Coronary Artery DiseaseNCT04335760
Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Tuğba Atan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Modified Bruce protocol on treadmill
- How many people
- 309 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population consisted of 196 patients with CAD (144 men, 52 women) and 113 healthy subjects (73 men, 40 women).
Who may be able to join
- 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.
Who cannot join
- Patients with recent cardiac event sooner than 1 month
- Musculoskeletal/neurologic problems imparing ambulation or current hospitalization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital
Ankara, Çankaya, 06800
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Modified Bruce protocol on treadmill
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Bruce protocol on treadmillCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Modified Bruce protocol on treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Exercise test (Modified Bruce protocol)
Modified Bruce protocol on treadmill was used in institutions where technical equipment and experience was available.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Atan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Atan, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335760
- Sponsor's protocol ID
- 25901600/7587, 27.11.2013
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04335760
- Acronym / sponsor ID
- 25901600/7587, 27.11.2013
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Tuğba AtanUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Coronary Artery Disease | – | Combination Product: Modified Bruce protocol on treadmillFear 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 | – | Combination Product: Modified Bruce protocol on treadmillFear 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consisted of 196 patients with CAD (144 men, 52 women) and 113 healthy subjects (73 men, 40 women).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with recent cardiac event sooner than 1 month
- Musculoskeletal/neurologic problems imparing ambulation or current hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Bruce protocol on treadmillFear 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 | Patients with Coronary Artery Disease, healthy subjects |
Primary outcome
Fear of activity scale in CAD (FactCAD)
Time frame: baseline
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 (6MWT)
Time frame: baseline
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.
Exercise test (Modified Bruce protocol)
Time frame: baseline
Modified Bruce protocol on treadmill was used in institutions where technical equipment and experience was available.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- A Multi-Center Study From TurkeyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Tuğba Atan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of activity scale in CAD (FactCAD) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.