Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2019
CompletedFirst Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedMay 29, 2020
May 1, 2020
8 months
January 27, 2020
May 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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 Outcomes (10)
Change in weight
Baseline, 12th week
Change in body mass index
Baseline, 12th week
Change in body fat percentage
Baseline, 12th week
Change in lean body mass
Baseline, 12th week
Change in severity of dyspnoea
Baseline, 12th week
- +5 more secondary outcomes
Study Arms (2)
Intermittent Exercise Group
EXPERIMENTALWarm-up, loading (walking, squat, sitting down on a chair, limb movements with weights, stepping on steps, walking on different floors), cooling and relaxation exercises
Control Group
ACTIVE COMPARATORWarm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Having had MI at least 3 months ago
- Stable clinical status for at least two weeks
- Walking independently
- Volunteer for research study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
Izmir, 35340, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 34993836DERIVEDDibben 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.
PMID: 34741536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
January 27, 2020
First Posted
May 29, 2020
Study Start
October 9, 2019
Primary Completion
June 10, 2020
Study Completion
November 12, 2020
Last Updated
May 29, 2020
Record last verified: 2020-05