Physical Activity Clinical Trial
Official title:
Physical Activity in University Students Around COVID-19 Confinement: Determinants and Consequences on Health Status and Quality of Life
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 |
Verified date | January 2022 |
Source | University of the Basque Country (UPV/EHU) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
Spain | Basque Country University (UPV-EHU), | Bilbao | Bizkaia |
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 |
Spain,
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
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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