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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Inha University Hospital

Investigators

  • 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)

January 1, 2023

Primary Completion (Anticipated)

July 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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