| CTRI Number |
CTRI/2018/02/011967 [Registered on: 19/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity and Sleep Quality in Correlation to Mental Health among College Students
"The relationship between mental health, physical activity and sleep quality among college students" |
|
Scientific Title of Study
|
Physical Activity and Sleep Quality in Correlation to Mental Health among College Students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences - CPRS, Jamia Millia Islamia, Jamia Nagar
New Delhi
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
majuminoohu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amer Ghrouz |
| Designation |
PG - Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences - CPRS, Jamia Millia Islamia, Jamia Nagar
New Delhi
DELHI
110025
India |
| Phone |
7838855904 |
| Fax |
|
| Email |
a.k.ghrouz@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amer Ghrouz |
| Designation |
PG - Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences - CPRS, Jamia Millia Islamia, Jamia Nagar
New Delhi
DELHI
110025
India |
| Phone |
7838855904 |
| Fax |
|
| Email |
a.k.ghrouz@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Centre of Physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marge, Jamia Nagar, New Delhi - 110025
New Delhi
DELHI
110025
India
|
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Nagar, New Delhi |
| Type of Sponsor |
Other [Central University ] |
|
|
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 Majumi M Noohu |
Jamia Millia Islamia |
Centre of Physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marge, Jamia Nagar, New Delhi - 110025
New Delhi
DELHI
110025
India
New Delhi
DELHI |
9868023378
majuminoohu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The study will conduct university students, from different departments among designed age from both genders |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between 18-30 years of age, male and female students and either physically active or inactive students.
Able to follow the instructions and having knowledge in English language. |
|
| ExclusionCriteria |
| Details |
Physically challenged individuals, and who had contraindications for physical activity.
Clinically diagnosed primary sleep disorder by an appropriate medical consultant (e.g. sleep apnea and primary insomnia)
People with any confounding conditions, such as a neurologic, medical or surgical disorder.
History of sleeping disorders or any systematic disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mental health
Physical activity
Sleep Quality
Mental health, Physical activity, Sleep Quality assessment through out the duration of three months ( February-April/ 2018) to give the primary assessment and final outcomes will be prepared by May/ 2018
|
One time point
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mental health, Physical activity, Sleep Quality assessment which was conducted in the primary outcomes of three months ( February-April/ 2018) which then will be finalized by the second week of May/ 2018 |
One time point |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "662"
Final Enrollment numbers achieved (India)="662" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
16/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/04/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not available (Not Yet) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational study. The aim of this study is to examine the associations and the interactive effects of physical activity, sleep quality and mental health (including anxiety and depression) among Indian college students by self-reported Physical Activity, Sleeping Quality and Mental Health questionnaires, to improve health quality of college students. |