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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02408614
Other study ID # IRB201401078
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date January 23, 2019

Study information

Verified date January 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date January 23, 2019
Est. primary completion date January 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Slow-paced walking
Subjects will complete 47 minutes of walking on a treadmill at a slow-pace.
Moderate-paced walking
Subjects will complete 47 minutes of walking on a treadmill at a moderate pace.
Interval Training
Subjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace.
Device:
Treadmill


Locations

Country Name City State
United States Integrative Cardiovascular Physiology Laboratory Gainesville Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in vascular endothelial function 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 Change in arterial stiffness 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
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