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Clinical Trials/NCT04407624
NCT04407624
Unknown
Not Applicable

Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Dokuz Eylul University1 site in 1 country34 target enrollmentOctober 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Infarction
Sponsor
Dokuz Eylul University
Enrollment
34
Locations
1
Primary Endpoint
Change in FVC
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2019
End Date
November 12, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elvan Keles

Research Assistant

Dokuz Eylul University

Eligibility 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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Change in body fat percentage(Baseline, 12th week)
  • Change in The Hospital Anxiety and Depression Scale(Baseline, 12th week)
  • Change in weight(Baseline, 12th week)
  • Change in severity of dyspnoea(Baseline, 12th week)
  • Change in The Fatigue Severity Scale(Baseline, 12th week)
  • Change in MacNew Heart Disease Health-Related Quality of Life instrument(Baseline, 12th week)
  • Change in body mass index(Baseline, 12th week)
  • Change in lean body mass(Baseline, 12th week)
  • Change in The International Physical Activity Questionnaire-short form(Baseline, 12th week)
  • Change in The Tampa Kinesiophobia Scale for Heart Patients(Baseline, 12th week)

Study Sites (1)

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