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Active, Not Recruiting

NCT Number: NCT04555512

A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation

The purpose of the study is to examine the effect of two different high intensity interval training (HIIT) prescription approaches on improving fitness, heart function, and the ability of the body's muscles to receive oxygen.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult 18 years and older.
  • English speaking.
  • Able to provide consent.
  • Has a qualifying indication for center-based cardiac rehabilitation that is non-surgical (i.e., Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, and stable angina).

Exclusion criteria

  • Participants referred to cardiac rehabilitation following coronary artery bypass surgery, heart valve repair/replacement, heart transplant, or those with ventricular assist devices.
  • Patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program are not eligible.
  • Patients unable/unwilling to provide informed consent will not be enrolled.
  • Patients identified as having a contraindication to high intensity exercise.

Treatment and study plan

Progressive High Intensity Interval Training (PRO-HIIT)

Other

Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves progression of training of 3 stages: 1) six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min; 2) three high-intensity intervals of 2-min separated by two low-intensity intervals of 4-min, and a further 2-min of low intensity following the last interval before cool-down; and 3) three high-intensity intervals of 3-min separated by two low-intensity intervals of 3-min, and a further 1-min of low intensity following last interval before cool-down.

Constant High Intensity Interval Training (CON-HIIT)

Other

Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves a constant protocol of training, including six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min.

Primary outcomes

  1. Change in cardiorepiratory fitness

    Time frame: Pre and post study completion, approximately 12 weeks

    Measure as peak oxygen consumption (VO2 peak)

Secondary outcomes

  1. Change in oxygen uptake response time

    Time frame: Weekly, over 12 weeks

    Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset

  2. Change in locomotor muscle oxygenation

    Time frame: Pre and post study completion, 12 weeks

    Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)

  3. Change in metaboreflex stimulation

    Time frame: Pre and post study completion, 12 weeks

    Measured as changes in blood pressure during recovery from exercise

  4. Changes in mechanoreflex stimulation and sensitization

    Time frame: Pre and post study completion, 12 weeks

    Measured as changes in blood pressure during recovery from exercise

  5. Change in cardiac function

    Time frame: Pre and post study completion, 12 weeks

    Measured as global longitudinal strain by echocardiography at rest and during sub-maximal exercise

  6. Change in body composition

    Time frame: Pre and post study completion, 12 weeks

    Measured as fat mass by dual-energy x-ray absorptiometry

  7. Change in blood pressure

    Time frame: Pre and post study completion, 12 weeks

    Measured as resting and mean 24-hr blood pressures by ambulatory blood pressure monitor

  8. Change in blood lipids

    Time frame: Pre and post study completion, 12 weeks

    Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides

  9. Change in physical activity

    Time frame: Pre and post study completion, 12 weeks

    Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Efficacy of Prescription Methods for High-intensity Interval Training in Patients Enrolled in Outpatient Cardiac Rehabilitation

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 18, 2020
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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