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Physical ActivityNCT04361019

Physical Activity in University Students Around COVID-19 Confinement

An observational study of Physical Activity, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Physical Activity
What is being tested?
On-Line Survey
How many people
14,000 participants
Where
1 siteSpain
Study dates
16 Apr 2020to 20 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • University students of any degree (bachellor's degree, master's degree, doctorate degree or any other University studies

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Basque Country University (UPV-EHU),

    Bilbao, Bizkaia, 48940

Other trials in Spain

About this study

Official title: 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.

Being tested
On-Line Survey
Keywords
University Students, Survey, COVID-19, Confinement, Physical Activity, Quality of Life, Health, Sleep, Pain
Medical subject headings
Motor Activity, COVID-19, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On-Line SurveyOther

    A survey has been sent by email to the students of the participating universities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. : International Physical Activity Questionnaire - Short Form

    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

    Measured: April-May, 2020

  2. : International Physical Activity Questionnaire - Short Form

    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

    Measured: June 2020

  3. : International Physical Activity Questionnaire - Short Form

    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

    Measured: April-May, 2021

Secondary outcomes (9)

  1. Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains

    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

    Measured: April-May, 2020

  2. Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains

    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

    Measured: June, 2020

  3. Pittsburgh Sleep Quality Index: Subjective Sleep Quality and Sleep Duration domains

    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

    Measured: April-May, 2021

  4. Short Form 36 Health Survey: Bodily Pain domain

    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

    Measured: April-May 2020

  5. Short Form 36 Health Survey: Bodily Pain domain

    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

    Measured: June, 2020

  6. Short Form 36 Health Survey: Bodily Pain domain

    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

    Measured: April-May, 2021

  7. EuroQol 5D: Self rated health

    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

    Measured: April-May, 2020

  8. EuroQol 5D: Self rated health

    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

    Measured: June, 2020

  9. EuroQol 5D: Self rated health

    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

    Measured: April-May, 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start16 Apr 2020
  3. Primary completion20 May 2020
  4. Study completion20 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
14,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361019
Sponsor's protocol ID
Covid_PA2020
Status last verified
Jan 2022
First submitted
22 Apr 2020
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual data of the participants, with the exception of the email, the university and where they live, will be available upon reasonable request.

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.

    PubMed 12900695

  • 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.

    PubMed 28249383

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Activity, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

: International Physical Activity Questionnaire - Short Form (time frame: April-May, 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361019, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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