Cardiovascular Effects of High-Intensity Interval Training (HIIT)

April 25, 2019 updated by: David Edwards, University of Delaware

Cardiovascular Effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCT)

The purpose of this study is to determine the effect of high-intensity interval training (HIIT) in comparison to moderate-intensity continuous training (MCT) on blood pressure, blood vessel function, and blood pressure reactivity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is estimated that one-third of the adult population in the United States has blood pressure values that are classified as prehypertension. This slight elevation in blood pressure has been shown to result in an increased risk for developing hypertension and cardiovascular disease. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends lifestyle modifications for individuals classified as prehypertensive. One lifestyle modification suggested by JNC7 is regular physical activity. Aerobic exercise, like moderate-intensity continuous training (MCT), has been shown to improve blood pressure, blood vessel function, and arterial stiffness in those with prehypertension. However, a major barrier to exercise adherence is the time commitment required. High-Intensity Interval Training (HIIT), which requires individuals to work at higher intensities for shorter durations, may offer an alternative training design that would reduce the time commitment. Previous studies have shown HIIT to be equal to or better at improving cardiorespiratory fitness and blood vessel function in multiple populations. Limited information is present on HIIT training in those with prehypertension. In this study, participants will be randomized into one of the two training program designs mentioned above (MCT or HIIT). Both programs will be completed over an 8-week period (3 sessions per week) and each training session will be supervised. Participants will complete testing visits before and after the training program to collect measures of cardiovascular health (exercise capacity, blood pressure, blood vessel function, and blood pressure reactivity). The goal is to compare the effects of the training programs on these measures of cardiovascular health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Department of Kinesiology and Applied Physiology, University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Blood Pressure less than 140/90 mmHg
  • Sedentary

Exclusion Criteria:

  • Known or major signs/symptoms of cardiovascular, pulmonary, renal, or metabolic disease
  • Cancer
  • Use of antihypertensive medication
  • Current tobacco use
  • BMI (body mass index) less than 30 kg/m2
  • Postmenopausal
  • Current pregnancy
  • Current hormone replacement therapy
  • Participating in regular aerobic exercise at least three times a week for 30 minutes at a moderate intensity for the past 3 months or more
  • Not able to regularly exercise for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Intensity Interval Training
8 weeks of high-intensity interval training. Three sessions per week will be performed (24 total sessions).
Behavioral: High-Intensity Interval Training
Supervised exercise sessions will be performed on a upright cycle ergometer. Training sessions involve 20 minutes of exercise by completing 10 repetitions of 60 seconds of exercise at 90-95% maximal heart rate with 60 seconds of active rest between each repetition at 50-60% maximal heart rate.
Active Comparator: Moderate-Intensity Continuous Training
8 weeks of moderate-intensity continuous training. Three sessions per week will be performed (24 total sessions).
Behavioral: Moderate-Intensity Continuous Training
Supervised exercise sessions will be performed on a upright cycle ergometer. Training sessions involve 30 minutes of continuous exercise at 65-70% maximal heart rate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Change from baseline resting blood pressure at 8 weeks
Resting blood pressures measuring by automated oscillometric device
Change from baseline resting blood pressure at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Aerobic Capacity
Time Frame: Change from baseline VO2peak at 8 weeks
Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion
Change from baseline VO2peak at 8 weeks
24-Hour Ambulatory Blood Pressure
Time Frame: Change from baseline 24-hour ambulatory blood pressure at 8 weeks
24 hours of continuous ambulatory blood pressure monitoring by oscillometric device
Change from baseline 24-hour ambulatory blood pressure at 8 weeks
Pulse Wave Analysis
Time Frame: Change from baseline central blood pressure measures at 8 weeks
Central blood pressure measures assessed by radial tonometry
Change from baseline central blood pressure measures at 8 weeks
Endothelial Function
Time Frame: Change from baseline endothelial function at 8 weeks
Assessed by brachial artery flow mediated dilation and change in blood in femoral artery in response to passive limb movement
Change from baseline endothelial function at 8 weeks
Arterial stiffness
Time Frame: Change from baseline pulse wave velocity measures at 8 weeks
Pulse wave velocity measures (carotid to femoral and femoral to distal) assessed by applanation tonometry
Change from baseline pulse wave velocity measures at 8 weeks
Blood Pressure Reactivity
Time Frame: Change from baseline blood pressure reactivity at 8 weeks
Blood pressure response to graded exercise test and handgrip exercise
Change from baseline blood pressure reactivity at 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Enjoyment of Exercise
Time Frame: Measured after 4 and 8 weeks of training
Enjoyment rating based on 18-item questionnaire
Measured after 4 and 8 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Delaware

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David G Edwards, PhD, University of Delaware
  • Principal Investigator: Bryce J Muth, MS, University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1009103-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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