| CTRI Number |
CTRI/2024/10/075670 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Bosu Ball and Circuit Training on Quality of Life in Overweight People. |
|
Scientific Title of Study
|
Effect of Bosu Ball with Circuit Training for
Core Strengthening and Quality of Life
Improvement in Overweight
Individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dheeraj Fatnani |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7413037899 |
| Fax |
|
| Email |
dheeraj1997@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Goswami |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Orthopedics Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8058186616 |
| Fax |
|
| Email |
drmeghamunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Goswami |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Orthopedics Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8058186616 |
| Fax |
|
| Email |
drmeghamunshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Instituational Area, Sitapura, Tonk Road, Jaipur, Rajasthan, India, 302022 |
|
|
Primary Sponsor
|
| Name |
Dheeraj Fatnani |
| Address |
C-648 Indra Vihar, Anandpura Phoota Talab, Kota, Rajasthan-302005 |
| 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 Megha Goswami |
Mahatma Gandhi Hospital, Jaipur |
Room No. 14 Physiotherapy OPD, Basement.
Jaipur
RAJASTHAN |
8058186616
drmeghamunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bosu Ball exercises with Circuit training |
Warm-up exercises Jog in place for 2-3 minutes, arm circles both forward and backward, leg swings front to back and side to side, Stretch your calves by standing near a wall and leaning forward with one leg extended behind you and Finish off with some gentle neck rolls and shoulder shrugs to release tension.
Exercises on Bosu ball, Bosu ball one leg bridge, Crunches, Sit ups.
Circuit Training participant moves from one exercise station to the next with limited rest, which results in a short duration of each session. Exercises of Circuit training Jumping jacks, Push ups, Wall sit ,Bicycle crunches, Sumo squats, Mountain climbers, Burpees, Plank.
6 weeks Training Program 5 times a week, A session will take around 45 to 60 minutes on an individual basis.
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
BMI with Overweight Individuals both male & female. i.e. BMI above 25 and above.
Weak core strength [ less than 30 sec hold of McGill core endurance test]
Decreased quality of life [ less than 50 score in SF-36]
Subjects willing to participate in the study.
Subjects able to provide verbal and written consent. |
|
| ExclusionCriteria |
| Details |
Underweight individuals
Recent fractures
Soft tissue injuries
Episodes of mechanical or specific back pain.
Carcinoma
Cardiovascular conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
McGill core endurance test
BMI body mass index
36-Item Short Form Survey (SF-36) |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| McGill core endurance test |
2nd Week, 4th Week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2024 |
| 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="6"
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
|
The eligibility of the participants will be taken on the basis of the inclusion criteria of this researchstudy. The informed consent will be taken from 50 subjects that will be selected according to the inclusion criteria. Pre-Test Procedure: - All the patients who will be involved in the study will be given consent form for their willingness to participate in the study. The demographic data of the patient will be taken on day 1. BMI will be done on the day 1 & the last day of study. The patients will be instructed and taught about the McGill test. The patients will be taught about core strength, bosu ball & circuit training before study i.e. day 1. Treatment Protocol: Warm-up exercises Jog in place for 2-3 minutes to get your heart rate up. Do some arm circles, both forward and backward, to loosen up your shoulder joints. Perform some leg swings, front to back and side to side, to warm up your hip muscles. Stretch your calves by standing near a wall and leaning forward with one leg extended behind you. Finish off with some gentle neck rolls and shoulder shrugs to release tension. These exercises will be performed for 6 weeks, 2 sets of 15 repetitions in the 1st week 3 sets of 15 repetitions in the 2nd week 3 sets of 20 repetitions in the 3rd and 4th weeks 4 sets of 25 repetitions in the 5th and 6th weeks Exercises on Bosu Ball Bosu Ball one leg bridge: ball flat on floor. Lie down on back and place feet on top of the ball. Raise one leg towards the ceiling and push hips up again before touching the floor. Repeat for 10-15 repetitions on each leg. Crunches: lay on bosu ball and bring feet towards the body. Place hands behind head, engage the abs, and slowly raise the upper body (looking upwards). Sit ups: lay over the bosu ball. Raise arms towards the ceiling, engage the abs, and then raise the upper body and towards feet. Hold for a secs and return to starting position. CIRCUIT TRAINING During CT, participant moves from one exercise station to the next, with limited rest, which results in a short duration of each session. The exercises will be performed for 30 secs with 10 secs buffertime and 1 minute rest between the sets. the whole set will be repeated 3 times. Given below are the exercises of Circuit training. Jumping jacks Push ups Wall sit Bicycle crunches Sumo squats Mountain climbers Burpees Plank
|