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Clinical Trials/NCT04772404
NCT04772404
Unknown
Not Applicable

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

Universidad de Granada1 site in 1 country100 target enrollmentMarch 7, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Universidad de Granada
Enrollment
100
Locations
1
Primary Endpoint
Knowledge of COVID
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2021
End Date
June 15, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Healthy people

Exclusion Criteria

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

Outcomes

Primary Outcomes

Knowledge of COVID

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline

Accelerometer

Hospital Anxiety and Depression Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline

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

COPE-28

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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