| CTRI Number |
CTRI/2024/07/070956 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| 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
|
Comparing the Effects of Mat Pilates and Calisthenics on Abdominal Obesity in Young
Adults A Randomized Clinical Trial |
|
Scientific Title of Study
|
Therapeutic Effectiveness Of Mat Pilates Versus Calisthenics In Young Adults With Abdominal Obesity using Anthropometric Parameters-A Randomized Clinical Trial
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutwika Kale |
| Designation |
Student |
| Affiliation |
Kle institute of physiotherapy belgavi |
| Address |
Kle college of physiotherapy, orthopaedic department of physiotherapy, nehru nagar belgavi-590010, Karnataka
Kle college of physiotherapy, nehru nagar belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7387914660 |
| Fax |
|
| Email |
rutwikakale7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aarti welling |
| Designation |
Assistant professor |
| Affiliation |
Kle institute of physiotherapy |
| Address |
Kle college of physiotherapy, orthopaedic department of physiotherapy, nehru nagar belgavi-590010, Karnataka
Kle college of physiotherapy, neru nagar belgavi karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwelling@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rutwika |
| Designation |
Student |
| Affiliation |
Kaher institute of physiotherapy |
| Address |
Kle college of physiotherapy, orthopaedic department of physiotherapy, nehru nagar belgavi-590010, Karnataka
Kle college of physiotherapy, neru nagar belgavi karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7387914660 |
| Fax |
|
| Email |
rutwikakale7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kle institute of physiotherapy neru nagar belgavi karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Rutwika Kale |
| Address |
Kle institute of physiotherapy nehru nagar belgavi 590010 karanataka |
| 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 aarthi welling |
Kle institute of physiotherapy |
Kle institute of physiotherapy orthopaedic department nehru nagar belgavi karnataka
Belgaum
KARNATAKA |
9448814569
aartiwelling@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee kle institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Therapeutic Effectiveness Of Mat Pilates Versus Calisthenics In Young Adults With Abdominal Obesity using Anthropometric Parameters-A Randomized Clinical Trial |
5week intervention 3sessison in a week with warm up and cool down exercises |
| Comparator Agent |
Therapeutic Effectiveness Of Mat Pilates Versus Calisthenics In Young Adults With Abdominal Obesity using Anthropometric Parameters-A Randomized Clinical Trial |
5week intervention 3sessison per week and warm up exercises and cool down exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Between age group 18-30
Pre obese and post obese
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Diagnosed with diabetes mellitus
History of any surgery 6 months
Any psychology issue
With recent fracture |
|
|
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 |
Body mass index
Body impedance analyser
Waist hip ratio |
Baseline and one month after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscular endurance curl up test |
Baseline and one month after intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
29/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 now days most serious public health problem especially in young adults also obesity and overweight are associated with genetic and environmental factors1 The global prevalence of overweight and obesity is steadily rising, impacting individuals of all age groups, genders, and ethnicities.2 Pilates devised a comprehensive approach to enhance muscle strength and flexibility under the premise of mind-body control, intending to cultivate a robust physique.3 Pilates works well for improving flexibility, activating the deep core muscle transversus abdominis, stabilizing the pelvic-lumbar region, and increasing overall muscle activity in healthy adults 3 |