| CTRI Number |
CTRI/2025/12/098637 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
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Public Title of Study
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A study comparing effect of Yoga Asanas and Chest Mobilization in patients with Chronic Respiratory Disease. |
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Scientific Title of Study
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Effect of Yoga Asanas versus Chest Mobilization on Pulmonary Function, Functional Capacity, Chest Expansion, and Quality of Life in patients with Chronic Respiratory Disease- A Comparative Study. |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Jain |
| Designation |
MPTh Scholar |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9892847878 |
| Fax |
|
| Email |
nidjain2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nidhi Jain |
| Designation |
MPTh Scholar |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9892847878 |
| Fax |
|
| Email |
nidjain2001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nidhi Jain |
| Designation |
MPTh Scholar |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
Ayurvihar Complex, Eastern Express Hwy, Sion East, Sion, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India |
| Phone |
9892847878 |
| Fax |
|
| Email |
nidjain2001@gmail.com |
|
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Source of Monetary or Material Support
|
| OPD setups of K J Somaiya College of Physiotherapy and Respiratory Medicine Department |
|
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Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nidhi Jain |
K J Somaiya College of Physiotherapy |
CPR OPD no. 12, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai - 400022 Mumbai MAHARASHTRA |
9892847878
nidjain2001@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K J Somaiya College of Physiotherapy |
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: J479||Bronchiectasis, uncomplicated, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (3) ICD-10 Condition: J684||Chronic respiratory conditions dueto chemicals, gases, fumes and vapors, (4) ICD-10 Condition: J459||Other and unspecified asthma, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chest Mobilization |
6 Chest mobilization techniques will be given. 4 of which are chest mobility exercises, 1 muscle stretching and 1 therapist performed chest mobilization. They are-a. Chest Flexion, b. Chest wall extension, c. Lateral flexion of chest wall, d. Chest wall rotation e. Pectoral Muscle Stretching f. Thoracic SNAG extension.
Each mobility exercise will be done 3 times and upto 1 minute hold. Muscle stretching will be done 3 times with upto 1 minute hold. Thoracic SNAG Extension will be performed by therapist 3 times at each thoracic level from T3 to T8. Conventional physiotherapy will be given- breathing exercises and treadmill walking for 15 minutes. Session will begin with a 5 minute warm up and end with 5 minute cool down.
Total 12 sessions in a span of 4 weeks will be conducted. |
| Intervention |
Yoga Asanas |
6 yoga asanas will be given- a. Tadasana, b. Trikonasana, c. Marjarasana, d. Vakrasana, e. Bhujangasana, f. Paschimottasana . Each Asana will be done 3 times with upto 1 minute hold. Conventional physiotherapy will be given- breathing exercises and treadmill walking for 15 minutes. Session will begin with a 5 minute warm up and end with 5 minute cool down.
Total 12 sessions in a span of 4 weeks will be conducted. |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults of all genders aged from 35 to 65 years old who have been diagnosed with Chronic Respiratory Disease having mild to moderate disease (GOLD stage I-II) maintaining SpO2 greater than 85 percent on room air and Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with unstable hemodynamic parameters
Participation in a similar exercise program within the past 6 months
Patients with continuous Oxygen therapy, Patients with artificial ventilation
Acute exacerbation in last 6 weeks ( hospitalization in the last 30 days)
Thoracic surgery within three months
Those who have active lung infection
Grade 4 dyspnoea on MMRC
Physical deformity, psychiatric disease or cognitive disability that can prevent understanding and participation in the study
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test, Six minute walk Test, Chest Expansion, PFSDQ-M questionnaire |
All primary outcomes will be measured once at Baseline and once at 4 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| There are no secondary outcomes |
No outcomes |
|
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Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
18/12/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nidjain2001@gmail.com].
- For how long will this data be available start date provided 30-11-2026 and end date provided 30-11-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
The aim of this study is to compare the effect of yoga asanas and chest mobilization on Pulmonary function, Functional Capacity, Chest Expansion and Quality of Life in patients with Chronic Respiratory Disease. Primary outcomes measured will be- a. pulmonary function through pulmonary function test measuring values of FEV1, FVC, FEV1/FVC. b. functional capacity through six minute walk test measuring six minute walk distance, c. chest expansion through tape measurement at axillary, nipple and xiphisternal level and d. quality of life using pulmonary functional status and dyspnea questionnaire. The total number of participants recruited will be 50 according to sample size calculation. They will be grouped into two groups of 25 by convenience sampling. All participants demographic details will be recorded after they have signed an informed consent form. Group A - yoga asanas and Group B- Chest Mobilization. Each group will undergo 12 sessions of physiotherapy treatment in a span of 4 weeks. The study will take place in Cardiopulmonary Physiotherapy OPD of a tertiary hospital in Mumbai. Primary outcome measures will be measured once before and once after the 12 sessions. Group A -Subjects will perform the following asanas under therapist supervision: a. Tadasana, b. Trikonasana, c. Marjarasana, d. Vakrasana, e. Bhujangasana, f. Paschimottasana All the 6 asanas will be performed 3 times in each session. Each asana will be held for as long as possible (maximum upto 1 minute) by the subject. There will be adequate rest breaks between each asana. Group B-Subjects will perform 4 chest mobility exercises and one stretching exercise under therapist supervision. The subject will also undergo one therapist performed joint mobilization. Chest mobility exercises include: a. Chest Flexion, b. Chest wall extension, c. Lateral flexion of chest wall, d. Chest wall rotation. Muscle stretching exercise is Pectoral Muscle Stretching. Therapist performed Joint Mobilization is Thoracic SNAG extension. All the exercises will be performed 3 times in each session. Each exercise will be held for as long as possible (maximum upto 1 minute) by the subject. There will be adequate rest breaks between each exercise. Both groups will perform 5 minutes warm up, followed by their specific intervention, followed by breathing exercises, 15 minute treadmill walking and end their session with a 5 minute cool down. After completion of data collection data will be statistically analyzed. The results and conclusion will be drawn.
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