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

Not Applicable

Recruiting

• Conditions: Cardiac Rehabilitation
• Interventions: Other: Constant High Intensity Interval Training (CON-HIIT); Other: Progressive High Intensity Interval Training (PRO-HIIT)

• Registration Number: NCT04555512
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2021-06-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-care interval-training group	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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in mechanoreflex stimulation and sensitization	Pre and post study completion, 12 weeks	Measured as changes in blood pressure during recovery from exercise
Change in blood pressure	Pre and post study completion, 12 weeks	Measured as resting and mean 24-hr blood pressures by ambulatory blood pressure monitor
Change in locomotor muscle oxygenation	Pre and post study completion, 12 weeks	Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)
Change in cardiac function	Pre and post study completion, 12 weeks	Measured as global longitudinal strain by echocardiography at rest and during sub-maximal exercise
Change in blood lipids	Pre and post study completion, 12 weeks	Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides
Change in oxygen uptake response time	Weekly, over 12 weeks	Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset
Change in metaboreflex stimulation	Pre and post study completion, 12 weeks	Measured as changes in blood pressure during recovery from exercise
Change in body composition	Pre and post study completion, 12 weeks	Measured as fat mass by dual-energy x-ray absorptiometry
Change in physical activity	Pre and post study completion, 12 weeks	Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States