| CTRI Number |
CTRI/2018/08/015153 [Registered on: 01/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study to Study Association Between Sleep Quality And Physical Fitness Components Among 18-25 Years College Students |
|
Scientific Title of Study
|
Association Between Sleep Quality And Physical Fitness Components Among 18-25 years College Students- A Cross Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khunt Dhara Shambhubhai |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Srinivas college of Physiotherapy |
| Address |
Physiotherapy Department, Musculoskeletal OPD, President A Shama Rao Foundation, GHS Road, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9537326999 |
| Fax |
|
| Email |
dharakhunt2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Mageswaran |
| Designation |
Associate Professor |
| Affiliation |
Srinivascollege of Physiotherapy |
| Address |
Physiotherapy Department, Musculoskeletal OPD, President A Shama Rao Foundation, GHS Road, Mangaluru,
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
mageshnbpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Mageswaran |
| Designation |
Associate Professor |
| Affiliation |
Srinivascollege of Physiotherapy |
| Address |
Physiotherapy Department, Musculoskeletal OPD, President A Shama Rao Foundation, GHS Road, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
|
| Fax |
|
| Email |
mageshnbpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Srinivas college of Physiotherapy and Research Centre, President A Shama Rao Foundation, GHS Road, Mangaluru, Karnataka 575001 |
|
|
Primary Sponsor
|
| Name |
Srinivas College of Physiotherapy and Research Centre |
| Address |
Srinivas College of Physiotherapy and Research Centre, A Shama Rao Foundation, GHS Road, Mangaluru, Karnataka 575001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dhara Khunt |
Srinivas College of Physiotherapy |
Physiotherapy Department, Musculoskeletal OPD, President A Shama Rao Foundation, GHS Road, Mangaluru,Karnataka 575001
Dakshina Kannada
KARNATAKA |
9537326999
dharakhunt2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Individuals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
BMI - less than or equal to 25 kg/m2 |
|
| ExclusionCriteria |
| Details |
1)History of mental or physical impairments which lead to inability to exercise
2)History of smoking (1-4 cigarettes per day)
3)History of known cardio-respiratory disease
4)History of known metabolic disease
5)History of known orthopedic disease
6)History of being physical active more than 150 min per week
7)History of consuming more than 400 gm caffeine per day |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1-RM Leg Press Test |
One time measurement will be there so outcome will be taken after data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PSQI questionnaire
Back-saver sit and reach test
sit-up test
20-m shuttle run test |
PSQI questionnaire will be taken immediately after data collection and after that rest of all outcomes will be taken |
|
|
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)
|
03/08/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Physical
fitness can be thought as an integrated measure of the body functions
(skeletomuscular, cardiorespiratory,
psychoneurological) involved in the performance of daily physical activity. Physical fitness is strongly associated with cardiovascular, musculoskeletal,
and psychological health. Disorders in any of these functions and poor
nutritional status can influence physical fitness negatively.
Not only nutritional and daily habits, but also
the nocturnal habits are factors which can influence physical fitness.
Previous studies
regarding sleep and physical fitness focused on adolescents, middle and older
aged population but
not focused on young adults to know whether there is a same pattern observe or
not. Therefore, this study is intended to find out association between sleep
quality and physical fitness among college students.
|