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

NCT04335760 | Completed

• 1 other identifier: 25901600/7587, 27.11.2013
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Fear of activity scale in CAD (FactCAD)

  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.

  baseline

• Functional capacity (6MWT)

  Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response.

  baseline

• Exercise test (Modified Bruce protocol)

  Modified Bruce protocol on treadmill was used in institutions where technical equipment and experience was available.

  baseline

Study Arms (2)

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.

Combination Product: Modified Bruce protocol on treadmill

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.

Combination Product: Modified Bruce protocol on treadmill

Interventions

Modified Bruce protocol on treadmill 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.

Patients with Coronary Artery Disease; healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tuğba Atan: lead

Study Sites (1)

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

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Links

• A Multi-Center Study From Turkey

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Physiatrist (Department of Physical Medicine and Rehabilitation)

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)