| CTRI Number |
CTRI/2024/06/069244 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [exercise intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of combined home based exercise and aerobic exercise intervention on skinny fat young adult male participants |
|
Scientific Title of Study
|
Effect of home based exercise regimen in improving body composition and cardiometabolic parameters in young adults with normal weight obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya Pradeep Karnad |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
Physiology department,
Kasturba Medical College and Hospital Manipal,
Madhav Nagar,
Manipal
Udupi KARNATAKA 576102 India |
| Phone |
9980129891 |
| Fax |
|
| Email |
karnad.aditya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dhiren D Punja |
| Designation |
Head of department |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
HOD, Physiology department,
Kasturba Medical College and Hospital Manipal,
Madhav Nagar,
Manipal
Udupi KARNATAKA 576102 India |
| Phone |
9845558131 |
| Fax |
|
| Email |
dhiren.punja@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Aditya Pradeep Karnad |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
Physiology department,
Kasturba Medical College and Hospital Manipal,
Madhav Nagar,
Manipal
Udupi KARNATAKA 576102 India |
| Phone |
9980129891 |
| Fax |
|
| Email |
karnad.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHE Post graduate research grant,
Research Directorate Office
Manipal Academy of Higher Education
Manipal - 576 104, Karnataka India |
|
|
Primary Sponsor
|
| Name |
MAHE Post graduate research grant |
| Address |
Directorate of Research
MAHE Grants office
Ground Floor, Tower 3, Behind Melaka Manipal Medical College, (MMMC)
Advanced Research Center, Manipal Academy of Higher Education, Manipal- 576104, India |
| 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 Aditya Pradeep Karnad |
Kasturba Medical College Manipal |
Amphibian lab,
Physiology department
Udupi KARNATAKA |
9980129891
karnad.aditya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy normal weight obese young adult males in the age group of 18-30 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Home based resistance and aerobic exercise regimen |
Resistance training regimen consists of multiple home based body weight resistance exercises, which target multiple muscle groups with 2 days of the week consisting of multiple exercises.
Aerobic exercises consists of jogging, walking or running according to the preference of the participant |
| Comparator Agent |
Control group |
Control group will also undergo investigations as the exercise group, but they will not be performing the exercise regimen. After a duration of 12 weeks they will be followed up with the repeat of the investigations |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
1. Male participants will be taken from the student population of MAHE institution.
2. Participants will be from the ages of 18 to 30 years.
3. Participants with body fat percentage above 23.1%9 and with a BMI within the normal range– that is, above 18.5 kg/m2 to 24.9 kg/m2 (thus including both groups under normal weight and overweight categories).
4.Participants who have MET less than 4.0 will be included in the study after the participants answer the GPAQ questionnaire.
|
|
| ExclusionCriteria |
| Details |
1. Participants having a history of cardiovascular disease and renal disease will be excluded from the study (as it interferes with the body composition assessment).
2. Participants will be excluded from the study if they are unable to perform the exercise regimen, due to musculoskeletal injury, cardiovascular disease history, etc,.
3. Participants having type I diabetes mellitus will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.BMI
2.Fat free mass
3.FFMI (index)
4.Body fat percentage
5.Body fat mass index(BFMI)
6.Waist/hip ratio
7.LDL, HLD, Serum triglycerides, total cholesterol
8. Fasting blood glucose, Fasting insulin, Insulin sensitivity (HOMA-IR)
9.Anthropometric measures such as waist circumference, hip circumference, waist to hip ratio and skin fold thickness at pectoral, abdomen and thigh
10. Blood pressure |
Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Waist/hip ratio
2.LDL, HLD, Serum triglycerides, total cholesterol
3. Fasting blood glucose, Fasting insulin, Insulin sensitivity (HOMA-IR)
4.Anthropometric measures such as waist circumference, hip circumference, waist to hip ratio and skin fold thickness at pectoral, abdomen and thigh
5. Blood pressure |
Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen |
|
|
Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
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)
|
01/07/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [karnad.aditya@gmail.com].
- For how long will this data be available start date provided 10-05-2025 and end date provided 10-05-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Studies have found that there is an increasing prevalence of obesity
globally .There is also a similar growing prevalence of obesity in the Indian
population . Studies have predicted that the prevalence
of overweight will more than double among Indian adults aged 20–69 years
between 2010 and 2040, while the prevalence of obesity will triple. And also as a result of which, there will be an increase in the prevalence of lifestyle related disorders
such as cardiovascular disease and diabetes mellitus affecting not only an
increased portion of the population but also a younger demographic. Obesity,
which is defined based mainly on the Body mass index ( above range of >25
kg/m2 in the Indian population), has
been associated with an increasing association with cardiovascular disease,
insulin resistance and type II diabetes mellitus. Recent
studies have also found that there is a strong
association of abdominal adiposity and the complications associated with
obesity such as diabetes mellitus, cardiovascular disease.
However, BMI as a tool does not
differentiate between lean body mass and body fat percentage. As a result of which, a
portion of the population who have a higher body fat percentage and a higher
percentage of visceral fat (therefore associated
with greater risks of morbidity and mortality)
will not be screened and treated.
Normal weight obesity is defined as individuals with normal
BMI (that is 18.9kg/m2 to 22.9kg/m2 and overweight under 23.0km/m2 to 24.9
kg/m2) that have an increased body fat percentage. There is a lack of literature on the incidence of normal weight obesity in the Indian
population, who, due to their carbohydrate rich diet and increasingly sedentary lifestyle, are more prone to normal weight obesity.
There is also a lack of literature on the
effects of exercise on the body composition of normal weight obesity
individuals. Especially in the young adult population who are more prone to
pick up the lifestyle habits. An increased
involvement of physical exercise in the lifestyle of these individuals might be
associated with reducing the incidence of non communicable diseases such as
cardiovascular diseases and diabetes mellitus. The use of body fat percentage
would also help identify the hidden part of the iceberg, consisting of cases who have a higher risk of suffering from
non-communicable diseases that go undetected with an ineffective
screening test like BMI. |