NCT04818697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

March 24, 2021

Last Update Submit

October 1, 2024

Conditions

Keywords

Heart Rhythm DisorderPhysical ActivityKinesophobiaHealth Literacy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Health Literacy

    June 2020-March 2021

  • Weekly Average of Steps

    June 2020-March 2021

  • Weekly Average of Going Outside

    June 2020-March 2021

  • The Comorbid Conditions

    June 2020-March 2021

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Having been diagnosed with heart rhythm disorders
  • Being clinically stable
  • To comply with social isolation rules
  • Volunteering to participate in the research

You may not qualify if:

  • Having a cognitive problem
  • Not being literate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Social IsolationMotor ActivityKinesiophobia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Hikmet Yorgun, PhD MD

    Hacettepe University

    STUDY CHAIR
  • Ahmet Hakan Ates, PhD MD

    Hacettepe University

    STUDY CHAIR
  • Dilara Saklıca, MsC

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

June 24, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations