NCT04407624

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

January 27, 2020

Last Update Submit

May 25, 2020

Conditions

Keywords

Aerobic exerciseIntermittent exercise

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

EXPERIMENTAL

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

Other: Intermittent Exercise

Control Group

ACTIVE COMPARATOR

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

Other: Control

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.

Intermittent Exercise Group
ControlOTHER

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.

Control Group

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

RECRUITING

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.

  • 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.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Elvan Keleş, PT, MSc

CONTACT

Hazal Yakut, PT, MSc

CONTACT

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

Locations