Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease

NCT ID: NCT04335760

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Coronary Artery Disease

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.

Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available.

Modified Bruce protocol on treadmill

Intervention Type COMBINATION_PRODUCT

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.

Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available.

healthy subjects

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.

Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available.

Modified Bruce protocol on treadmill

Intervention Type COMBINATION_PRODUCT

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.

Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available.

Interventions

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Modified Bruce protocol on treadmill

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.

Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tuğba Atan

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Atan

MD, Physiatrist (Department of Physical Medicine and Rehabilitation)

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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25901600/7587, 27.11.2013

Identifier Type: -

Identifier Source: org_study_id

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