| CTRI Number |
CTRI/2024/07/071757 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of Pranayama versus Respiratory Muscle Releasing Technique and Respiratory muscle Coordination/ Facilitation Technique on heart and lung Function in Patients with extended stroke.
|
|
Scientific Title of Study
|
Effects of Pranayama versus Diaphragmatic Releasing Technique and Respiratory Proprioceptive Neuromuscular Facilitation Technique on Cardiorespiratory Function in Patients with Subacute Stroke: A non-randomized Comparative Study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta M Vayal |
| Designation |
Post graduate |
| Affiliation |
MGM school of physiotherapy |
| Address |
MGM Institute of health science
MGM School of Physiotherapy Sector 1, plot no 1 and 2, Neuro-physiotherapy department, OPD no 55 Kamothe, Navi Mumbai, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8779654235 |
| Fax |
|
| Email |
shwetavayal05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Ghosh |
| Designation |
Head of department of neuro physiotherapy |
| Affiliation |
MGM school of physiotherapy, MGM SCHOOL OF PHYSIOTHERAPY, NAVI MUMBAI |
| Address |
MGM Institute of health science
MGM School of Physiotherapy Sector 1, plot no 1 and 2, Neuro-physiotherapy department, physiotherapy school building, OPD no 55, Kamothe, Navi Mumbai, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Ghosh |
| Designation |
Head of department of neuro physiotherapy |
| Affiliation |
MGM school of physiotherapy, MGM SCHOOL OF PHYSIOTHERAPY, NAVI MUMBAI |
| Address |
MGM Institute of health science
MGM School of Physiotherapy Sector 1, plot no 1 and 2, Neuro-physiotherapy department, physiotherapy building, OPD no 55, Kamothe, Navi Mumbai, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
aghosh@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, MGM Institute of Health Sciences
Address- MGM School of Physiotherapy Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy MGM Institute of Health Sciences
Address- MGM School of Physiotherapy Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra, India.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Amrita Ghosh |
MGM institute of health sciences, Navi Mumbai. |
Department of MGM School of Physiotherapy, MGM Institute of health science, OPD room no 55, Sector 1, plot no 1 and 2, Kamothe, Navi Mumbai, Maharashtra 410209.
Raigarh
MAHARASHTRA |
02227437866
aghosh@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE. MAHATMA GANDHI MISSIONS DENTAL COLLEGE AND HOSPITAL |
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: I638||Other cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effects of Pranayama versus Diaphragmatic Releasing Technique and Respiratory Proprioceptive Neuromuscular Facilitation Technique on Cardiorespiratory Function in Patients with Subacute Stroke. |
26 subacute stroke patients that will be recruited of which 13 subacute stroke patients will be practising Diaphragmatic Releasing Technique and Respiratory Proprioceptive Neuromuscular Facilitation Technique for 6 weeks under guidance of the therapist for the project on subacute stroke patients. Pre and post assessment with primary outcome as pulmonary function test and secondary outcome measures as vitals and questionnaire will be used. The data will be studied and compared with interventional group that is Pranayama for better results and effects on cardiorespiratory function in subacute stroke individuals. |
| Intervention |
Effects of Pranayama versus Diaphragmatic Releasing Technique and Respiratory Proprioceptive Neuromuscular Facilitation Technique on Cardiorespiratory Function in Patients with Subacute Stroke. |
26 subacute stroke patients will be recruited for the study, out of which 13 subacute stroke patients will be practising pranayama technique for 6 weeks under guidance of the therapist for the project on subacute stroke patients. Pre and post assessment with primary outcome as pulmonary function test and secondary outcome measures as vitals and questionnaire will be used. The data will be studied and compared with comparator group that is respiratory Diaphragmatic Releasing Technique and Respiratory Proprioceptive Neuromuscular Facilitation Technique for better results and effects on cardiorespiratory function in subacute stroke individuals. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subacute stroke patients with respiratory and cardiovascular muscle weakness
Patients with Ischemic stroke
Both male and female patients
On pre-assessment - patient who will be scoring less on Borg scale for dyspnoea
On pre-assessment - patient who will be scoring less on Fatigue assessment scale
Minimum functional ability
Patient who can perform sitting independently
|
|
| ExclusionCriteria |
| Details |
Known case of other cardiorespiratory complications like COPD and chronic bronchitis
Stroke patients with severe cognition impairment
Patients who are severely hypertensive Patients who are hypertensive even after medications
Patients already practising pranayama and other yogic training
As there will be significant improvement in patients previously practising yoga
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory rate
Heart rate
Blood pressure
Chest expansion
Chest excursion
Pulmonary function test
|
Baseline and six weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Fatigue assessment scale
Borg scale for dyspnoea
Functional independence score.
|
Baseline and six weeks |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
19/08/2024 |
| 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="1"
Months="0"
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
|
The primary focus of this study is to understand the impact of two distinct techniques, namely 6 weeks Pranayama and the Diaphragmatic Release Technique combined with the Respiratory PNF Technique, on individuals with subacute stroke. This research will examine outcome measures such as Respiratory rate, Heart rate, Blood pressure, Chest expansion, Chest excursion, Fatigue assessment scale, Borg scale for dyspnea, Pulmonary function test, and Functional independence score, as both pre and post-intervention evaluation metrics. This study holds significant promise in shedding light on the potential benefits and effectiveness of these techniques in improving the overall respiratory health and functional independence of individuals with subacute stroke |