NCT03602170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

June 21, 2018

Last Update Submit

April 25, 2019

Conditions

Healthy Sedentary Adults With BP <140/90

Keywords

High-Intensity Interval TrainingExerciseCardiovascular HealthBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Resting blood pressures measuring by automated oscillometric device

    Change from baseline resting blood pressure at 8 weeks

Secondary Outcomes (6)

  • Peak Aerobic Capacity

    Change from baseline VO2peak at 8 weeks

  • 24-Hour Ambulatory Blood Pressure

    Change from baseline 24-hour ambulatory blood pressure at 8 weeks

  • Pulse Wave Analysis

    Change from baseline central blood pressure measures at 8 weeks

  • Endothelial Function

    Change from baseline endothelial function at 8 weeks

  • Arterial stiffness

    Change from baseline pulse wave velocity measures at 8 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Perceived Enjoyment of Exercise

    Measured after 4 and 8 weeks of training

Study Arms (2)

High-Intensity Interval Training

EXPERIMENTAL

8 weeks of high-intensity interval training. Three sessions per week will be performed (24 total sessions).

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).

Behavioral: Moderate-Intensity Continuous Training

Interventions

High-Intensity Interval TrainingBEHAVIORAL

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.

High-Intensity Interval Training
Moderate-Intensity Continuous TrainingBEHAVIORAL

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.

Moderate-Intensity Continuous Training

Eligibility Criteria

Age20 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Blood Pressure less than 140/90 mmHg
  • Sedentary

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bryce J Muth, MS

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • David G Edwards, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 26, 2018

Study Start

March 30, 2017

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

US(1)