- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361019
Physical Activity in University Students Around COVID-19 Confinement
January 1, 2022 updated by: Jon Irazusta, University of the Basque Country (UPV/EHU)
Physical Activity in University Students Around COVID-19 Confinement: Determinants and Consequences on Health Status and Quality of Life
The period of confinement due to COVID-19 may lead to reduced physical activity levels with negative consequences for health and quality of life in the short and long term, in case the sedentary habits are maintained over time.
It is therefore essential to know the physical activity and health habits of university students during the confinement, as it could help in the design of effective strategies for the post-confinement period, as well as for any similar future situations.
The general objective of the study is to know how university students have adapted their physical activity and health habits to the situation of confinement generated by COVID-19, as well as to identify the determining factors and the possible consequences.
It is expected that there will be modifications in the patterns of physical activity in this situation, which could vary based on sociodemographic and economic determinants, and could affect parameters of health and quality of life.
A survey will be sent to all students by email through the corresponding vice-rectorates of the sixteen participating universities (https://covid19.ehu.es/).
The survey will be completed "online" anonymously.
Among those participants who wish to keep participating in the study, a follow-up will be carried out one month and one year after the end of the confinement period.
In this case, those subjects must indicate their willingness to keep participating and provide a contact email.
The follow-up period will allow to know how physical activity and health habits are modified in the long term.
Study Overview
Study Type
Observational
Enrollment (Actual)
14000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bizkaia
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Bilbao, Bizkaia, Spain, 48940
- Basque Country University (UPV-EHU),
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All University students from the 16 Universities participating in the study will be invited to answer the online survey.
The total amount of students in the 16 universities is around 500,000.
The sample will include students in different academic degrees: bachelor's degree, master's degree, doctorate degree or any other University studies.
Description
Inclusion Criteria:
- University students of any degree (bachellor's degree, master's degree, doctorate degree or any other University studies
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
: International Physical Activity Questionnaire - Short Form
Time Frame: April-May, 2020
|
7-item questionnaire regarding last 7 days' physical activity and sedentary behavior.
Vigorous, moderate and walking physical activities will be measured in METS (metabolic equivalent of task) per week, and sedentary behavior will be collected as sedentary time per day
|
April-May, 2020
|
|
: International Physical Activity Questionnaire - Short Form
Time Frame: June 2020
|
7-item questionnaire regarding last 7 days' physical activity and sedentary behavior.
Vigorous, moderate and walking physical activities will be measured in METS (metabolic equivalent of task) per week, and sedentary behavior will be collected as sedentary time per day
|
June 2020
|
|
: International Physical Activity Questionnaire - Short Form
Time Frame: April-May, 2021
|
7-item questionnaire regarding last 7 days' physical activity and sedentary behavior.
Vigorous, moderate and walking physical activities will be measured in METS (metabolic equivalent of task) per week, and sedentary behavior will be collected as sedentary time per day
|
April-May, 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains
Time Frame: April-May, 2020
|
19-item self-report questionnaire assessing 7 domains regarding sleep.
Only item number 4 (corresponding to subjective sleep quality domain) and item number 6 (corresponding to sleep duration domain) will be measured
|
April-May, 2020
|
|
Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains
Time Frame: June, 2020
|
19-item self-report questionnaire assessing 7 domains regarding sleep.
Only item number 4 (corresponding to subjective sleep quality domain) and item number 6 (corresponding to sleep duration domain) will be measured
|
June, 2020
|
|
Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains
Time Frame: April-May, 2021
|
19-item self-report questionnaire assessing 7 domains regarding sleep.
Only item number 4 (corresponding to subjective sleep quality domain) and item number 6 (corresponding to sleep duration domain) will be measured
|
April-May, 2021
|
|
Short Form 36 Health Survey: Bodily Pain domain
Time Frame: April-May 2020
|
The Short Form 36 Health Survey is a 36 -item self-report questionnaire assessing 8 domains regarding health-related quality of life.
Only items number 7 and 8 (corresponding to bodily pain domain) will be measured.
A score ranging from 0 to 100 is obtained, with higher scores indicating a better bodily pain related quality of life
|
April-May 2020
|
|
Short Form 36 Health Survey: Bodily Pain domain
Time Frame: June, 2020
|
The Short Form 36 Health Survey is a 36 -item self-report questionnaire assessing 8 domains regarding health-related quality of life.
Only items number 7 and 8 (corresponding to bodily pain domain) will be measured.
A score ranging from 0 to 100 is obtained, with higher scores indicating a better bodily pain related quality of life
|
June, 2020
|
|
Short Form 36 Health Survey: Bodily Pain domain
Time Frame: April-May, 2021
|
The Short Form 36 Health Survey is a 36 -item self-report questionnaire assessing 8 domains regarding health-related quality of life.
Only items number 7 and 8 (corresponding to bodily pain domain) will be measured.
A score ranging from 0 to 100 is obtained, with higher scores indicating a better bodily pain related quality of life
|
April-May, 2021
|
|
EuroQol 5D: Self rated health
Time Frame: April-May, 2020
|
The EuroQol 5D is a self-report questionnaire to assess five health-related domains.
Only the item assessing the overall self-rated health status will be used.
In the traditional questionnaire, participants are asked to rate their current health status in a 0-100 visual analogue scale, with "0" corresponding to "the worst health you can imagine" and "100" to "the best health you can imagine".
A modified version using a 0-10 numerical rating scale will be used, in order to adapt it to an online format
|
April-May, 2020
|
|
EuroQol 5D: Self rated health
Time Frame: June, 2020
|
The EuroQol 5D is a self-report questionnaire to assess five health-related domains.
Only the item assessing the overall self-rated health status will be used.
In the traditional questionnaire, participants are asked to rate their current health status in a 0-100 visual analogue scale, with "0" corresponding to "the worst health you can imagine" and "100" to "the best health you can imagine".
A modified version using a 0-10 numerical rating scale will be used, in order to adapt it to an online format
|
June, 2020
|
|
EuroQol 5D: Self rated health
Time Frame: April-May, 2021
|
The EuroQol 5D is a self-report questionnaire to assess five health-related domains.
Only the item assessing the overall self-rated health status will be used.
In the traditional questionnaire, participants are asked to rate their current health status in a 0-100 visual analogue scale, with "0" corresponding to "the worst health you can imagine" and "100" to "the best health you can imagine".
A modified version using a 0-10 numerical rating scale will be used, in order to adapt it to an online format
|
April-May, 2021
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic outcomes
Time Frame: April-May, 2020
|
Sociodemographic variables will include age, gender, height, weight, residence (place and family unit type and size), academic data (University, branch of knowledge and academic degree) and smoking habits
|
April-May, 2020
|
|
Sociodemographic outcomes
Time Frame: June, 2020
|
Sociodemographic variables will include age, gender, height, weight, residence (place and family unit type and size), academic data (University, branch of knowledge and academic degree) and smoking habits
|
June, 2020
|
|
Sociodemographic outcomes
Time Frame: April-May, 2021
|
Sociodemographic variables will include age, gender, height, weight, residence (place and family unit type and size), academic data (University, branch of knowledge and academic degree) and smoking habits
|
April-May, 2021
|
|
COVID-19 related factors
Time Frame: April-May, 2020
|
Participants will be asked if: a) they have had COVID-19 related symptoms, b) have been diagnosed with COVID-19 by a health professional or c) have been living with a person diagnosed with COVID-19 during the confinement
|
April-May, 2020
|
|
COVID-19 related factors
Time Frame: June, 2020
|
Participants will be asked if: a) they have had COVID-19 related symptoms, b) have been diagnosed with COVID-19 by a health professional or c) have been living with a person diagnosed with COVID-19 during the confinement
|
June, 2020
|
|
COVID-19 related factors
Time Frame: April-May, 2021
|
Participants will be asked if: a) they have had COVID-19 related symptoms, b) have been diagnosed with COVID-19 by a health professional or c) have been living with a person diagnosed with COVID-19 during the confinement
|
April-May, 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jon Irazusta, PhD, Basque Country University (UPV-EHU), Leioa, Bizkaia, 48940, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bassett DR Jr. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1396. doi: 10.1249/01.MSS.0000078923.96621.1D. No abstract available.
- Rodriguez-Munoz S, Corella C, Abarca-Sos A, Zaragoza J. Validation of three short physical activity questionnaires with accelerometers among university students in Spain. J Sports Med Phys Fitness. 2017 Dec;57(12):1660-1668. doi: 10.23736/S0022-4707.17.06665-8. Epub 2017 Mar 1.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2020
Primary Completion (Actual)
May 20, 2020
Study Completion (Actual)
May 20, 2021
Study Registration Dates
First Submitted
April 22, 2020
First Submitted That Met QC Criteria
April 23, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 1, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Covid_PA2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
All individual data of the participants, with the exception of the email, the university and where they live, will be available upon reasonable request.
IPD Sharing Time Frame
The data will become available once the study will finish
IPD Sharing Access Criteria
The access to individual participant data will be decided after analysing each request taking into account the scientific quality of the proposal
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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