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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Other: Constant High Intensity Interval Training (CON-HIIT); Other: Progressive High Intensity Interval Training (PRO-HIIT)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna-Lee Taylor, PhD; Phone Number: (507) 284-1329; Email: Taylor.Jenna-lee@mayo.edu
• Study Contact Backup: Name: Amanda R Bonikowske, PhD; Email: bonikowske.amanda@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard-care interval-training group; 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); 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.
Experimental: Progressive interval-training group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiorepiratory fitness	Measure as peak oxygen consumption (VO2 peak)	Pre and post study completion, approximately 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygen uptake response time	Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset	Weekly, over 12 weeks
Change in locomotor muscle oxygenation	Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)	Pre and post study completion, 12 weeks
Change in metaboreflex stimulation	Measured as changes in blood pressure during recovery from exercise	Pre and post study completion, 12 weeks
Changes in mechanoreflex stimulation and sensitization	Measured as changes in blood pressure during recovery from exercise	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	Pre and post study completion, 12 weeks
Change in body composition	Measured as fat mass by dual-energy x-ray absorptiometry	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	Pre and post study completion, 12 weeks
Change in blood lipids	Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides	Pre and post study completion, 12 weeks
Change in physical activity	Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor	Pre and post study completion, 12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Amanda R Bonikowske, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-005923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No