| CTRI Number |
CTRI/2020/11/029124 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of COVID-19 on exercise pattern, diet pattern and weight change in athletes |
|
Scientific Title of Study
|
Impact of COVID-19 on exercise regimen , diet regimen and weight change in athletes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachana |
| Designation |
Student |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742968004 |
| Fax |
|
| Email |
rachana.dahs@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi Acharya |
| Designation |
Assistant Professor- senior scale |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535071393 |
| Fax |
|
| Email |
swathi.acharya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Swathi Acharya |
| Designation |
Assistant Professor- senior scale |
| Affiliation |
Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535071393 |
| Fax |
|
| Email |
swathi.acharya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Welcomgroup Graduate School of Hotel Administration |
|
|
Primary Sponsor
|
| Name |
Rachana |
| Address |
Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education,Manipal |
| 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 |
| Rachana |
Manipal |
Wecomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9742968004
rachana.dahs@learner.manipal.edu |
|
|
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 |
Athletes who practices minimum one hour of sports every day and athletes with minimum one year of being in to sports activity |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Athletes who practices minimum one hour of sports every day and athletes with minimum one year of being in to sports activity. And athletes between the age group of 18 to 30 in spite of any gender. |
|
| ExclusionCriteria |
| Details |
Athletes below and above the age of 18 and 30 respectively and athletes with health issues such as Diabetes Mellitus and the participants who are not willing to participate in the study are excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess the change that has happened in the exercise or practice regimen of the athletes due to covid-19. |
Single interaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess the impact of Covid-19 on nutritional changes that has happened in the diet. And finding the association of the change in exercise regimen and diet regimen on the weight of athletes. |
Single interaction |
|
|
Target Sample Size
|
Total Sample Size="336"
Sample Size from India="336"
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)
|
21/11/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IEC permission will be obtained after which the data collection process gets started. Athletes between the age group of 18 to 30 in spite of any gender are recruited. Information needed to contact the samples like list of athletes and their contact details are collected from physical education directors of MAHE, Manipal and Alva’s College, Moodubidiri. The samples will be asked for their approval through telephone. To those who give their consent to participate in the study, questionnaire will be given to be filled which will include basic personal information like age, gender, weight, habits etc., Food frequency questionnaire, diet recall, their opinion on athletic performance and exercise routine during pandemic etc.. All this will be done with the help of telephone an online platform i.e. MS forms. After the data collection process the data analysis will be done with the help SPSS software and the report will be made. Any participant is allowed to take back their consent in any moment during the study. |