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

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ClinicalTrials.gov Identifier: NCT04555512
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Amanda R. Bonikowske, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Rehabilitation Other: Progressive High Intensity Interval Training (PRO-HIIT) Other: Constant High Intensity Interval Training (CON-HIIT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy of Prescription Methods for High-intensity Interval Training in Patients Enrolled in Outpatient Cardiac Rehabilitation
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in cardiorepiratory fitness [ Time Frame: Pre and post study completion, approximately 12 weeks ]
    Measure as peak oxygen consumption (VO2 peak)


Secondary Outcome Measures :
  1. Change in oxygen uptake response time [ Time Frame: Weekly, over 12 weeks ]
    Measured as exponential time-constant of pulmonary oxygen uptake at exercise onset

  2. Change in locomotor muscle oxygenation [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as tissue oxygen saturation by near-infrared spectroscopy (NIRS)

  3. Change in metaboreflex stimulation [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as changes in blood pressure during recovery from exercise

  4. Changes in mechanoreflex stimulation and sensitization [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as changes in blood pressure during recovery from exercise

  5. Change in cardiac function [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as global longitudinal strain by echocardiography at rest and during sub-maximal exercise

  6. Change in body composition [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as fat mass by dual-energy x-ray absorptiometry

  7. Change in blood pressure [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as resting and mean 24-hr blood pressures by ambulatory blood pressure monitor

  8. Change in blood lipids [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as total-cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides

  9. Change in physical activity [ Time Frame: Pre and post study completion, 12 weeks ]
    Measured as minutes spent in moderate-vigorous physical activity, by accelerometer monitor


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555512


Contacts
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Contact: Jenna Taylor, PhD (507) 284-1329 Taylor.Jenna-lee@mayo.edu
Contact: Shane Hammer, PhD (507) 284-1329 hammer.shane@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Amanda Bonikowske, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Amanda R. Bonikowske, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04555512    
Other Study ID Numbers: 20-005923
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No