NCT05553106

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

September 19, 2022

Last Update Submit

October 20, 2022

Conditions

Heart Diseases

Keywords

intensive carecoronary artery diseasekinesiophobiaphysical activity level

Outcome Measures

Primary Outcomes (1)

  • Functional Performance Assessment

    Functional status score for the intensive care unit (FSS-ICU) will be used.

    2 weeks

Secondary Outcomes (4)

  • Symptom Assessment

    2 weeks

  • Cognitive Status Assessment

    2 weeks

  • Physical Activity Level

    2 weeks

  • Fear of Movement

    2 weeks

Study Arms (1)

Study Group

Patients who are hospitalized in the coronary intensive care unit, who can take simple commands, and whose condition is physiologically stable.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart DiseasesCoronary Artery DiseaseKinesiophobia

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • 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

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

September 19, 2022

First Posted

September 23, 2022

Study Start

September 23, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations

TU(1)