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

NCT04555512 | Active Not Recruiting

• 1 other identifier: 20-005923
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in cardiorepiratory fitness

  Measure as peak oxygen consumption (VO2 peak)

  Pre and post study completion, approximately 12 weeks

Secondary Outcomes (9)

• Change in oxygen uptake response time

  Weekly, over 12 weeks

• Change in locomotor muscle oxygenation

  Pre and post study completion, 12 weeks

• Change in metaboreflex stimulation

  Pre and post study completion, 12 weeks

• Changes in mechanoreflex stimulation and sensitization

  Pre and post study completion, 12 weeks

• Change in cardiac function

  Pre and post study completion, 12 weeks

Study Arms (2)

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.

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.

Other: Progressive High Intensity Interval Training (PRO-HIIT)

Interventions

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.

Progressive interval-training group

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.

Standard-care interval-training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Amanda R Bonikowske, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 18, 2020
• Study Start: June 23, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)