Heart Rhythm DisorderNCT04818697
Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic
An observational study of Heart Rhythm Disorder and Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rhythm Disorder, Covid19, Social Isolation
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2020to 19 Mar 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Having been diagnosed with heart rhythm disorders
- Being clinically stable
- To comply with social isolation rules
- Volunteering to participate in the research
Who cannot join
- Having a cognitive problem
- Not being literate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- Heart Rhythm Disorder, Covid19, Social Isolation
- Keywords
- Heart Rhythm Disorder, Physical Activity, Kinesophobia, Health Literacy
- Medical subject headings
- COVID-19, Social Isolation, Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: June 2020-March 2021
Secondary outcomes (4)
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.
Measured: June 2020-March 2021
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.
Measured: June 2020-March 2021
Weekly Average of Going Outside
The number of days spent outside last week will be recorded.
Measured: June 2020-March 2021
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.
Measured: June 2020-March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start24 Jun 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rhythm DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Saklica, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityHikmet Yorgun, PhD MD, Study chair, Hacettepe UniversityAhmet Hakan Ates, PhD MD, Study chair, Hacettepe UniversityDilara Saklıca, MsC, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818697
- Sponsor's protocol ID
- GO 20/633
- Status last verified
- Oct 2024
- First submitted
- 24 Mar 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04818697
- Acronym / sponsor ID
- GO 20/633
- Conditions
- Heart Rhythm Disorder, Covid19, Social Isolation
- Keywords
- Heart Rhythm Disorder, Physical Activity, Kinesophobia, Health Literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Having been diagnosed with heart rhythm disorders
- Being clinically stable
- To comply with social isolation rules
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- Having a cognitive problem
- Not being literate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
4 secondary outcomes
Health Literacy
Time frame: June 2020-March 2021
Weekly Average of Steps
Time frame: June 2020-March 2021
Weekly Average of Going Outside
Time frame: June 2020-March 2021
The Comorbid Conditions
Time frame: June 2020-March 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Hikmet Yorgun, PhD MD study chair
Hacettepe University
Ahmet Hakan Ates, PhD MD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rhythm Disorder and Covid19, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: June 2020-March 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.