| CTRI Number |
CTRI/2020/12/029994 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
22/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study to see effect of the addition of yoga exercises in management of pelvic injury patients. |
|
Scientific Title of Study
|
Impact of yoga intervention on functional assessment and quality of life in pelvic injury patients at level-I trauma Center – A Randomized Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Bagaria |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
130, JPNATC, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9914201918 |
| Fax |
|
| Email |
dr_bagaria@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Bagaria |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
130, JPNATC, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
9914201918 |
| Fax |
|
| Email |
dr_bagaria@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Bagaria |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
130, JPNATC, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
9914201918 |
| Fax |
|
| Email |
dr_bagaria@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Research Grant from Ministry of Science and Technology, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology Government of India |
| Address |
Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,,
New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Dinesh Bagaria |
AIIMS,New Delhi |
130, JPN Apex Trauma Center, Division of trauma surgery
South
DELHI |
9914201918
dr_bagaria@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S32||Fracture of lumbar spine and pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
conventional physiotherapy by physiotherapist |
| Intervention |
Yoga along with conventional physiotherapy |
Yoga sessions by trained yoga instructor along with conventional physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Admitted patients
Patients with pelvic injuries planned non-operative management
|
|
| ExclusionCriteria |
| Details |
Neuro trauma patients with restricting mobility and/ or with decreased mental status.
Patients undergoing any surgery for any other injury
Patient with malignancies, coagulation and bleeding disorders
Pre-existing disability/ comorbidity which may interfere with yoga therapy.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Functional assessment of pelvic injury patients.
2.Quality of life of the pelvic injury patients
3.Immune functional assessment by measuring immature cd35- to mature cd 35 + granulocytes ratio in peripheral blood.
|
up to 12 weeks
|
|
|
Secondary Outcome
|
|
|
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)
|
01/01/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pelvic trauma due to road traffic accidents leads to morbidity & poor quality of life. Pelvic ring constitutes a major part of pelvic and body stability and each additional bone fracture is associated with an increased likelihood of developing complications. Each additional bony element fracture increases the pain and developing infectious complications. Moreover, reduced mobility in pelvic trauma increases the likelihood of venous thrombosis. Benefits of yoga have been documented in many studies in patients of Asthma, Parkinsonism, multiple sclerosis, etc. but there is no literature available for the benefit of yoga in pelvic trauma patients. So, this study is intended to see the beneficial effects of Yoga in pelvic trauma patients in terms of immunity biomarkers, functional assessment, and quality of life. |