Sedentary BehaviorNCT04352517
Influence Physical Activity Psychological Responses COVID-19 Pandemic
An observational study of Sedentary Behavior and Mental Health Wellness 1, run by University of Extremadura at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Mental Health Wellness 1
- What is being tested?
- Online Survey
- How many people
- 3,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 16 Mar 2020to 30 Sep 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Subjects since 18 years of age currently in isolation situation
- Subjects from spanish speaking countries in situation of "Local transmission" by COVID19
Who cannot join
- -
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Influence of Physical Activity on Psychological Responses During Coronavirus Disease (COVID-19) Pandemic: a Multi-center and Observational Study
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.
Read the detailed description
Setting and Participants The investigators 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. A snowball sampling strategy, focus on recruiting the general public living in Ibero-America countries during the epidemic of COVID-19, will be utilized. The online survey will be first disseminated to contacts and participants will be encouraged to pass it on to others.
Procedure As the Governments recommended the public to minimize face-to-face interaction and isolate themselves at home, potential respondents will be electronically invited by existing study respondents. Participants will complete the questionnaires in Spanish through an online survey platform (Google Forms). Information about this study was posted on a dedicated website. All respondents will be provided with informed consent. Data collection will take place over the confinement period.
Survey Development Previous surveys on the psychological impacts of SARS and influenza outbreaks were reviewed. The structured questionnaire consists of questions that covered several areas: (1) demographic data; (2) physical symptoms in the past 14 days; (3) contact history with COVID-19 in the past 14 days; (4) the psychological impact of the COVID-19 outbreak; (5) mental health status; and (6) level of physical activity.
Sociodemographic data will be collected on gender, age, education, residential location days, marital status, employment status, monthly income, parental status, and household size. Physical symptom variables in the past 14 days included fever, chills, headache, myalgia, cough, difficulty in breathing, dizziness, coryza, sore throat, and persistent fever, as well as persistent fever and cough or difficulty breathing. Health service utilization variables in the past 14 days will include consultation with a doctor in the clinic, admission to the hospital, being quarantined by a health authority, and being tested for COVID-19. Contact history variables will include close contact with an individual with confirmed COVID-19, indirect contact with an individual with confirmed COVID-19, and contact with an individual with suspected COVID-19 or infected materials.
The psychological impact of COVID-19 will be measured using the Impact of Event Scale-Revised (IES-R). The IES-R is a self-administered questionnaire that has been well-validated in the Spanish population for determining the extent of psychological impact after exposure to a public health crisis within one week of exposure. This 22-item questionnaire is composed of three subscales and aims to measure the mean avoidance, intrusion, and hyperarousal. The total IES-R score will be divided into 0-23 (normal), 24-32 (mild psychological impact), 33-36 (moderate psychological impact), and >37 (severe psychological impact).
Mental health status will be measured using the Depression, Anxiety and Stress Scale (DASS-21) and calculations of scores will be based on the previous study. Questions 3, 5, 10, 13, 16, 17 and 21 will form the depression subscale. The total depression subscale score will be divided into normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27), and extremely severe depression (28-42). Questions 2, 4, 7, 9, 15, 19, and 20 will form the anxiety subscale. The total anxiety subscale score will be divided into normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). Questions 1, 6, 8, 11, 12, 14, and 18 will form the stress subscale. The total stress subscale score will be divided into normal (0-10), mild stress (11-18), moderate stress (19-26), severe stress (27-34), and extremely severe stress (35-42). The DASS has been demonstrated to be a reliable and valid measure in assessing mental health in the Spanish population. The DASS was previously used in research related to SARS.
The IPAQ short form will be used to measure physical activity level. Total physical activity metabolic equivalent of task (MET)-minutes/ week will be calculated through the following formula: sum of walking + moderate + vigorous MET-minutes/week scores. Using guidelines for data processing and analysis of the IPAQ, participants will be divided into those who are (≥600 MET-minutes/week) and those who are not (<600 MET-minutes/week) sufficiently active. The IPAQ has been validated in adult populations from different countries showing acceptable validity (Spearman's ρ = 0.30, 95% CI: 0.23-0.36) and reliability (Spearman's ρ = 0.81, 95% CI: 0.79-0.82).
Statistical Analysis Descriptive statistics will be calculated for sociodemographic characteristics, physical symptoms and health service utilization variables, and additional health information variables. Percentages of response will be calculated according to the number of respondents per response with respect to the number of total responses of a question. The scores of the IES-R and DASS subscales will be expressed as mean and standard deviation. The investigators will be linear regressions to calculate the univariate associations between sociodemographic characteristics, physical symptom and health service utilization variables, contact history variables, additional health information variables, and the IES-S score as well as the subscales of the DASS and level of physical activity. All tests will be two-tailed, with a significance level of p < 0.05. Statistical analysis will be performed using SPSS Statistic 21.0 (IBM SPSS Statistics, New York, United States).
- Conditions
- Sedentary Behavior, Mental Health Wellness 1
- Being tested
- Online Survey
- Keywords
- COVID-19
- Medical subject headings
- Sedentary Behavior, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyOther
Online survey completion through google app.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8-15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start16 Mar 2020
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Camacho-Cardenosa, University of Extremadura
- Investigators
- Alba Dr Camacho-Cardenosa, Doctor, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352517
- Sponsor's protocol ID
- 3.954.038
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24898865Xiang 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.
PubMed 32032543Wang 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.
PubMed 32155789Owen 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.
PubMed 21123641Craig 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.
PubMed 12900694Chen 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.
PubMed 32099716Camacho-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.
PubMed 32527993
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Activity on Psychological Responses During Coronavirus Disease (COVID-19) Pandemic: a Multi-center and Observational Study
- ClinicalTrials.gov ID
- NCT04352517
- Acronym / sponsor ID
- 3.954.038
- Conditions
- Sedentary Behavior, Mental Health Wellness 1
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Setting and Participants The investigators 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. A snowball sampling strategy, focus on recruiting the general public living in Ibero-America countries during the epidemic of COVID-19, will be utilized. The online survey will be first disseminated to contacts and participants will be encouraged to pass it on to others.
Procedure As the Governments recommended the public to minimize face-to-face interaction and isolate themselves at home, potential respondents will be electronically invited by existing study respondents. Participants will complete the questionnaires in Spanish through an online survey platform (Google Forms). Information about this study was posted on a dedicated website. All respondents will be provided with informed consent. Data collection will take place over the confinement period.
Survey Development Previous surveys on the psychological impacts of SARS and influenza outbreaks were reviewed. The structured questionnaire consists of questions that covered several areas: (1) demographic data; (2) physical symptoms in the past 14 days; (3) contact history with COVID-19 in the past 14 days; (4) the psychological impact of the COVID-19 outbreak; (5) mental health status; and (6) level of physical activity.
Sociodemographic data will be collected on gender, age, education, residential location days, marital status, employment status, monthly income, parental status, and household size. Physical symptom variables in the past 14 days included fever, chills, headache, myalgia, cough, difficulty in breathing, dizziness, coryza, sore throat, and persistent fever, as well as persistent fever and cough or difficulty breathing. Health service utilization variables in the past 14 days will include consultation with a doctor in the clinic, admission to the hospital, being quarantined by a health authority, and being tested for COVID-19. Contact history variables will include close contact with an individual with confirmed COVID-19, indirect contact with an individual with confirmed COVID-19, and contact with an individual with suspected COVID-19 or infected materials.
The psychological impact of COVID-19 will be measured using the Impact of Event Scale-Revised (IES-R). The IES-R is a self-administered questionnaire that has been well-validated in the Spanish population for determining the extent of psychological impact after exposure to a public health crisis within one week of exposure. This 22-item questionnaire is composed of three subscales and aims to measure the mean avoidance, intrusion, and hyperarousal. The total IES-R score will be divided into 0-23 (normal), 24-32 (mild psychological impact), 33-36 (moderate psychological impact), and >37 (severe psychological impact).
Mental health status will be measured using the Depression, Anxiety and Stress Scale (DASS-21) and calculations of scores will be based on the previous study. Questions 3, 5, 10, 13, 16, 17 and 21 will form the depression subscale. The total depression subscale score will be divided into normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27), and extremely severe depression (28-42). Questions 2, 4, 7, 9, 15, 19, and 20 will form the anxiety subscale. The total anxiety subscale score will be divided into normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). Questions 1, 6, 8, 11, 12, 14, and 18 will form the stress subscale. The total stress subscale score will be divided into normal (0-10), mild stress (11-18), moderate stress (19-26), severe stress (27-34), and extremely severe stress (35-42). The DASS has been demonstrated to be a reliable and valid measure in assessing mental health in the Spanish population. The DASS was previously used in research related to SARS.
The IPAQ short form will be used to measure physical activity level. Total physical activity metabolic equivalent of task (MET)-minutes/ week will be calculated through the following formula: sum of walking + moderate + vigorous MET-minutes/week scores. Using guidelines for data processing and analysis of the IPAQ, participants will be divided into those who are (≥600 MET-minutes/week) and those who are not (<600 MET-minutes/week) sufficiently active. The IPAQ has been validated in adult populations from different countries showing acceptable validity (Spearman's ρ = 0.30, 95% CI: 0.23-0.36) and reliability (Spearman's ρ = 0.81, 95% CI: 0.79-0.82).
Statistical Analysis Descriptive statistics will be calculated for sociodemographic characteristics, physical symptoms and health service utilization variables, and additional health information variables. Percentages of response will be calculated according to the number of respondents per response with respect to the number of total responses of a question. The scores of the IES-R and DASS subscales will be expressed as mean and standard deviation. The investigators will be linear regressions to calculate the univariate associations between sociodemographic characteristics, physical symptom and health service utilization variables, contact history variables, additional health information variables, and the IES-S score as well as the subscales of the DASS and level of physical activity. All tests will be two-tailed, with a significance level of p < 0.05. Statistical analysis will be performed using SPSS Statistic 21.0 (IBM SPSS Statistics, New York, United States).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Subjects since 18 years of age currently in isolation situation
- Subjects from spanish speaking countries in situation of "Local transmission" by COVID19
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyOnline survey completion through google app. | Other | – |
Primary outcome
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
Time frame: 8-15 weeks
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)
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
Time frame: 8-15 weeks
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)
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
Time frame: 8-15 weeks
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)
Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on depression health status through DASS-21
Time frame: 8-15 weeks
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)
IImpact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on anxiety health status through DASS-21
Time frame: 8-15 weeks
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)
Impact of International Physical Activity Questionnaire-score (high, moderate, low level;higher scores mean a better outcome) on stress health status through DASS-21
Time frame: 8-15 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 24898865Zhang 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.
- Background: PubMed 32032543Xiang 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.
- Background: PubMed 32155789Wang 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.
- Background: PubMed 21123641Owen 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 32099716Chen 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.
- Derived from this study: PubMed 32527993Camacho-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alba Dr Camacho-Cardenosa, Doctor principal investigator
University of Extremadura
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Behavior and Mental Health Wellness 1, run by University of Extremadura at 3 sites in 3 countries.
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 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Chile, Uruguay. 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?
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 (time frame: 8-15 weeks). The study lists 6 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 NCT04352517, which also lists 7 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 21 Feb 2021.