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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361019
Other study ID # Covid_PA2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date May 20, 2021

Study information

Verified date January 2022
Source University of the Basque Country (UPV/EHU)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 14000
Est. completion date May 20, 2021
Est. primary completion date May 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - University students of any degree (bachellor's degree, master's degree, doctorate degree or any other University studies Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
On-Line Survey
A survey has been sent by email to the students of the participating universities

Locations

Country Name City State
Spain Basque Country University (UPV-EHU), Bilbao Bizkaia

Sponsors (16)

Lead Sponsor Collaborator
University of the Basque Country (UPV/EHU) Technical University of Madrid, Universidad de Granada, Universidad de León, Universidad de Zaragoza, Universidad Miguel Hernandez de Elche, Universidad Pública de Navarra, Universitat Jaume I, University of Cadiz, University of Cantabria, University of Castilla-La Mancha, University of Extremadura, University of Las Palmas de Gran Canaria, University of Seville, University of the Balearic Islands, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Bassett DR Jr. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1396. — View Citation

Rodríguez-Muñoz 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Sociodemographic outcomes 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
Other Sociodemographic outcomes 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
Other Sociodemographic outcomes 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
Other COVID-19 related factors 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
Other COVID-19 related factors 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
Other COVID-19 related factors 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
Primary : 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 April-May, 2020
Primary : 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 June 2020
Primary : 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 April-May, 2021
Secondary 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 April-May, 2020
Secondary 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 June, 2020
Secondary 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 April-May, 2021
Secondary 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 April-May 2020
Secondary 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 June, 2020
Secondary 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 April-May, 2021
Secondary 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 April-May, 2020
Secondary 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 June, 2020
Secondary 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 April-May, 2021
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