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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03602170
Other study ID # 1009103-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2017
Est. completion date November 6, 2018

Study information

Verified date April 2019
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 6, 2018
Est. primary completion date November 6, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Healthy Sedentary Adults With BP <140/90

Intervention

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.
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.

Locations

Country Name City State
United States Department of Kinesiology and Applied Physiology, University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Perceived Enjoyment of Exercise Enjoyment rating based on 18-item questionnaire Measured after 4 and 8 weeks of training
Primary Blood Pressure Resting blood pressures measuring by automated oscillometric device Change from baseline resting blood pressure at 8 weeks
Secondary Peak Aerobic Capacity Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion Change from baseline VO2peak at 8 weeks
Secondary 24-Hour Ambulatory Blood Pressure 24 hours of continuous ambulatory blood pressure monitoring by oscillometric device Change from baseline 24-hour ambulatory blood pressure at 8 weeks
Secondary Pulse Wave Analysis Central blood pressure measures assessed by radial tonometry Change from baseline central blood pressure measures at 8 weeks
Secondary Endothelial Function 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
Secondary Arterial stiffness 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
Secondary Blood Pressure Reactivity Blood pressure response to graded exercise test and handgrip exercise Change from baseline blood pressure reactivity at 8 weeks