Cardiac RehabilitationNCT04555512
A Study to Compare the Effectiveness of Different High-intensity Interval Training Programs in Cardiac Rehabilitation
A study testing Progressive High Intensity Interval Training (PRO-HIIT) and Constant High Intensity Interval Training (CON-HIIT) in people with Cardiac Rehabilitation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Progressive High Intensity Interval Training (PRO-HIIT) and Constant High Intensity Interval Training (CON-HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Efficacy of Prescription Methods for High-intensity Interval Training in Patients Enrolled in Outpatient 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Progressive High Intensity Interval Training (PRO-HIIT), Constant High Intensity Interval Training (CON-HIIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-care interval-training group | Active comparator | Subjects will complete a standard interval-training program that remains constant for the entire 12 weeks of cardiac rehabilitation. Receives: Other: Constant High Intensity Interval Training (CON-HIIT) |
| Progressive interval-training group | Experimental | Subjects will complete an interval-training program during which the number of intervals and the duration of each interval are changed across the 12-week cardiac rehabilitation program. Receives: Other: Progressive High Intensity Interval Training (PRO-HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorepiratory fitness
Measure as peak oxygen consumption (VO2 peak)
Measured: Pre and post study completion, approximately 12 weeks
Secondary outcomes (9)
Change in oxygen uptake response time
Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset
Measured: Weekly, over 12 weeks
Change in locomotor muscle oxygenation
Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)
Measured: Pre and post study completion, 12 weeks
Change in metaboreflex stimulation
Measured as changes in blood pressure during recovery from exercise
Measured: Pre and post study completion, 12 weeks
Changes in mechanoreflex stimulation and sensitization
Measured as changes in blood pressure during recovery from exercise
Measured: Pre and post study completion, 12 weeks
Change in cardiac function
Measured as global longitudinal strain by echocardiography at rest and during sub-maximal exercise
Measured: Pre and post study completion, 12 weeks
Change in body composition
Measured as fat mass by dual-energy x-ray absorptiometry
Measured: Pre and post study completion, 12 weeks
Change in blood pressure
Measured as resting and mean 24-hr blood pressures by ambulatory blood pressure monitor
Measured: Pre and post study completion, 12 weeks
Change in blood lipids
Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides
Measured: Pre and post study completion, 12 weeks
Change in physical activity
Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor
Measured: Pre and post study completion, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start23 Jun 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda R. Bonikowske, Mayo Clinic
- Investigators
- Amanda R Bonikowske, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555512
- Sponsor's protocol ID
- 20-005923
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2020
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prescription Methods for High-intensity Interval Training in Patients Enrolled in Outpatient Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04555512
- Acronym / sponsor ID
- 20-005923
- Conditions
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-care interval-training group | Active comparator | Other: Constant High Intensity Interval Training (CON-HIIT)Subjects will complete a standard interval-training program that remains constant for the entire 12 weeks of cardiac rehabilitation. |
| Progressive interval-training group | Experimental | Other: Progressive High Intensity Interval Training (PRO-HIIT)Subjects will complete an interval-training program during which the number of intervals and the duration of each interval are changed across the 12-week cardiac rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive High Intensity Interval Training (PRO-HIIT)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. | Other | Progressive interval-training group |
| Constant High Intensity Interval Training (CON-HIIT)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. | Other | Standard-care interval-training group |
Primary outcome
Change in cardiorepiratory fitness
Time frame: Pre and post study completion, approximately 12 weeks
Measure as peak oxygen consumption (VO2 peak)
9 secondary outcomes
Change in oxygen uptake response time
Time frame: Weekly, over 12 weeks
Change in locomotor muscle oxygenation
Time frame: Pre and post study completion, 12 weeks
Change in metaboreflex stimulation
Time frame: Pre and post study completion, 12 weeks
Changes in mechanoreflex stimulation and sensitization
Time frame: Pre and post study completion, 12 weeks
Change in cardiac function
Time frame: Pre and post study completion, 12 weeks
Change in body composition
Time frame: Pre and post study completion, 12 weeks
Change in blood pressure
Time frame: Pre and post study completion, 12 weeks
Change in blood lipids
Time frame: Pre and post study completion, 12 weeks
Change in physical activity
Time frame: Pre and post study completion, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardiac Rehabilitation
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruiting
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Recruiting
Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair
Abdominal Aortic Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda R Bonikowske, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive High Intensity Interval Training (PRO-HIIT) and Constant High Intensity Interval Training (CON-HIIT) in people with Cardiac Rehabilitation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorepiratory fitness (time frame: Pre and post study completion, approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.