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Cardiovascular Effects of High-Intensity Interval Training (HIIT)

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ClinicalTrials.gov Identifier: NCT03602170
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
David Edwards, University of Delaware

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Sedentary Adults With BP <140/90 Behavioral: High-Intensity Interval Training Behavioral: Moderate-Intensity Continuous Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCT)
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018

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).
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.




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Change from baseline resting blood pressure at 8 weeks ]
    Resting blood pressures measuring by automated oscillometric device


Secondary Outcome Measures :
  1. Peak Aerobic Capacity [ Time Frame: Change from baseline VO2peak at 8 weeks ]
    Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion

  2. 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

  3. Pulse Wave Analysis [ Time Frame: Change from baseline central blood pressure measures at 8 weeks ]
    Central blood pressure measures assessed by radial tonometry

  4. 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

  5. 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

  6. Blood Pressure Reactivity [ Time Frame: Change from baseline blood pressure reactivity at 8 weeks ]
    Blood pressure response to graded exercise test and handgrip exercise


Other Outcome Measures:
  1. Perceived Enjoyment of Exercise [ Time Frame: Measured after 4 and 8 weeks of training ]
    Enjoyment rating based on 18-item questionnaire



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03602170


Locations
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United States, Delaware
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, United States, 19713
Sponsors and Collaborators
University of Delaware
Investigators
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Principal Investigator: Bryce J Muth, MS University of Delaware
Principal Investigator: David G Edwards, PhD University of Delaware

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Responsible Party: David Edwards, Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT03602170     History of Changes
Other Study ID Numbers: 1009103-6
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Edwards, University of Delaware:
High-Intensity Interval Training
Exercise
Cardiovascular Health
Blood Pressure