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临床试验/NCT04772404
NCT04772404Unknown不适用

Repercussion of the COVID-19 Pandemic on Physical Activity, Psychological State and Sleep

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Knowledge of COVID

研究概览

简要总结

The COVID-19 outbreak in our environment has caused significant changes in the population. The main objective of this research project is to evaluate the level of physical activity, psychological state and sleep during the COVID-19 pandemic in different populations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Healthy people

排除标准

  • Cognitive impairment.
  • Diagnose of autism spectrum disorder or severe intellectual disability
  • Physical or functional impairment that limits the performance of evaluation

结局指标

主要结局

Knowledge of COVID

时间窗: Baseline

Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.

COVID-19 Anxiety Scale (CAS)

时间窗: Baseline

Coronavirus anxiety scale (CAS): It is a scale that measures the anxiety generated by COVID-19 in the last two weeks. It presents 5 items and a score\> 9 indicates dysfunctional anxiety associated with the pandemic.

International physical activity questionnaire

时间窗: Baseline

The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. Higher scores indicates higher physical activity levels.

Connor-Davidson Resilience Scale

时间窗: Baseline

Connor-Davidson Resilience Scale (CD-RISC) was used to measure resilience. It consists of 10 items which form five factors. Respondents are asked to answer on a five-point Likert scale (0 = totally disagree to 4 = totally agree).

Questionnaire of the transtheoretical model of change of physical exercise

时间窗: Baseline

Questionnaire of the transtheoretical model of change of physical exercise (QTMCPE): It is made up of 22 items for people who are not physically active and 9 items for physically active people. It is a Likert-type scale that measures from 1 to 5.

Fear of COVID-19 Scale

时间窗: Baseline

Bangla fear of COVID (FCV19-S): It is a questionnaire that assesses the fear of COVID-19. It consists of 7 items scored on a 5-item Likert scale. The higher the score, the more fear.

Steps per day

时间窗: Baseline

Accelerometer

Hospital Anxiety and Depression Scale

时间窗: Baseline

Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS) . This scale is composed of 14 items divided into two subscales, 7 items of anxiety and 7 items of depression, involving higher values worse psycho-emotional state.

COVID Stress Scales

时间窗: Baseline

COVID stress scale (CSS): is a 36-item COVID Stress Scale (CSS) to measure these features, as they pertain to COVID-19. The CSS were developed to better understand and assess COVID-19-related distress. The scales were intentionally designed so they could be readily adapted for future pandemics.

Barriers to being active quiz

时间窗: Baseline

Barriers to being active quiz (BBAQ-21): It is a questionnaire that consists of 21 items. This questionnaire was aimed at ascertaining perception of barriers against engaging in PA.

Burn-Out de Maslach Inventory

时间窗: Baseline

The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout

COPE-28

时间窗: Baseline

The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences.

Pittsburgh Sleep Quality Index

时间窗: Baseline

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances in the previous month.

Morningness-eveningness questionnaire (MEQ)

时间窗: Baseline

Morningness-Eveningness Questionnaire: Consisting of 19 items, the scale was developed to assess individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day. Scale items query preferences in sleep and waking times, and subjective "peak" times at which respondents feel their best.

Epworth sleepiness Scale

时间窗: Baseline

The ESS asks the respondent to rate on a 4-point scale (0-3) their usual chances of having dozed off or fallen asleep while engaged in eight different activities that differ widely in their somnificity.

Insomnia severity index

时间窗: Baseline

Insomnia severity index: It consists of 24 questions that measure sleep disturbances along dimensions: subjective sleep quality, sleep latency (LS), duration, efficiency, sleep disorders, use of sleep medication, and daytime dysfunction. The evaluation is based on the answers obtained from the previous month.

次要结局

  • Charlson Comorbidity Index(Baseline)
  • EuroQoL-5D(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

研究点 (1)

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