Covid19 Clinical Trial
Official title:
Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
| 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 |
| Verified date | March 2021 |
| Source | Hacettepe University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Hacettepe University | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Hacettepe University |
Turkey,
| 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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