for thoracic kinematic using reflective markers and the motion of the chest will be evaluated by the Vicon 3D motion capture system, respiratory muscle activity will be assessed by surface EMG, and pulmonary lung functions will measure the forced vital capacity, forced expiratory volume, at 1-second maximum inspiratory pressure, maximum expiratory and cardiovascular endurance will be recorded by six-minute walk test. The patient will be assessed at the beginning and end of the 12-week intervention. Knowledge gained from the study will help the prescription of evidence-based pulmonary rehabilitation including Pranayama to improve chest mobility, respiratory muscle activity, and lung function. |