| CTRI Number |
CTRI/2025/07/090106 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
William’s Exercise: A 4-Week Path to Better Flexibility, Core Strength & Spinal Health in Obese Men |
|
Scientific Title of Study
|
Effect of 4 weeks Williams exercise on hamstring flexibility, core endurance and lumbar lordosis in overweight and obese male – 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 |
Patel Zalak Vinodkumar |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
8320964017 |
| Fax |
|
| Email |
zalakpatel627@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Paras Bhura |
| Designation |
Professor |
| Affiliation |
KPGU |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
7861805174 |
| Fax |
|
| Email |
parasbhura.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Patel Zalak Vinodkumar |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
Ward 4/A, plot no. 61, house no.9, kanku society, Adipur, Kutch
Vadodara
GUJARAT
370205
India |
| Phone |
8320964017 |
| Fax |
|
| Email |
zalakpatel627@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OPD, Matrushri Davalba Hospital |
|
|
Primary Sponsor
|
| Name |
Patel Zalak Vinodkumar |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University, Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India |
| 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 Patel Zalak Vinodkumar PT |
Physiotherapy OPD, Matrushri Davalba Hospital |
KPGU, Vadodara - Mumbai, National Highway 8, Varanama, Vadodara, Gujarat.
KPGU, Vadodara - Mumbai, National Highway 8, Varanama, Vadodara, Gujarat.
Vadodara
GUJARAT |
8320964017
zalakpatel627@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research, KPGU. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and obese |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Williams Exercise |
Pre- as well as post-outcome measures sit and reach test, McGill endurance test and flexible ruler measure will be taken to determine the effect of intervention william’s exercise. Duration for intervention will be 4 days a week for period of 4 weeks. The total 16 session will be given. Protocol will be started with 1 set of 10 repetitions at starting and if the performance improves and patient’s compatibility with trainings, eventually finished with 3 sets of 20 repetitions at the end of protocols. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Male
Age 18 to 35yrs
BMI more than 24.9
Willingness
|
|
| ExclusionCriteria |
| Details |
Any major musculoskeletal injury since last 6 months like strain, sprain, subluxation and dislocation.
Known case of any neurological, cardiac, respiratory disease.
Any other medical, surgical or psychological case.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hamstring Flexibility
Core Endurance
Lumbar Lordosis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
21/07/2025 |
| 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="5"
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
|
Obesity is growing global concern over 135 million in India are affected. Above BMI 25kg/m2 increases the health risk, among these lumbar lordosis is common out of other musculoskeletal impairment affecting endurance and muscle strength. William exercise designed to strengthen postural muscle targeting abdominal muscles. This study is an Experimental design, involve 35 overweight band obese male age group of 18 to 35 years with 16 session so AIM of study is to check the effect of 4 weeks William’s exercise on hamstring flexibility, core endurance and lumbar lordosis in overweight and obese males. |