- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04818697
Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic
Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
Study Overview
Status
Conditions
Detailed Description
To prevent the spread of COVID-19, states are imposing quarantine measures and sanctions for all citizens to stay at home as much as possible. These measures severely limit physical activity. It is known that physical activity is an important preventive approach for many preventable diseases, especially cardiovascular diseases. Restriction of physical activity, loss of usual routine, and reduced social and physical contact with others can cause feelings of distress, disappointment, and isolation.
In the latest guidelines, increasing physical activity is recommended to prevent heart rhythm disorders and contribute to the effectiveness of treatment.
The aim of our study is to examine the effect of social isolation on physical activity level, health literacy, and kinesophobia in heart rhythm disorders.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having been diagnosed with heart rhythm disorders
- Being clinically stable
- To comply with social isolation rules
- Volunteering to participate in the research
Exclusion Criteria:
- Having a cognitive problem
- Not being literate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy individuals
Healthy individuals without chronic disease
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Patients with heart rhythm disorders
Having been diagnosed with heart rhythm disorders such as atrial fibrillation, atrial tachycardia, ventricular tachycardia, and ventricular extrasystole
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Level
Time Frame: June 2020-March 2021
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Physical activity level will be evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
The questionnaire provides information about the time spent on walking and moderate-to-severe / vigorous activities, while also evaluating the time spent sitting (sedentary behavior level).
Physical activity levels are classified according to MET-min/week values.
According to these values, people are classified as physically inactive (inactive), low level of physical activity (minimally active), and sufficient level of physical activity (very active).
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June 2020-March 2021
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Fear of Movement
Time Frame: June 2020-March 2021
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Fear of movement will be evaluated using the Tampa Scale of Kinesiophobia for Heart.
The scale consists of 17 items.
The score a participant can get is between 17 and 68.
The higher the total score, the higher the severity of kinesiophobia.
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June 2020-March 2021
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Literacy
Time Frame: June 2020-March 2021
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Health literacy will be evaluated using the Health Literacy Scale.
This questionnaire consists of 25 questions and four sub-dimensions.
A minimum of 25 and a maximum of 125 points are obtained for the entire scale.
The higher the score obtained from the questionnaire, the higher the health literacy level of the participant.
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June 2020-March 2021
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Weekly Average of Steps
Time Frame: June 2020-March 2021
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The number of steps in the last week will be recorded and averaged using the pedometer applications from the participants own smartphones.
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June 2020-March 2021
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Weekly Average of Going Outside
Time Frame: June 2020-March 2021
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The number of days spent outside last week will be recorded.
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June 2020-March 2021
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The Comorbid Conditions
Time Frame: June 2020-March 2021
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The comorbid conditions of the patients will be evaluated by Charlson's comorbidity index.
As the score obtained from the index increases, the comorbid situation increases.
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June 2020-March 2021
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hikmet Yorgun, PhD MD, Hacettepe University
- Study Chair: Ahmet Hakan Ates, PhD MD, Hacettepe University
- Principal Investigator: Dilara Saklıca, MsC, Hacettepe University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Disease
- Arrhythmias, Cardiac
Other Study ID Numbers
- GO 20/633
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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