| CTRI Number |
CTRI/2024/05/067021 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [YOGIC BREATHING EXERCISES] |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of the effect of simple yogic breathing exercises on pain, stress and quality of life among old age population |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE EFFECTIVENESS OF SIMPLE YOGIC BREATHING EXERCISES ON PAIN, STRESS AND QUALITY OF LIFE OLD AGE POPULATION - AN EXPERIMENTAL 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 |
VINAL CHARPOT |
| Designation |
LECTURER IN PHYSIOTHERAPY |
| Affiliation |
Government Physiotherapy College |
| Address |
Government Physiotherapy college and Government spine Institute, opposite Cancer Hospital, Civil Hospital, Ahmedabad -380016
Ahmedabad- 380016
AHMEDABAD
Ahmadabad
GUJARAT
380060
India |
| Phone |
9099300339 |
| Fax |
|
| Email |
vinalcharpot3374@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUKESH VORA |
| Designation |
HOD OF PHARMACOLOGY DEPARTMENT |
| Affiliation |
GMERS MEDICAL COLLEGE ,SOLA CIVIL HOSPITAL |
| Address |
HOD,
DEPARTMENT OF PHARMACOLOGY
GMERS MEDICAL COLLEGE, SOLA
CIVIL HOSPITAL
AHMEDABAD-380060
AHMEDABAD
ETHICAL COMMITTEE DEPARTMENT
GMERS MEDICAL COLLEGE ,SOLA
CIVIL HOSPITAL
AHMEDABAD-380060
Ahmadabad
GUJARAT
380060
India |
| Phone |
9228117957 |
| Fax |
|
| Email |
mukeshkrutin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VINAL CHARPOT |
| Designation |
LECTURER IN PHYSIOTHERAPY |
| Affiliation |
Government physiotherapy college |
| Address |
Government Physiotherapy College and Government Spine Institute,
Staff room- second floor
Civil Hospital, Asarwa
AHMEDABAD-380016
Ahmadabad
GUJARAT
380060
India |
| Phone |
9099300339 |
| Fax |
|
| Email |
vinalcharpot3374@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT PHYSIOTHERAPY COLLEGE
GOVERNMENT SPINE INSTITUTE ,CIVIL HOSPITAL,AHMEDABAD. |
|
|
Primary Sponsor
|
| Name |
VINAL CHARPOT |
| Address |
GOVERNMENT PHYSIOTHERAPY COLLEGE
GOVERNMENT SPINE INSTITUTE
CIVIL HOSPITAL, AHMEDABAD |
| 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 |
| DR VINAL CHARPOT |
GOVERNMENT PHYSIOTHERAPY COLLEGE |
PHYSIOTHERAPY DEPARTMENT
STAFF ROOM NUMBER -109
FIRST FLOOR
CIVIL HOSPITAL
AHMEDABAD-380016
Ahmadabad
GUJARAT |
09099300339
vinalcharpot3374@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical committee,GMERS Medical college and Civil Hospital ,Sola, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All Non - Pathological Musculoskeletal kinds of pain complain of osteoarthritis b/l knee pain, shoulder pain, low back pain, neck pain, leg pain , back pain,hand pain, hip pain |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IN CONTROL GROUP- NO INTERVENTION
IN EXPERIMENTAL GROUP - FOUR TYPES OF YOGIC BREATHING EXERCISE WILL BE GIVEN |
1)SLOW DEEP BREATHING X 10 REPETITIONS
2)ANULOM VILOM X 10 REPETITIONS
3)BHRAMRI GUNJAN X10 REPETITIONS
4)OM CHANTING X 10 REPETITIONS
IN ONE SESSION
TOTAL 40 REPETITIONS
DURATION -20 MINUTES
SUCH SESSION SIX DAYS/WEEK
CONTINUE FOR 6 WEEKS
|
| Comparator Agent |
TO SEE EFFECT OF SIMPLE BREATHING EXERCISES ON PAIN AND STRESS IN OLD PEOPLE |
YOGIC BREATHING EXERCISES SUCH AS SLOW DEEP BREATHING, ANULOM VILOM, BHARAMRI GUNJAN ,OM CHANTING |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
AGE ABOVE 60 YEARS
MALE AND FEMALE BOTH WILL BE INCLUDED
WHO WILL WILLING TO PARTICIPATE IN THIS STUDY
|
|
| ExclusionCriteria |
| Details |
ALL PATHOLOGICAL CONDITIONS INCLUDING
NEURO- MUSCULAR DISORDERS,
CARDIOVASCULAR ABNORMALITIES,
MENTAL ILLNESS,
NON COOPERATIVE ,
METABOLIC DISORDERS,
T.B, MAJOR ABDOMINAL SURGERIES,
RECENT FRACTURES,SKIN DISEASES,
YOGA PRACTITIONER |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NUMERICAL PAIN RATING SCALE
PERCEIVED STRESS SCALE
WHOQOL-BREF FOR QUALITY OF LIFE
PERCEIVED S
QUALITY OF LIFE -WHOQOL BREF
|
6 WEEKS
QUALITY OF LIFE -WHOQOL BREF
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OVER ALL QUALITY OF LIFE BY WHOQOL-BREF |
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
30/05/2024 |
| 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="0"
Months="1"
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
|
This interventional study aims to assess the effectiveness of yogic breathing, particularly on pain and stress. The method is simple to understand, low-cost, and affordable, making it accessible to anyone, anywhere, and at any time. The study will use simple yogic breathing exercises, giving intervention for a 6-week protocol to observe the improvement in the quality of life of old age individuals who are suffering from stress and pain. |