| CTRI Number |
CTRI/2025/10/096272 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating the Effects of Calisthenic and Resistance Band Exercises on Physical Fitness, Blood Biomarkers (Triglycerides, Cholesterol, Leptin, Adiponectin, HbA1c), and Psychological Well-being in Overweight Adults. |
|
Scientific Title of Study
|
A Comparative Study of Calisthenics and Resistance Band Exercises on Physical Fitness, Blood Biomarkers, and Psychological Well-Being in Overweight Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surabhi Chauhan |
| Designation |
PhD Scholar |
| Affiliation |
Sharda university, Greater noida |
| Address |
Room 502-B, Department of Physiotherapy, Sharda School of Allied Health Sciences, Sharda University, Knowledge Park III, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9711708417 |
| Fax |
|
| Email |
2024104035.surabhi@dr.sharda.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gaurav Kaushik |
| Designation |
Professor |
| Affiliation |
Sharda University, greater noida |
| Address |
Room 504, Sharda School of Allied Health Sciences, Sharda University, Knowledge Park III, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9953193296 |
| Fax |
|
| Email |
gaurav.kaushik@sharda.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Gaurav Kaushik |
| Designation |
Professor |
| Affiliation |
Sharda University, greater noida |
| Address |
Room 504, Sharda School of Allied Health Sciences, Sharda University, Knowledge Park III, greater noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9953193296 |
| Fax |
|
| Email |
gaurav.kaushik@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surabhi Chauhan |
| Address |
502-B Department of Physiotherapy, Sharda School of Allied Health and Sciences, Sharda University, Greater Noida, 201310 |
| Type of Sponsor |
Other [Self-Sponsored] |
|
|
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 Gaurav kaushik |
Sharda University |
Sharda university, knowledge park III, greater noida Gautam Buddha Nagar UTTAR PRADESH |
9953193296
gaurav.kaushik@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of the School of Medical Sciences and Research & Sharda Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calisthenics |
Participants will perform Calisthenics for 4 days in a week X 24 weeks. |
| Comparator Agent |
Control |
Participants will continue their regular daily activities without any specific intervention |
| Intervention |
Resistance Band |
Participants will perform Resistance band exercises for 4 days in a week X 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 45 years
Overweight (BMI 25 – 29.9 )
Sedentary (less than 600 MET-min/week- IPAQ)
Adults with altered biomarkers, including triglycerides from 150 mg/dL to 199 mg/dL, HDL cholesterol less than 40 mg/dL for men and less than 50 mg/dL for women, LDL cholesterol from 100 mg/dL to 159 mg/dL, leptin greater than 15 ng/mL for men and greater than 30 ng/mL for women, adiponectin less than 4 micrograms/mL for men and less than 5 micrograms/mL for women, and HbA1c from 5.7 percent to 6.4 percent
Candidates who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Person with history of any recent injury or surgery
Person with history of any musculoskeletal, neurological, cardiopulmonary or any other diseases or disorders
Person involved in any type of drugs or alcohol consumption
Person practicing any other form of exercise
Dieting
Pregnancy
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Physcical fitness
i.Balance (Y-balance test)
ii.Cardiovascular fitness (6 minute walk test)
iii.Flexibility (Sit and reach test)
iv.Abdominal strength and endurance (Curl up test)
v.Strength (Dynamometer)
2) Blood biomarkers
i. Triglyceride
ii. Cholestrol
iii. HDL
iv. LDL
v. Leptin
vi. Adiponectin
vii. HBA1c |
Assessed at Baseline
at week 12
at week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3) Psychological well being (Warwick-Edinburgh Mental Well-Being Scale) |
Assessed at Baseline
At week 12
At week 24 |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
01/11/2025 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Calisthenics refers to a form of exercise
regimen that relies solely on utilizing your body weight and a set of movements
that may be done without the need of any tools or apparatus. The calisthenics
exercises have been developed with the goal of providing ideal balance,
adequate, and high efficiency in order to accomplish daily walking applications. Calisthenics is an
adaptable and effective exercise that can be modified according to various
levels of effort. Calisthenics exercises can engage both large and small muscle
groups. Resistance band exercises had been proposed as a form of workout that is
cost-effective, portable, space-efficient, and beneficial for enhancing muscle
strength, balance, flexibility and vascular function among older individuals. Resistance bands provide portability and
safety while allowing for movements similar to those used in competitive
settings.Due to their simplicity, affordability, and safety benefits, elastic
bands are frequently integrated into rehabilitation programs and are readily
accessible in most rehabilitation facilities. The World Health Organization (WHO) and the National Institute of Health
(NIH) have formed a straightforward and accessible method for defining obesity
and overweight, which relies on body mass index (BMI). Obesity affects people of all ages, including
the elderly, adolescents, adults, and children. Globally, the occurance of
overweight and obesity is rising rapidly and has reached epidemic levels in
nearly every nation.
Overweight or obesity
elevates the risk of several health conditions, including type 2 diabetes
mellitus (DM2), cardiovascular diseases, various cancers, non-alcoholic fatty
liver disease, a range of musculoskeletal issues, and mental health challenges.
The gap in current research lies in understanding
the specific effects of calisthenics and resistance band training in overweight individuals, Investigating the
combined effects of calisthenics and resistance band training in overweight
individuals could enhance exercise recommendations for managing weight-related
conditions.
|