Clinical trial NCT04407624: Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
Official title: Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: Aerobic exercise
Intermittent exercise
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in functional capacity
timeFrame: Baseline, 12th week
measure: Change in peripheral muscle strength
timeFrame: Baseline, 12th week
measure: Change in respiratory muscle strength
timeFrame: Baseline, 12th week
measure: Change in FEV1
timeFrame: Baseline, 12th week
measure: Change in FVC
timeFrame: Baseline, 12th week
measure: Change in FEV1/FVC
timeFrame: Baseline, 12th week
measure: Change in PEF
timeFrame: Baseline, 12th week
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 12th week
measure: Change in body mass index
timeFrame: Baseline, 12th week
measure: Change in body fat percentage
timeFrame: Baseline, 12th week
measure: Change in lean body mass
timeFrame: Baseline, 12th week
measure: Change in severity of dyspnoea
timeFrame: Baseline, 12th week
measure: Change in The Tampa Kinesiophobia Scale for Heart Patients
timeFrame: Baseline, 12th week
measure: Change in The International Physical Activity Questionnaire-short form
timeFrame: Baseline, 12th week
measure: Change in The Fatigue Severity Scale
timeFrame: Baseline, 12th week
measure: Change in The Hospital Anxiety and Depression Scale
timeFrame: Baseline, 12th week
measure: Change in MacNew Heart Disease Health-Related Quality of Life instrument
timeFrame: Baseline, 12th week
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
Study officials:
References:
citation: Yakut H, Dursun H, Felekoglu E, Baskurt AA, Alpaydin AO, Ozalevli S. Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. Ir J Med Sci. 2022 Dec;191(6):2539-2548. doi: 10.1007/s11845-021-02867-x. Epub 2022 Jan 7.
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.