- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407624
Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elvan Keleş, PT, MSc
- Phone Number: 0902323293535
- Email: elvan_keles@yahoo.com
Study Contact Backup
- Name: Hazal Yakut, PT, MSc
- Email: fzthazalyakut@outlook.com
Study Locations
-
-
-
İzmir, Turkey, 35340
- Recruiting
- Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
-
Contact:
- Elvan Keleş, PT, MSc
- Phone Number: 00902323293535
- Email: 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
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12th week
|
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. |
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: Baseline, 12th week
|
Tanita Body Composition Analyzer determines body weight as kilograms (kg).
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
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.
|
Baseline, 12th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4923-GOA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on Intermittent Exercise
-
National Taiwan University HospitalCompletedSystematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous ShuntTaiwan
-
Centre Hospitalier Universitaire de BesanconTerminatedArthritis, RheumatoidFrance
-
Universidade Federal de PernambucoCompleted
-
European University Miguel de CervantesHospital Clínico Universitario de ValladolidCompletedPeripheral Arterial Disease | Intermittent ClaudicationSpain
-
Karolinska InstitutetKarolinska University HospitalRecruitingDiabetes Mellitus, Type 2 | Circadian Rhythm | Glycemic ControlSweden
-
University of SunderlandSheffield Hallam University; Newcastle University; Teesside UniversitySuspendedQt Interval, Variation inUnited Kingdom
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingFabry Disease | Fabry Disease, Cardiac VariantNetherlands
-
University of ManitobaUnknownSpinal Cord Injuries | Spinal Cord Injury Cervical | Paraplegia, Spinal
-
Flinders UniversityThe Queen Elizabeth Hospital; Flinders Medical Centre; Royal Adelaide HospitalCompletedPeripheral Arterial DiseaseAustralia
-
Peking University Third HospitalRecruitingObesity | Metabolic SyndromeChina