Clinical trial NCT04335760: Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease
Official title: Is There a Relationship Between Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease? - A Multi-Center Study From Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consisted of 196 patients with CAD (144 men, 52 women) and 113 healthy subjects (73 men, 40 women).

Brief summary: To identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients.

Detailed description: Cardiac rehabilitation (CR) is a well-known way of secondary prevention in heart diseases. CR is shown to be effective in reducing cardiovascular morbidity and mortality. CR also enhances exercise capacity and quality of life, promotes healthy and active lifestyle and reduces psychosocial stress and depressive symptoms in coronary artery disease (CAD). Exercise is one of the most important component of CR. The positive prognostic effect of the exercise on cardiovascular disease is mediated by mechanisms such as reducing numerous risk factors, enhancing endothelial function, declining arterial inflammation and stiffness, improving diastolic function, remodeling of left ventricle, and stabilization of electrical activity. Each 1 MET increase in functional capacity is known to improve survival by 12 %. Exercise capacity is a more powerful predictor of mortality among men than other established risk factors for cardiovascular disease.

The prevalence of fear of activity in CAD, heart failure and female patients have been studied by several researchers reporting variable results. It ranges from 70% in acute hospitalized CAD patients to 20% in chronic patients in community. Muscle endurance, steps per day measured by pedometer, IPAQ were found to be lower in patients with high level of fear of activity.They did not measure exercise capacity objectively. Research investigating the effect of fear of activity on exercise capacity in patients with CAD is lacking.

The aim of this study is to identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients. The hypothesis of this study were that CAD patients would have lower exercise capacity than healthy subjects and CAD patients with higher fear of activity would have lower exercise capacity.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* History of diagnosis of CAD and/or cardiac event in the past 1-60 months
* Being medically stable
* Cognitive and physical ability to complete the required tests.

Exclusion Criteria:

* Patients with recent cardiac event sooner than 1 month
* Musculoskeletal/neurologic problems imparing ambulation or current hospitalization

Primary outcomes:
measure: Fear of activity scale in CAD (FactCAD)
timeFrame: baseline
measure: Functional capacity (6MWT)
timeFrame: baseline
measure: Exercise test (Modified Bruce protocol)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital
state: Çankaya
Study officials:
References: