| CTRI Number |
CTRI/2022/05/042425 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
30/04/2022 |
| 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
|
To see the effectiveness of exercise protocols on various health factors in patients who have undergone bariatric(weight loss) surgery. |
|
Scientific Title of Study
|
Effectiveness of Aerobic and Resisted exercise training in post-bariatric subjects on aerobic capacity, body composition, physiological and psychological parameters: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kinjal Trivedi |
| Designation |
Consultant Physiotherapist |
| Affiliation |
Parul university |
| Address |
Room no.312, Physiotherapy Department, Beside temple, Parul Institute of Physiotherapy, Parul University,Post Limda, Waghodia, Gujarat
C-502, Rajeshree Arcade, Jodhpur cross road jodhpur gam road, Satellite, Ahmedabad 380015
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980286412 |
| Fax |
|
| Email |
kinjaltrivedi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kinjal Trivedi |
| Designation |
Consultant Physiotherapist |
| Affiliation |
Parul university |
| Address |
Room no.312, Physiotherapy Department, Beside temple, Parul Institute of Physiotherapy, Parul University,Post Limda, Waghodia, Gujarat
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980286412 |
| Fax |
|
| Email |
kinjaltrivedi21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kinjal Trivedi |
| Designation |
Consultant Physiotherapist |
| Affiliation |
Parul university |
| Address |
Room no.312, Physiotherapy Department, Beside temple, Parul Institute of Physiotherapy, Parul University,Post Limda, Waghodia, Gujarat
Ahmadabad
GUJARAT
391760
India |
| Phone |
8980286412 |
| Fax |
|
| Email |
kinjaltrivedi21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hope Obesity center, Abhinandan Complex, 1st floor, Opp. TRP mall, Bopal, Ahmedabad |
| Parul University, Limda, Waghodia, Vadodara, Gujarat
|
|
|
Primary Sponsor
|
| Name |
Dr Kinjal Trivedi |
| Address |
C-502 Rajeshree Arcade,Opp.Anupam shopping center, Jodhpur cross road-Jodhpur gam road, Satellite, Ahmedabad. |
| 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 |
| DrDigvijay Singh Bedi |
Hope Obesity |
Abhinandan complex, Wing A, 2nd floor, opp. TRP mall, Bopal, Ahmedabad.
Ahmadabad
GUJARAT |
9824012582
bopalhospital04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini hospital ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercises, Resisted exercise |
Aerobic exercise 3days/week, Resisted exercise 2days/week. |
| Comparator Agent |
No treatment |
No treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)BMI more than 30
2)Medically stable, undergoing bariatric surgery |
|
| ExclusionCriteria |
| Details |
1)Moderate to severe illness of any system
2)High risk patient for cardiovascular and neurological system
3)Musculoskeletal pathology
4)Inability to perform the functional tests and interventions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VO2R, Waist Circumference, 1RM, BMI, Blood Pressure, HbA1C, Becks Depression Inventory, Gastro-intestinal Symptom Rating Scale. |
Every 4weeks Interval till subjects show deconditioning effect. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Six-minute walk distance
2)Skinfold thickness
3)Body weight
4)Heart Rate Recovery
5)Rate Pressure Product
6)Rate of perceived Exertion |
4weeks, 8weeks, till deconditioning is noted. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is a disease characterized by excess adiposity that is a source of extensive morbidity and mortality due to various weight related complications. It results from low physical activity and sedentary behaviour. BMI ≥ 30kg/m2 defines an individual to be obese. Although, obesity itself is a morbid disease, it also predisposes an obese individual to various pathologies which are Diabetes Mellitus (type 2), Hypertension, Cardiovascular disorders, Respiratory disorders, early degenerative changes of various joints of the body, depression, and many more. Though there are various benefits of bariatric surgery, up till what duration the benefits are lasting is unclear. Also, whether aerobic and resisted exercise plays a vital role in post bariatric patients or not is unclear. Thus, this study aims to identify effectiveness of aerobic exercise and strength training for post bariatric surgery patients on different parameters of body, that is, Aerobic capacity, Body consumption, physiological and psychological aspects. Random allocation of 120 subjects would be done to control group(n=60) (group A) and experimental group(n=60) (group B). All the parameters will be recorded of all subjects of both groups before undergoing bariatric surgery. Post-surgery after 1-month similar procedure will be done. Exercise intervention will be initiated for group-B as only after permission from bariatric surgeon. Before beginning the protocol, subject’s; Aerobic capacity will be assessed using 6MWT. Strength will be assessed using 1RM BMI and Waist Circumference will be assessed using measure tape and stadiometer Skin fold thickness will be assessed using skin fold calliper HBA1c measurement will be recorded (every 3 months) Scales – BDI & GSRS Pre-intervention session and post intervention subject’s vitals will be recorded to ensure optimum recovery after intervention. The intervention protocol will be of minimum 8 weeks and 3days/week. The recording of all parameters will be taken intermittently within intervals of 4 weeks.
After completion of intervention protocol, recording of all the parameters will be continuously taken for 2 months or till deconditioning effects are observed (whichever is first), with 1month interval between recordings. |