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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04818697
Other study ID # GO 20/633
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 24, 2020
Est. completion date March 19, 2021

Study information

Verified date March 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date March 19, 2021
Est. primary completion date March 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Level 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). June 2020-March 2021
Primary Fear of Movement 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. June 2020-March 2021
Secondary Health Literacy 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. June 2020-March 2021
Secondary Weekly Average of Steps The number of steps in the last week will be recorded and averaged using the pedometer applications from the participants own smartphones. June 2020-March 2021
Secondary Weekly Average of Going Outside The number of days spent outside last week will be recorded. June 2020-March 2021
Secondary The Comorbid Conditions 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. June 2020-March 2021
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