- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048057
The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Kutahya, Center, Turkey, 43100
- Kütahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery,
- Nonobstructive CAD registered by angiography
- Left ventricular ejection fraction above 50%,
- Clinically stable for more than 2 weeks in terms of symptoms and medical treatment.
Exclusion Criteria:
- Ischemia symptoms,
- Being in Class III-IV according to the New York Heart Classification,
- Obtaining significant left ventricular outflow obstruction,
- Ventricular arrhythmia,
- Being marked valvular heart disease,
- Failure to comply with exercise testing and training rules,
- To have significant orthopedic or neurological comorbidity that prevents full participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modarete Intensity Continous Training
|
Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power. High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. |
|
Experimental: High Intensity Interval Training I
|
Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power. High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. |
|
Experimental: High Intensity Interval Training II
|
Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power. High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
exercise capacity
Time Frame: 15 minutes
|
Cardiopulmonary exercise test
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MacNew Health Related Quallity of Life Qustionnaire
Time Frame: 15 minutes
|
The validity and reliability of the MacNew Heart Disease Health-Related Quality of Life Questionnaire Daşkapan et al. in 2008.
It is a scale developed to determine the quality of life in heart diseases consisting of 27 items each containing a 7-point Likert type response.
In the evaluation of the scale, 3 sub-dimensions (emotional, physical and social) and total score values are used
|
15 minutes
|
|
body composition
Time Frame: 1 minute
|
Tanita
|
1 minute
|
|
physical activity level
Time Frame: 15 minutes
|
International Physical Activity Questionnaire
|
15 minutes
|
|
fear of movement
Time Frame: 15 minutes
|
Tampa
|
15 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KMSU-Exercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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