Evaluation of Cognitive Status, Kinesiophobia, Physical A... | NCT05553106

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

NCT05553106

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Oct 21, 2022Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Heart Diseases

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2022Actual

Primary Completion Date

Nov 2022Estimated

Completion Date

Nov 2022Estimated

First Submitted Date

Sep 19, 2022

First Submission Date that Met QC Criteria

Sep 21, 2022

First Posted Date

Sep 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2022

Last Update Posted Date

Oct 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Symptom Assessment	Cardiac symptom survey will be used.	2 weeks
Cognitive Status Assessment	The Montreal Cognitive Assessment (MoCA) will be used

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Naciye Vardar-Yagli, PhD	Hacettepe University	Study Director
Hikmet Yorgun, PhD	Hacettepe University	Study Director
Ahmet Hakan Ates, PhD	Hacettepe University	Study Chair
Dilara Saklica, MSc	Hacettepe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D003324	Coronary Artery Disease
D000092442	Kinesiophobia

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided