NCT03858829

Brief Summary

Low motivation to exercise is one of the barriers to participation in cardiac rehabilitation. Fear of activity after a cardiac event is associated with low levels of physical activity. This study aimed to develop and validate a scale to measure fear of activity in patients with coronary artery disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

February 27, 2019

Last Update Submit

February 28, 2019

Conditions

Keywords

coronary artery diseasephysical activitycardiac rehabilitationvalidation studiespsychometrics

Outcome Measures

Primary Outcomes (1)

  • A scale for fear of activity

    Each item is scored by a 5-point likert scale (4= always, 3= mostly, 2= sometimes, 1= seldom, 0= never). The scale is bi-directional; seven items 1, 5, 9, 13, 17, 19 and 21 are positively designed and their scores are inversely scored (0= always, 1= mostly, 2= sometimes, 3= seldom, 4= never). Total score is calculated by summing the scores of each item. Higher scores indicate the severity of fear of activity.

    baseline

Secondary Outcomes (3)

  • Nottingham Health Profile

    baseline

  • Beck Depression Inventory

    baseline

  • Beck Anxiety Inventory

    baseline

Study Arms (1)

fear of movement scale

EXPERIMENTAL
Other: Psychometric analysis

Interventions

Psychometric analysis

fear of movement scale

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has had myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within the last 12 months.

You may not qualify if:

  • Acute cardiac event within the last month
  • Attendance to cardiac rehabilitation
  • İnability to read and understand,
  • İnability to ambulate or unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ozyemisci-Taskiran O, Demirsoy N, Atan T, Yuksel S, Coskun O, Aytur YK, Tur BS, Karakas M, Turak O, Topal S. Development and Validation of a Scale to Measure Fear of Activity in Patients With Coronary Artery Disease (Fact-CAD). Arch Phys Med Rehabil. 2020 Mar;101(3):479-486. doi: 10.1016/j.apmr.2019.09.001. Epub 2019 Sep 25.

MeSH Terms

Conditions

Coronary Artery DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 1, 2019

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

March 4, 2019

Record last verified: 2019-02