Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic

• ClinicalTrials.gov Identifier: NCT04818697
• Recruitment Status: Completed
• First Posted: March 26, 2021
• Last Update Posted: March 30, 2021
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Dilara Saklica, Hacettepe University

Study Description

Brief 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.

Condition or disease
Heart Rhythm Disorder; Covid19; Social Isolation

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 Design

• Study Type: Observational
• Actual Enrollment: 105 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
• Actual Study Start Date: June 24, 2020
• Actual Primary Completion Date: March 19, 2021
• Actual Study Completion Date: March 19, 2021

Groups and Cohorts

Group/Cohort
Patients with heart rhythm disorders; Having been diagnosed with heart rhythm disorders such as atrial fibrillation, atrial tachycardia, ventricular tachycardia, and ventricular extrasystole
Healthy individuals; Healthy individuals without chronic disease

Outcome Measures

Primary Outcome Measures :

1. Physical Activity Level [ Time Frame: June 2020-March 2021 ]
   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).
2. Fear of Movement [ Time Frame: June 2020-March 2021 ]
   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.

Secondary Outcome Measures :

1. Health Literacy [ Time Frame: June 2020-March 2021 ]
   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.
2. Weekly Average of Steps [ Time Frame: June 2020-March 2021 ]
   The number of steps in the last week will be recorded and averaged using the pedometer applications from the participants own smartphones.
3. Weekly Average of Going Outside [ Time Frame: June 2020-March 2021 ]
   The number of days spent outside last week will be recorded.
4. The Comorbid Conditions [ Time Frame: June 2020-March 2021 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients and healthy individuals 18 years old and older, who are diagnosed with heart rhythm disorders, and whose local language is Turkish will be included in the study.

Criteria

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

Contacts and Locations

Locations

Turkey

Hacettepe University

Ankara, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

Investigators

• Study Director: Naciye Vardar-Yagli, PhD; Hacettepe University
• Study Chair: Hikmet Yorgun, PhD MD; Hacettepe University
• Study Chair: Ahmet Hakan Ates, PhD MD; Hacettepe University
• Principal Investigator: Dilara Saklıca, MsC; Hacettepe University

More Information

• Responsible Party: Dilara Saklica, Principal Investigator, Hacettepe University
• ClinicalTrials.gov Identifier: NCT04818697
• Other Study ID Numbers: GO 20/633
• First Posted: March 26, 2021
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dilara Saklica, Hacettepe University:

Heart Rhythm Disorder; Physical Activity; Kinesophobia; Health Literacy

Additional relevant MeSH terms:

COVID-19; Arrhythmias, Cardiac; Disease; Pathologic Processes; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases