High Intensity Interval Training in Chronic Heart Failure

February 28, 2023 updated by: Joa KyungLim, Inha University Hospital

The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure

The aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

enroll chronic heart failure patients into 3 randomized controlled group

  • high intensity interval training
  • moderate intensity continous training
  • control

perform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Kyunggi-do
      • Incheon, Kyunggi-do, Korea, Republic of, 07980
        • Recruiting
        • Inha University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medically stable chronic heart failure
  • NYHA II-III
  • can perform cardiopulmonary exercise test
  • after 3months with proper medication
  • age 30 to 70
  • ejection fraction< 40%

Exclusion Criteria:

  • contraindication to cardiopulmonary exercise test
  • musculoskeletal problem who cannot perform cardiopulmonary exercise test
  • cognition deficit who cannot understand directions
  • severe medial illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor
Experimental: High intensity interval training
Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor
Active Comparator: Moderate intensity continous training
Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)
Time Frame: compare baseline data with 12 weeks rehabilitation data
at the end of training, from baseline to 12 weeks
compare baseline data with 12 weeks rehabilitation data

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anaerobic threshold (kg/ml/min)
Time Frame: compare baseline data with 12 weeks rehabilitation data
The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood.
compare baseline data with 12 weeks rehabilitation data
6minute walk test (meter)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
maximal heart rate (bpm)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
systolic blood pressure (mmHg)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
diastolic blood pressure (mmHg)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
resting heart rate (bpm)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
diastolic blood presure (mmHg)
Time Frame: compare baseline data with 12 weeks rehabilitation data
compare baseline data with 12 weeks rehabilitation data
depression scale by Patient Health Questionnaire
Time Frame: compare baseline data with 12 weeks rehabilitation data
Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression)
compare baseline data with 12 weeks rehabilitation data
anxiety scale by Generalized Anxiety Disorder Scale
Time Frame: compare baseline data with 12 weeks rehabilitation data
Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety)
compare baseline data with 12 weeks rehabilitation data
fatigue scale by fatigue severity scale
Time Frame: compare baseline data with 12 weeks rehabilitation data
fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue)
compare baseline data with 12 weeks rehabilitation data
Quality of Life (QoL) questionnaire (MacNew)
Time Frame: compare baseline data with 12 weeks rehabilitation data
MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL.
compare baseline data with 12 weeks rehabilitation data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inha University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyung-Lim Joa, M.D., Department of physical medicine and rehabilitation, Inha University hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • InhaUH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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