Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure

January 3, 2026 updated by: Aya Ibrahim Elshenawy Elshenawy, Cairo University
this study aims to investigate the effect of low vs high volume- high intensity interval training on functional capacity and quality of life in chronic heart failure patients

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.

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 (Estimated)

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.
45

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

  • Egypt
    • Giza Governorate
      • Cairo, Giza Governorate, Egypt

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Chronic stable heart failure patient with reduced ejection fraction (EF <40)
  2. Age Above 18 years old
  3. Both males and females
  4. The ability to provide informed consent

Exclusion Criteria:

  1. Based on the Scientific Statement from the American Heart Association: contraindications for exercise Testing and Training. (Fletcher et al., 2013)

    1. Acute myocardial infarction (MI), within 2 days
    2. Ongoing unstable angina
    3. Uncontrolled cardiac tachy or brady arrhythmia with hemodynamic compromise
    4. Active endocarditis
    5. Symptomatic severe aortic stenosis
    6. Decompensated heart failure
    7. Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
    8. Acute myocarditis or pericarditis
    9. Acute aortic dissection
    10. Physical disability that precludes safe and adequate testing or training
    11. Known obstructive left main coronary artery stenosis
    12. Hypertrophic obstructive cardiomyopathy with severe resting gradient
    13. Recent stroke or transient ischemic attack
    14. Mental impairment with limited ability to cooperate
    15. Resting hypertension with systolic or diastolic blood pressures >200/110 mmHg
    16. Uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism
  2. Acute decompensated heart failure NYHA class IV

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: None (Open Label)

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.
Experimental: Low volume high intensity interval training
This group will receive the usual care (standard medical treatment) in addition to LV-HIIT on a treadmill for 8 weeks, 2 sessions per week.
Other: low-volume high intensity interval training
Low-volume HIIT (LV-HIIT) is a particularly time-efficient subtype of interval training, which has gained increasing attention in recent years. As per the previous definition, these brief training protocols typically involve≤10 min of intense exercise within a session lasting≤30 min including warm-up, recovery phases between intervals, and cool-down
Drug: Standard medical treatment
standard medical treatment for chronic heart failure as per international guidlines
Experimental: high volume high intensity interval training
In this group, the patients will receive the usual care (standard treatment) in addition to HV-HIIT on a treadmill for 8 weeks, 2 sessions per week
Drug: Standard medical treatment
standard medical treatment for chronic heart failure as per international guidlines
Other: High volume high intensity interval training
long (2-4 min) bouts of high (not maximum) intensity exercise interspersed with recovery periods which have wide varieties in the protocols according to the intensity, duration, and number of intervals performed
Other: control group
It includes 15 patients who will receive standard medical treatment only
Drug: Standard medical treatment
standard medical treatment for chronic heart failure as per international guidlines

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
6 minute walk test
Time Frame: at enrolment and at the end of treatment at 8 weeks
self-paced submaximal field exercise test to assess submaximal functional capacity of the patient , the distance walked by the patient for six minutes will be measured by meters
at enrolment and at the end of treatment at 8 weeks
2D Echocardiographic parameters
Time Frame: at enrollment and at the end of treatment at 8 weeks

Left ventricle geometry: left ventricular end-diastolic diameter (LVEDD) mm, left ventricular end-systolic diameter (LVESD) mm, left ventricular end-systolic volume (LVESV) ml. and, left ventricular end-diastolic volume (LVEDV) ml.

Left ventricle Systolic function: left ventricular ejection fraction (LVEF) % Left ventricle Diastolic function :E wave cm/s: early diastolic mitral inflow velocity, A wave cm/s: diastolic mitral inflow velocity during late atrial contraction , E/A ratio
at enrollment and at the end of treatment at 8 weeks

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
Minnesota living with heart failure questionnaire (MLHFQ)
Time Frame: at enrollment and at the end of treatment at 8 weeks
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the tool most widely used and recognized to assess HRQOL in adults with Hf, was developed in 1987 by Thomas Rector, focusing on the underlying relationship between pathophysiology, symptoms, functional limitations, and psychological distress, it measures the impacts of symptoms and treatment on different dimensions of HRQOL in HF patients.
at enrollment and at the end of treatment at 8 weeks

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.
Cairo University

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 (Estimated)

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.
December 10, 2025

Primary Completion (Estimated)

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.
June 6, 2026

Study Completion (Estimated)

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.
June 6, 2026

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 9, 2025

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.
January 3, 2026

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.
January 8, 2026

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.
January 8, 2026

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.
January 3, 2026

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.
January 1, 2026

More Information

Terms related to this study

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.
  • P.T.REC/012/005825

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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