Healthy Sedentary Adults With BP <140/90NCT03602170
Cardiovascular Effects of High-Intensity Interval Training (HIIT)
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Healthy Sedentary Adults With BP <140/90, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 44 years
- Conditions the study is for
- Healthy Sedentary Adults With BP <140/90
- What is being tested?
- High-Intensity Interval Training and Moderate-Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Blood Pressure less than 140/90 mmHg
- Sedentary
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Sedentary Adults With BP <140/90
- Being tested
- High-Intensity Interval Training, Moderate-Intensity Continuous Training
- Keywords
- High-Intensity Interval Training, Exercise, Cardiovascular Health, Blood Pressure
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | 8 weeks of high-intensity interval training. Three sessions per week will be performed (24 total sessions). Receives: Behavioral: High-Intensity Interval Training |
| Moderate-Intensity Continuous Training | Active comparator | 8 weeks of moderate-intensity continuous training. Three sessions per week will be performed (24 total sessions). Receives: Behavioral: Moderate-Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Resting blood pressures measuring by automated oscillometric device
Measured: Change from baseline resting blood pressure at 8 weeks
Secondary outcomes (6)
Peak Aerobic Capacity
Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion
Measured: Change from baseline VO2peak at 8 weeks
24-Hour Ambulatory Blood Pressure
24 hours of continuous ambulatory blood pressure monitoring by oscillometric device
Measured: Change from baseline 24-hour ambulatory blood pressure at 8 weeks
Pulse Wave Analysis
Central blood pressure measures assessed by radial tonometry
Measured: Change from baseline central blood pressure measures at 8 weeks
Endothelial Function
Assessed by brachial artery flow mediated dilation and change in blood in femoral artery in response to passive limb movement
Measured: Change from baseline endothelial function at 8 weeks
Arterial stiffness
Pulse wave velocity measures (carotid to femoral and femoral to distal) assessed by applanation tonometry
Measured: Change from baseline pulse wave velocity measures at 8 weeks
Blood Pressure Reactivity
Blood pressure response to graded exercise test and handgrip exercise
Measured: Change from baseline blood pressure reactivity at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start30 Mar 2017
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Sedentary Adults With BP <140/90Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Edwards, University of Delaware
- Investigators
- Bryce J Muth, MS, Principal investigator, University of DelawareDavid G Edwards, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602170
- Sponsor's protocol ID
- 1009103-6
- Status last verified
- Apr 2019
- First submitted
- 21 Jun 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MCT)
- ClinicalTrials.gov ID
- NCT03602170
- Acronym / sponsor ID
- 1009103-6
- Conditions
- Healthy Sedentary Adults With BP <140/90
- Keywords
- High-Intensity Interval Training, Exercise, Cardiovascular Health, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval Training8 weeks of high-intensity interval training. Three sessions per week will be performed (24 total sessions). |
| Moderate-Intensity Continuous Training | Active comparator | Behavioral: Moderate-Intensity Continuous Training8 weeks of moderate-intensity continuous training. Three sessions per week will be performed (24 total sessions). |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Blood Pressure less than 140/90 mmHg
- Sedentary
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval TrainingSupervised 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. | Behavioural | High-Intensity Interval Training |
| Moderate-Intensity Continuous TrainingSupervised exercise sessions will be performed on a upright cycle ergometer. Training sessions involve 30 minutes of continuous exercise at 65-70% maximal heart rate. | Behavioural | Moderate-Intensity Continuous Training |
Primary outcome
Blood Pressure
Time frame: Change from baseline resting blood pressure at 8 weeks
Resting blood pressures measuring by automated oscillometric device
6 secondary outcomes
Peak Aerobic Capacity
Time frame: 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
Pulse Wave Analysis
Time frame: Change from baseline central blood pressure measures at 8 weeks
Endothelial Function
Time frame: Change from baseline endothelial function at 8 weeks
Arterial stiffness
Time frame: Change from baseline pulse wave velocity measures at 8 weeks
Blood Pressure Reactivity
Time frame: Change from baseline blood pressure reactivity at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryce J Muth, MS principal investigator
University of Delaware
David G Edwards, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Moderate-Intensity Continuous Training in people with Healthy Sedentary Adults With BP <140/90, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Change from baseline resting blood pressure at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019; AzTrials last refreshed its copy on 1 Nov 2026.