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Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407624
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Elvan Keles, Dokuz Eylul University

Brief Summary:

Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death.

Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia.

Patients with MI are candidates for cardiac rehabilitation (CR). American Heart Association (AHA) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. When the literature on patients with MI is examined, various exercise programs are seen. The aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with MI.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Intermittent Exercise Other: Control Not Applicable

Detailed Description:
Cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermittent Exercise Group
Warm-up, loading (walking, squat, sitting down on a chair, limb movements with weights, stepping on steps, walking on different floors), cooling and relaxation exercises
Other: Intermittent Exercise
Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Participants are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.

Active Comparator: Control Group
Warm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises
Other: Control
Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In loading period, moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Stretching exercises are done during the cooling period.




Primary Outcome Measures :
  1. Change in functional capacity [ Time Frame: Baseline, 12th week ]
    Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.

  2. Change in peripheral muscle strength [ Time Frame: Baseline, 12th week ]

    The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles.

    Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer.


  3. Change in respiratory muscle strength [ Time Frame: Baseline, 12th week ]
    Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter.

  4. Change in FEV1 [ Time Frame: Baseline, 12th week ]
    FEV1 is the maximal amount of air which is forcefully exhale in one second. It is then converted to a percentage of normal predicted based on height, weight, and race.

  5. Change in FVC [ Time Frame: Baseline, 12th week ]
    Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from lungs after taking the deepest breath possible, as measured by spirometry.

  6. Change in FEV1/FVC [ Time Frame: Baseline, 12th week ]
    Also known as Tiffeneau-Pinelli index, FEV1/FVC ratio is often used in diagnosing and treating lung diseases. The FEV1/FVC ratio is a measurement of the amount of air you can forcefully exhale from your lungs.

  7. Change in PEF [ Time Frame: Baseline, 12th week ]
    Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second.


Secondary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline, 12th week ]
    Tanita Body Composition Analyzer determines body weight as kilograms (kg).

  2. Change in body mass index [ Time Frame: Baseline, 12th week ]
    Tanita Body Composition Analyzer determines Body Mass Index (BMI) which is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

  3. Change in body fat percentage [ Time Frame: Baseline, 12th week ]
    Tanita Body Composition Analyzer determines the body fat percentage (BFP) which is the total mass of fat divided by total body mass, multiplied by 100.

  4. Change in lean body mass [ Time Frame: Baseline, 12th week ]
    Tanita Body Composition Analyzer determines Lean Body Mass (LBM) also known as "Fat-Free Mass" which is the total weight of body minus all the weight due to your fat mass. LBM includes the weight of organs, skin, bones, body water and muscle mass.

  5. Change in severity of dyspnoea [ Time Frame: Baseline, 12th week ]
    Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea. This scale ranges from 0 to 4. A higher value represents a worse outcome.

  6. Change in The Tampa Kinesiophobia Scale for Heart Patients [ Time Frame: Baseline, 12th week ]
    The Tampa Kinesiophobia Scale for Heart Patients is a questionnaire consisting of 17 questions evaluating the fear of movement in heart patients. The minimum value is 17 and the maximum value is 68, and the higher score means a worse outcome.

  7. Change in The International Physical Activity Questionnaire-short form [ Time Frame: Baseline, 12th week ]
    The International Physical Activity Questionnaire-short form (IPAQ-SF) consists of 7 questions and gives information about the time spent on walking, moderate-to-severe, severe activities. A score in MET-minutes is obtained. The minimum value is 0 and the higher score means a better outcome.

  8. Change in The Fatigue Severity Scale [ Time Frame: Baseline, 12th week ]
    The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The minimum value is 9 and the maximum value is 63. The higher score means greater fatigue severity.

  9. Change in The Hospital Anxiety and Depression Scale [ Time Frame: Baseline, 12th week ]
    The Hospital Anxiety and Depression Scale (HADS) assesses both anxiety and depression, which commonly coexist. It comprises seven questions for anxiety and seven questions for depression, and takes 2-5 min to complete. The minimum value is 0, the maximum value is 21 and the higher score means a worse outcome.

  10. Change in MacNew Heart Disease Health-Related Quality of Life instrument [ Time Frame: Baseline, 12th week ]
    The MacNew Heart Disease Health-related Quality of Life (HRQL) instrument is designed to assess patient's feelings about how ischemic heart disease affects daily functioning and contains 27 items with a global HRQL score and physical limitation and emotional, and social function subscales with a 2-week timeframe. The maximum possible score in any domain is 7 and the minimum is 1. The higher score means a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having had MI at least 3 months ago
  • Stable clinical status for at least two weeks
  • Walking independently
  • Volunteer for research study

Exclusion Criteria:

  • Having unstable angina
  • Having uncontrolled hypertension
  • Having hemodynamic instability
  • Participating in any exercise program in the last six months
  • Having a major orthopedic or neurological problem that limits functionality

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): NCT04407624


Contacts
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Contact: Elvan Keleş, PT, MSc 0902323293535 elvan_keles@yahoo.com
Contact: Hazal Yakut, PT, MSc fzthazalyakut@outlook.com

Locations
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Turkey
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation Recruiting
İzmir, Turkey, 35340
Contact: Elvan Keleş, PT, MSc    00902323293535    elvan_keles@yahoo.com   
Principal Investigator: Hazal Yakut, PT, MSc         
Sub-Investigator: Sevgi Özalevli, PT, PhD         
Sub-Investigator: Ahmet Anıl Başkurt, MD         
Sub-Investigator: Hüseyin Dursun, MD         
Sub-Investigator: Aylin Özgen Alpaydın, MD         
Sponsors and Collaborators
Dokuz Eylul University
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Responsible Party: Elvan Keles, Research Assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04407624    
Other Study ID Numbers: 4923-GOA
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elvan Keles, Dokuz Eylul University:
Aerobic exercise
Intermittent exercise
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases