HealthyNCT04772404
Repercussion of the COVID-19 Pandemic on Physical Activity, Psychological State and Sleep
An observational study of Healthy, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2021to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people
Who may be able to join
- Healthy people
Who cannot join
- Cognitive impairment.
- Diagnose of autism spectrum disorder or severe intellectual disability
- Physical or functional impairment that limits the performance of evaluation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of Physical Therapy
Granada, 18016
Marie Carmen Valenza, PhD, cvalenza@ugr.es
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Burn-Out de Maslach Inventory
The Maslach Burnout Inventory (MBI) is a psychological assessment instrument comprising 22 symptom items pertaining to occupational burnout
Measured: Baseline
Steps per day
Accelerometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
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)
Measured: Baseline
Charlson Comorbidity Index
Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start7 Mar 2021
- Primary completion15 May 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772404
- Sponsor's protocol ID
- DF0094UG
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repercussion of the COVID-19 Pandemic on Physical Activity, Psychological State and Sleep
- ClinicalTrials.gov ID
- NCT04772404
- Acronym / sponsor ID
- DF0094UG
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people
Key inclusion criteria (1 listed)
- Healthy people
Key exclusion criteria (3 listed)
- Cognitive impairment.
- Diagnose of autism spectrum disorder or severe intellectual disability
- Physical or functional impairment that limits the performance of evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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
Steps per day
Time frame: Baseline
Accelerometer
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.
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.
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.
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.
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).
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.
2 secondary outcomes
EuroQoL-5D
Time frame: Baseline
Charlson Comorbidity Index
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of COVID (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.