Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407624
• Other study ID #: 4923-GOA
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: November 12, 2020

Study information

• Verified date: May 2020
• Source: Dokuz Eylul University
• Contact: Elvan Keles, PT, MSc
• Phone: 0902323293535
• Email: elvan_keles[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 12, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional capacity	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.	Baseline, 12th week
Primary	Change in peripheral muscle strength	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.	Baseline, 12th week
Primary	Change in respiratory muscle strength	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.	Baseline, 12th week
Primary	Change in FEV1	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.	Baseline, 12th week
Primary	Change in FVC	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.	Baseline, 12th week
Primary	Change in FEV1/FVC	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.	Baseline, 12th week
Primary	Change in PEF	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.	Baseline, 12th week
Secondary	Change in weight	Tanita Body Composition Analyzer determines body weight as kilograms (kg).	Baseline, 12th week
Secondary	Change in body mass index	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.	Baseline, 12th week
Secondary	Change in body fat percentage	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.	Baseline, 12th week
Secondary	Change in lean body mass	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.	Baseline, 12th week
Secondary	Change in severity of dyspnoea	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.	Baseline, 12th week
Secondary	Change in The Tampa Kinesiophobia Scale for Heart Patients	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.	Baseline, 12th week
Secondary	Change in The International Physical Activity Questionnaire-short form	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.	Baseline, 12th week
Secondary	Change in The Fatigue Severity Scale	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.	Baseline, 12th week
Secondary	Change in The Hospital Anxiety and Depression Scale	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.	Baseline, 12th week
Secondary	Change in MacNew Heart Disease Health-Related Quality of Life instrument	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.	Baseline, 12th week