跳至主要内容
临床试验/NCT04352517
NCT04352517已完成不适用

Influence of Physical Activity on Psychological Responses During Coronavirus Disease (COVID-19) Pandemic: a Multi-center and Observational Study

University of Extremadura3 个研究点 分布在 3 个国家目标入组 3,500 人开始时间: 2020年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,500
试验地点
3
主要终点
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

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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 avoidance impact of COVID-19 through IES-R

时间窗: 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)

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

时间窗: 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 hyperarousal impact of COVID-19 through IES-R

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alba Camacho-Cardenosa

Principal Investigator

University of Extremadura

研究点 (3)

Loading locations...

相似试验