| CTRI Number |
CTRI/2024/09/074417 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy and Yoga] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of aerobic exercise. yoga and meditation on physical fitness in physiotherapy students: Experimental Study |
|
Scientific Title of Study
|
Effectiveness of ‘Whole-Fit Program’ on Physical Activity Levels, Physical Fitness Index & Mental Health among Physiotherapy Students of Ratnagiri Rural Area: A Quasi 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 |
ASMA SHARMA |
| Designation |
Associate Professor |
| Affiliation |
BKL Walawalkar Medical college hospital |
| Address |
204, Seena building BKL Walawalkar hospital post sawarde Taluk Chiplun, district Ratnagiri
BKL College of Physiotherapy, Post sawarde Taluk Chplun District Ratnagiri
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
8006246478 |
| Fax |
|
| Email |
aasma.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASMA SHARMA |
| Designation |
Associate Professor |
| Affiliation |
BKL Walawalkar Medical college hospital |
| Address |
204, Seena building BKL Walawalkar hospital post sawarde Taluk Chiplun, district Ratnagiri
BKL College of Physiotherapy, Post sawarde Taluk Chplun District Ratnagiri
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
8006246478 |
| Fax |
|
| Email |
aasma.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASMA SHARMA |
| Designation |
Associate Professor |
| Affiliation |
BKL Walawalkar Medical college hospital |
| Address |
204, Seena building BKL Walawalkar hospital post sawarde Taluk Chiplun, district Ratnagiri
BKL College of Physiotherapy, Post sawarde Taluk Chplun District Ratnagiri
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
8006246478 |
| Fax |
|
| Email |
aasma.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| BKL Walawalkar College of Physiotherapy Post sawarde Taluk Chiplun District Ratnagiri Pin 415606 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Private medical college |
|
|
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 Asma Sharma |
BKL Walawakar Hospital , OPD building |
CVRS & Fitness OPD Room No 21, OPD Building, BKL Walawalkar Hospital post sawarde Taluk Chiplun
Ratnagiri
MAHARASHTRA |
8006246478
aasma.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BKL Walawalkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physical fitness and mental health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Whole Fit Program |
Supervised ‘Whole-fit Program’ which consists of following:
Day 1: 30 min Strengthening (UL&LL) 30 min + 10 min guided meditation
Day 3: Aerobic exercises Low to moderate intensity 30 min + 10 min guided meditation
Day 5: Yoga (10 Surya Namaskar) + 10 min guided meditation
Intervention will be given for 3 months; 3days/week 1 hour daily with 5 min of each warm up & cool down Ex’s including gentle stretching & joints ROM Ex’s
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy young males and females college students
|
|
| ExclusionCriteria |
| Details |
Who have physical Mental or Musculoskeletal disabilities
Those having Asthma Diabetes Hypertension
Students with locomotor disorders
History of Drug intake Alcohol and smoking
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Step Test Pulse Count at end of 3.5 minute after Modified Harvard Step test in Males less than 84 in Females less than 93 |
Step Test Pulse Count at end of 3.5 minute after Modified Harvard Step test in Males less than 84 in Females less than 93-after 3 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Happiness Index by using Oxford’s 5 point Likert scale questionnaire score 4 and above
|
Happiness Index by using Oxford’s 5 point Likert scale questionnaire score 4 and above after 3 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
04/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Phase 1 of this study is to examine
the existing patterns of physical activity levels, physical fitness levels,
mental well being in young adults of physiotherapy course attending
college by using appropriate test fitting anthropometric variations among
Indian population.
Findings of low grades among students in
any of the parameter, an exercise program to improve physical & mental well
being as a whole will be implemented in second phase of the study.
Also it is the need of the hour to
inculcate the physical activity hours in academic curriculum to maintain the
physical & mental well being of students. |