Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care

An observational study of Heart Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Heart Diseases
How many people: 10 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 23 Sep 2022to Nov 2022
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients in coronary intensive care unit who can take simple commands and whose condition is physiologically stable

Who may be able to join

Volunteering to participate in the research
Being under surveillance in the coronary intensive care unit

Who cannot join

Presence of neurological disease that may affect the cognitive status
Not being clinically stable
Not to cooperate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hacettepe University
Ankara

Other trials in Turkey (Türkiye)

About this study

The aim of our study is to evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

Read the detailed description

This study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Conditions: Heart Diseases
Keywords: intensive care, coronary artery disease, kinesiophobia, physical activity level
Medical subject headings: Heart Diseases, Coronary Artery Disease, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05553106
Study group	Role	What they receive
Study Group		Patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Performance Assessment
Functional status score for the intensive care unit (FSS-ICU) will be used.
Measured: 2 weeks

Secondary outcomes (4)

Symptom Assessment
Cardiac symptom survey will be used.
Measured: 2 weeks
Cognitive Status Assessment
The Montreal Cognitive Assessment (MoCA) will be used
Measured: 2 weeks
Physical Activity Level
Physical activity level will be evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Measured: 2 weeks
Fear of Movement
Fear of movement will be evaluated using the Fear of Activity in Patients with Coronary Artery Disease (Fact-CAD).
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 2022Nov 2022

First posted23 Sep 2022
Study start23 Sep 2022
Primary completionNov 2022 (estimated)
Study completionNov 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart DiseasesStudies 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: 10 participants (estimated)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT05553106
Sponsor's protocol ID: GO 20/299
Status last verified: Oct 2022
First submitted: 19 Sep 2022
Last updated: 21 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Heart Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
ClinicalTrials.gov ID: NCT05553106
Acronym / sponsor ID: GO 20/299
Conditions: Heart Diseases
Keywords: intensive care, coronary artery disease, kinesiophobia, physical activity level
Study type: Observational
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Study start: 23 Sep 2022 (actual)
Primary completion: Nov 2022 (estimated)
Study completion: Nov 2022 (estimated)
First posted: 23 Sep 2022 (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 evaluate cognitive status, kinesiophobia, physical activity level, and functional performance in coronary intensive care.

Detailed description

This study will be performed on patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 1 Day
Number of arms: 1

Arm	Type	Receives
Study Group	–	–Patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in coronary intensive care unit who can take simple commands and whose condition is physiologically stable

Key inclusion criteria (2 listed)

Volunteering to participate in the research
Being under surveillance in the coronary intensive care unit

Key exclusion criteria (3 listed)

Presence of neurological disease that may affect the cognitive status
Not being clinically stable
Not to cooperate

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

Functional Performance Assessment
Time frame: 2 weeks
Functional status score for the intensive care unit (FSS-ICU) will be used.

4 secondary outcomes

Symptom Assessment
Time frame: 2 weeks
Cognitive Status Assessment
Time frame: 2 weeks
Physical Activity Level
Time frame: 2 weeks
Fear of Movement
Time frame: 2 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.

Related trials for Heart Diseases

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

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 study director

Hacettepe University

Ahmet Hakan Ates, PhD 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 Diseases, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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?

Results are not available in the source record.

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?

Functional Performance Assessment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05553106.

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 21 Oct 2022.