| CTRI Number |
CTRI/2024/03/064350 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Physiotherapy and Yoga Exercises in Back pain in Women Athletes |
|
Scientific Title of Study
|
Effectiveness of Physio-Yogic Exercises in Lumbo-Pelvic Pain in Women Athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Shalini |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University |
| Address |
Rooom No-11, Lower Ground Floor, F-1 Block, Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8800249863 |
| Fax |
|
| Email |
priyashalini297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University |
| Address |
Room No-23, Lower Ground Floor F-1 Block, Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
96544781 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rabab Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Health Allied Sciences, Amity University |
| Address |
Room No-23, Lower Ground Floor, F-1 Block, Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh, Sector 125, Noida, Uttar Pradesh
UTTAR PRADESH
201301
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Vyasa Polyclinic & Physiotherapy Rehabilitation Centre, C-72, Vikas puri, New Delhi, 110018 |
|
|
Primary Sponsor
|
| Name |
Priya Shalini |
| Address |
F-1 Block, Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh, Sector 125, Noida, Uttar Pradesh |
| 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 Priya Shalini |
Vyasa Polyclinic & Physiotherapy Rehabilitation Centre |
Room number 2, Physiotherapy department, C-72, Shaheed Rajguru Marg, opp. Reliance Mall, Block C, Vikaspuri, New Delhi, Delhi, 110018
West
DELHI |
8800249863
priyashalini297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh |
Approved |
| Vyasa Polyclinic & Physiotherapy Rehabilitation Centre |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S399||Unspecified injury of abdomen, lower back, pelvis and external genitals, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Athlete Life Quality Scale questionnaire |
Data will be collected before and after the rehabilitation period.
After a rehabilitation period of 4 weeks the athletes will be asked to fill the questionnaires again and the scores will be calculated analysed and the results, compared.
Data will be collected at baseline and after 4 weeks
|
| Comparator Agent |
LEFS (Lower extremity functional scale) |
Data will be collected before and after the rehabilitation period.
After a rehabilitation period of 4 weeks the athletes will be asked to fill the questionnaires again and the scores will be calculated analysed and the results, compared.
Data will be collected at baseline and after 4 weeks. |
| Comparator Agent |
Numeric Pain Rating Scale |
Data will be collected before and after the rehabilitation period.
After a rehabilitation period of 4 weeks the athletes will be asked to fill the questionnaires again and the scores will be calculated analysed and the results, compared.
Data will be collected at baseline and after 4 weeks.
|
| Intervention |
Physiotherapy and yoga exercises. |
A sample size of 45 athletes will be taken and will be divided into 3 groups containing 15 athletes each.
Group A will receive specific Lumbar exercises for rehabilitation.
Group B will receive combination of Lumbar exercises and Yoga exercises for rehabilitation.
Group C will receive Yoga Exercises for rehabilitation
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 20-28 years
2. Recreational female marathon runners.
3. Diagnosed case of lumbo pelvic pain.
4. Participants willing to participate.
|
|
| ExclusionCriteria |
| Details |
1. Any traumatic injury.
2. Any surgical history.
3. Diagnosed case of fracture.
4. Any congenital musculoskeletal and neurological disorders.
5. Received steroid injection in past 12 months.
6. Already enrolled in a physiotherapy program |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Athlete Life Quality Scale questionnaire |
Baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LEFS (Lower extremity functional scale) |
Baseline and after 4 weeks |
| Numeric Pain Rating Scale (NPRS) |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| 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="3"
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
|
Yoga is an Indian discipline and way of life
that consists of physical postures, breathing exercises that are done
voluntarily, meditation, some philosophical ideas, and advice on how-to live-in
harmony with the natural laws of the universe. |