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The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04048057
Recruitment Status : Suspended (Because of Covid-19 pandemia, The cardiac rehabilitation unit in the hospital conducting the study has been closed for a while.)
First Posted : August 7, 2019
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ismail Okur, Kutahya Medical Sciences University

Brief Summary:
There are studies showing the superiority of HIIT protocols in patients with CAD in the literature, however there is no consensus on the use of HIIT protocols in CAD patients. In addition, in these studies, the HIIT protocols differ in severity and duration and there is no optimal HIIT protocol. Therefore, this study was planed to investigate of two different HIIT protocols and one MICT protocols, which are more commonly used in patients with CAD in the literature on exercise capacity, quality of life, body composition, physical activity level and fear of movement.

Condition or disease Intervention/treatment Phase
Exercise Cardiac Rehabilitation Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modarete Intensity Continous Training Other: Exercise

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 Other: Exercise

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 Other: Exercise

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.





Primary Outcome Measures :
  1. exercise capacity [ Time Frame: 15 minutes ]
    Cardiopulmonary exercise test


Secondary Outcome Measures :
  1. 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

  2. body composition [ Time Frame: 1 minute ]
    Tanita

  3. physical activity level [ Time Frame: 15 minutes ]
    International Physical Activity Questionnaire

  4. fear of movement [ Time Frame: 15 minutes ]
    Tampa



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048057


Locations
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Turkey
Kutahya Health Sciences University
Kutahya, Center, Turkey, 43100
Sponsors and Collaborators
Kutahya Medical Sciences University
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Responsible Party: Ismail Okur, Kutahya Medical Sciences University
ClinicalTrials.gov Identifier: NCT04048057    
Other Study ID Numbers: KMSU-Exercise
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No