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Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intermittent Exercise
Control
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Aerobic exercise, Intermittent exercise

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylül Üniversitesi School of Physical Therapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent Exercise Group

Control Group

Arm Description

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

Warm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Change in weight
Tanita Body Composition Analyzer determines body weight as kilograms (kg).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 27, 2020
Last Updated
May 25, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04407624
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
June 10, 2020 (Anticipated)
Study Completion Date
November 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Aerobic exercise, Intermittent exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent Exercise Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Warm-up, loading (brisk walking at 60-85% of maximum heart rate), cooling and relaxation exercises
Intervention Type
Other
Intervention Name(s)
Intermittent Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in functional capacity
Description
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.
Time Frame
Baseline, 12th week
Title
Change in peripheral muscle strength
Description
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.
Time Frame
Baseline, 12th week
Title
Change in respiratory muscle strength
Description
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.
Time Frame
Baseline, 12th week
Title
Change in FEV1
Description
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.
Time Frame
Baseline, 12th week
Title
Change in FVC
Description
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.
Time Frame
Baseline, 12th week
Title
Change in FEV1/FVC
Description
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.
Time Frame
Baseline, 12th week
Title
Change in PEF
Description
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.
Time Frame
Baseline, 12th week
Secondary Outcome Measure Information:
Title
Change in weight
Description
Tanita Body Composition Analyzer determines body weight as kilograms (kg).
Time Frame
Baseline, 12th week
Title
Change in body mass index
Description
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.
Time Frame
Baseline, 12th week
Title
Change in body fat percentage
Description
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.
Time Frame
Baseline, 12th week
Title
Change in lean body mass
Description
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.
Time Frame
Baseline, 12th week
Title
Change in severity of dyspnoea
Description
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.
Time Frame
Baseline, 12th week
Title
Change in The Tampa Kinesiophobia Scale for Heart Patients
Description
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.
Time Frame
Baseline, 12th week
Title
Change in The International Physical Activity Questionnaire-short form
Description
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.
Time Frame
Baseline, 12th week
Title
Change in The Fatigue Severity Scale
Description
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.
Time Frame
Baseline, 12th week
Title
Change in The Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Baseline, 12th week
Title
Change in MacNew Heart Disease Health-Related Quality of Life instrument
Description
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.
Time Frame
Baseline, 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elvan Keleş, PT, MSc
Phone
0902323293535
Email
elvan_keles@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hazal Yakut, PT, MSc
Email
fzthazalyakut@outlook.com
Facility Information:
Facility Name
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvan Keleş, PT, MSc
Phone
00902323293535
Email
elvan_keles@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hazal Yakut, PT, MSc
First Name & Middle Initial & Last Name & Degree
Sevgi Özalevli, PT, PhD
First Name & Middle Initial & Last Name & Degree
Ahmet Anıl Başkurt, MD
First Name & Middle Initial & Last Name & Degree
Hüseyin Dursun, MD
First Name & Middle Initial & Last Name & Degree
Aylin Özgen Alpaydın, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34993836
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.
Results Reference
derived
PubMed Identifier
34741536
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.
Results Reference
derived

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Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

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