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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Spain
    • Bizkaia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the Basque Country (UPV/EHU)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of the Balearic Islands
University of Extremadura
Universitat Jaume I
University of Valencia
Universidad Pública de Navarra
Universidad de Granada
Universidad de Zaragoza
University of Seville
Universidad Miguel Hernandez de Elche
University of Cadiz
Universidad de León
University of Castilla-La Mancha
University of Las Palmas de Gran Canaria
Technical University of Madrid
University of Cantabria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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