NCT04352517

Brief Summary

The on-going Wuhan coronavirus (COVID-19) outbreak has become the world's leading health headline and is causing major panic and public concerns. On January 30, 2020, the World Health Organization (WHO) declared that the new coronavirus outbreak as a Public Health Emergency of International Concern; and March 11, 2020, characterized COVID-19 as a pandemic. On March, 13, Europe become epicenter of the pandemic all countries in South America had been infected with at least one case. Health authorities, including WHO, have issued safety recommendations for taking simple precautions to reduce exposure to and transmission of the virus. Home stay is a fundamental safety step that can limit infections from spreading widely. Unfortunately, the mandated directives against travelling and participating in outdoor activities will inevitably disrupt the routine daily activities of tens of millions of people. Prolonged home stays may lead to widespread fear and panic, anxiety and depression, which in turn can lead to a sedentary lifestyle. Thus, while quarantine is a safe and priority measure, may have unintended negative consequences. These efforts to avoid human-to-human transmission of the virus may lead to spend excessive amounts of time sitting, reclining or lying down for screening activities (games, television, mobile devices); reducing energy expenditure that, consequently, lead to an increased in a range of chronic health conditions. Therefore, there is a strong health rationale for continuing physical activity in the home to stay healthy and prevent a wide range of psychological problems on people during outbreaks of infection. However, currently, there is no sufficient information on the psychological impact and mental health of the general public during the peak of the COVID-19 epidemic and a timely understanding of mental health status is urgently needed for society. To our knowledge, there are no research examining the psychological and social impact on COVID-19 on the general population. The aim of this research is to determinate the psychological responses in general population in order to understand the anxiety, depression and stress level during Coronavirus Disease (COVID-19) confinement period, and how the level of physical activity development during this exceptional period could be influence.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

April 10, 2020

Last Update Submit

February 19, 2021

Conditions

Keywords

COVID-19

Outcome Measures

Primary Outcomes (6)

  • Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on avoidance impact of COVID-19 through IES-R

    The IPAQ short form will be used to measure physical activity level and the psychological impact of COVID-19 will be measured using the Impact of Event Scale-Revised (IES-R)

    8-15 weeks

  • Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on intrusion impact of COVID-19 through IES-R

    The IPAQ short form will be used to measure physical activity level and the psychological impact of COVID-19 will be measured using the Impact of Event Scale-Revised (IES-R)

    8-15 weeks

  • Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on hyperarousal impact of COVID-19 through IES-R

    The IPAQ short form will be used to measure physical activity level and the psychological impact of COVID-19 will be measured using the Impact of Event Scale-Revised (IES-R)

    8-15 weeks

  • Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on depression health status through DASS-21

    The IPAQ short form will be used to measure physical activity level and mental health status will be measured using the Depression, Anxiety and Stress Scale (DASS-21)

    8-15 weeks

  • IImpact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on anxiety health status through DASS-21

    The IPAQ short form will be used to measure physical activity level and mental health status will be measured using the Depression, Anxiety and Stress Scale (DASS-21)

    8-15 weeks

  • Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on stress health status through DASS-21

    The IPAQ short form will be used to measure physical activity level and mental health status will be measured using the Depression, Anxiety and Stress Scale (DASS-21)

    8-15 weeks

Interventions

Online survey completion through google app.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will adopt a cross-sectional survey design to assess the public's immediate psychological and level of physical activity response during the epidemic of COVID-19 by using an anonymous online questionnaire.

You may qualify if:

  • Subjects since 18 years of age currently in isolation situation
  • Subjects from spanish speaking countries in situation of "Local transmission" by COVID19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universidade da Sao Paulo

Ribeirão Preto, São Paulo, 14.040-907, Brazil

Location

Universidad Autonoma de Chile

Santiago, Santiago Metropolitan, Chile

Location

Universidad de la República

Rivera, Uruguay

Location

Related Publications (7)

  • Zhang MW, Ho CS, Fang P, Lu Y, Ho RC. Methodology of developing a smartphone application for crisis research and its clinical application. Technol Health Care. 2014;22(4):547-59. doi: 10.3233/THC-140819.

    PMID: 24898865BACKGROUND
  • Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. No abstract available.

    PMID: 32032543BACKGROUND
  • Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.

    PMID: 32155789BACKGROUND
  • Owen N, Sparling PB, Healy GN, Dunstan DW, Matthews CE. Sedentary behavior: emerging evidence for a new health risk. Mayo Clin Proc. 2010 Dec;85(12):1138-41. doi: 10.4065/mcp.2010.0444. No abstract available.

    PMID: 21123641BACKGROUND
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND
  • Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.

    PMID: 32099716BACKGROUND
  • Camacho-Cardenosa A, Camacho-Cardenosa M, Merellano-Navarro E, Trape AA, Brazo-Sayavera J. [Influence of physical activity during outbreak on psychological states in adults in the Covid-19 pandemic: a study protocol.]. Rev Esp Salud Publica. 2020 Jun 12;94:e202006063. Spanish.

MeSH Terms

Conditions

Sedentary BehaviorCOVID-19

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alba Dr Camacho-Cardenosa, Doctor

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 20, 2020

Study Start

March 16, 2020

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations