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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772404
• Other study ID #: DF0094UG
• Status: Recruiting
• Start date: March 7, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: March 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of COVID	Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.	Baseline
Primary	Fear of COVID-19 Scale	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.	Baseline
Primary	COVID-19 Anxiety Scale (CAS)	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.	Baseline
Primary	COVID Stress Scales	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.	Baseline
Primary	Burn-Out de Maslach Inventory	The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout	Baseline
Primary	Steps per day	Accelerometer	Baseline
Primary	International physical activity questionnaire	The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. Higher scores indicates higher physical activity levels.	Baseline
Primary	Barriers to being active quiz	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.	Baseline
Primary	Questionnaire of the transtheoretical model of change of physical exercise	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.	Baseline
Primary	Hospital Anxiety and Depression Scale	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.	Baseline
Primary	Connor-Davidson Resilience Scale	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).	Baseline
Primary	COPE-28	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.	Baseline
Primary	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances in the previous month.	Baseline
Primary	Morningness-eveningness questionnaire (MEQ)	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.	Baseline
Primary	Epworth sleepiness Scale	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.	Baseline
Primary	Insomnia severity index	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.	Baseline
Secondary	EuroQoL-5D	The perception of the level of health and the quality of life were evaluated with the questionnaire European Quality of; Life-5 Dimensions (EQ-5D). It is composed of 2 parts in which health status is assessed: Descriptive system: It consists on 5 dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients classify their health status in 3 severity levels: having no problems, having some or moderate problems, being unable to do/having extreme problems.; Visual Analog Scale, by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)	Baseline
Secondary	Charlson Comorbidity Index	Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions	Baseline