- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602170
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
20
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: High-Intensity Interval Training
8 weeks of high-intensity interval training.
Three sessions per week will be performed (24 total sessions).
|
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).
|
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
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
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
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
Investigators
- 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)
March 30, 2017
Primary Completion (Actual)
November 6, 2018
Study Completion (Actual)
November 6, 2018
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
July 18, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 25, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID 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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