- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408614
Acute Effect of Exercise on Vascular Function
January 23, 2019 updated by: University of Florida
The study objectives are the following: 1) To examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) To examine the influence of age and gender on these responses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The type, intensity and duration of exercise, fitness state, and timing of measurements have been reported to influence the acute vascular responses to exercise.
However, little is known regarding the influence of interval training, aging and gender on these responses.
The objectives of this study are: 1) to examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) to examine the influence of age and gender on these responses.
Subjects will perform the following 3 types of treadmill exercise in a random order: 1) slow-pace walking; 2) moderate-pace walking; and 3) interval training.
Flow mediated dilation using high resolution ultrasonography and arterial stiffness using applanation tonometry will be measured before, immediately after and 1-hour after each acute bout of exercise.
Study Type
Observational
Enrollment (Actual)
69
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
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Integrative Cardiovascular Physiology Laboratory
-
-
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
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
General population including men and women 18 to 79 years of age
Description
Inclusion Criteria:
- Men and women 18 to 79 years of age
- Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
- Premenopausal women will be eumenorrheic.
- Able to give consent.
Exclusion Criteria:
- History of hepatic disease or infection with hepatitis B, C or HIV
- History of other relevant on-going or recurrent illness
- Recent (within 3 months) or recurrent hospitalizations
- Current intake of medications that may affect study results
- Use of tobacco products
- Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
- Pregnancy (positive urine pregnancy test) or lactation
- Perimenopausal women
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Slow-paced walking
Subjects will complete 47 minutes of walking at slow pace.
|
Subjects will complete 47 minutes of walking on a treadmill at a slow-pace.
|
Moderate-paced walking
Subjects will complete 47 minutes of walking at a moderate pace.
|
Subjects will complete 47 minutes of walking on a treadmill at a moderate pace.
|
Interval training
Subjects will complete 40 minutes of walking alternating between a moderate and fast pace.
|
Subjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vascular endothelial function
Time Frame: Baseline, 15 minutes after exercise and 1 hour after exercise
|
Brachial artery endothelium-dependent flow-mediated dilation to reactive hyperemia will be measured using high resolution ultrasonography.
Brachial artery diameter and blood velocity will be measured before and after occluding the forearm for 5 minutes by inflating a cuff to 250 mmHg.
|
Baseline, 15 minutes after exercise and 1 hour after exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in arterial stiffness
Time Frame: Baseline, 15 minutes after exercise and 1 hour after exercise
|
Arterial stiffness (aortic pulse wave velocity and augmentation index) will be measured using applanation tonometry.
|
Baseline, 15 minutes after exercise and 1 hour after exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2015
Primary Completion (Actual)
January 23, 2019
Study Completion (Actual)
January 23, 2019
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Actual)
January 25, 2019
Last Update Submitted That Met QC Criteria
January 23, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB201401078
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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