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

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555512
• Other study ID #: 20-005923
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Jenna-Lee Taylor, PhD
• Phone: (507) 284-1329
• Email: Taylor.Jenna-lee[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiorepiratory fitness	Measure as peak oxygen consumption (VO2 peak)	Pre and post study completion, approximately 12 weeks
Secondary	Change in oxygen uptake response time	Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset	Weekly, over 12 weeks
Secondary	Change in locomotor muscle oxygenation	Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)	Pre and post study completion, 12 weeks
Secondary	Change in metaboreflex stimulation	Measured as changes in blood pressure during recovery from exercise	Pre and post study completion, 12 weeks
Secondary	Changes in mechanoreflex stimulation and sensitization	Measured as changes in blood pressure during recovery from exercise	Pre and post study completion, 12 weeks
Secondary	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
Secondary	Change in body composition	Measured as fat mass by dual-energy x-ray absorptiometry	Pre and post study completion, 12 weeks
Secondary	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
Secondary	Change in blood lipids	Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides	Pre and post study completion, 12 weeks
Secondary	Change in physical activity	Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor	Pre and post study completion, 12 weeks