| CTRI Number |
CTRI/2024/10/075844 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pilates exercise in improving core strength and stability |
|
Scientific Title of Study
|
A Comparative study on role of Pilates exercise in improving core strength and stability among young university adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nageswari Chockalingam |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room no 315, Third floor, School of Allied Health Sciences Department of Physiotherapy, Gautam Buddha Nagar, Sector 17 A yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nageswari@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Basit Mustafa |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room no 315, Third floor, School of Allied Health Sciences Department of Physiotherapy, Gautam Buddha Nagar, sector 17 A, yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
sigimsphysiotherapyproject@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nageswari Chockalingam |
| Designation |
Associate professor |
| Affiliation |
Galgotias University |
| Address |
Room no 315, Third floor, School of Allied Health Sciences Department of Physiotherapy, Gautam Buddha Nagar, sector 17 A, yamuna expressway
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09843073406 |
| Fax |
|
| Email |
nageswari@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
School of Allied Health Sciences Department of Physiotherapy, Gautam Buddha Nagar, sector 17 A, yamuna expressway |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrC Nageswari |
Galgotias university |
Room no 315, third floor, school of Allied Health Sciences Department of Physiotherapy, Sector 17 A yamuna expressway.
Gautam Buddha Nagar
UTTAR PRADESH |
09843073406
nageswari@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal young adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pilates exercises for female |
Group B of Females will be given Pilates exercises for core strengthening and stability for one month three days per week |
| Intervention |
Pilates exercises for males |
Group A of males will be given Pilates exercises for core strengthening and stability for one month three days per week |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Young male and female students of Galgotias University with age group between 17 to 24 years willing to participate in this study.
Physically fit young male and female of correct BMI.
|
|
| ExclusionCriteria |
| Details |
Young Male and Female with any medical issues of Diabetes, or any chronic bone illness, has undergone any recent surgery.
The young male and female who do not fit the BMI
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the strength of core muscles |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the stability of core muscles |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pilates
is a form of exercise that focuses on strengthening the core, improving
stability, and enhancing overall body alignment and flexibility. Developed by
Joseph Pilates in the early 20th century, it emphasizes controlled
movements and proper posture. The core, which includes the muscles of the
abdomen, lower back, and pelvis, is central to Pilates exercises. By engaging
these muscles, Pilates helps to stabilize the spine and improve balance,
coordination, and overall functional strength. Regular practice can lead to
improved posture, reduced risk of injury, and enhanced athletic performance. |