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

NCT04772404 | Unknown

• 1 other identifier: DF0094UG
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• Burn-Out de Maslach Inventory

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

  Baseline

• Steps per day

  Accelerometer

  Baseline

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• EuroQoL-5D

  Baseline

• Charlson Comorbidity Index

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy people

You may qualify if:

• Healthy people

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Department of Physical Therapy

Granada, 18016, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; PT; PhD

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 26, 2021
• Study Start: March 7, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 15, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)