AgingNCT02408614
Acute Effect of Exercise on Vascular Function
An observational study of Aging, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Slow-paced walking, Moderate-paced walking and Interval Training
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 23 Jan 2019
- Phase
- Observational
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population including men and women 18 to 79 years of age
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiovascular Physiology Laboratory
Gainesville, Florida, 32611
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Slow-paced walking, Moderate-paced walking, Interval Training, Treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-paced walkingOther
Subjects will complete 47 minutes of walking on a treadmill at a slow-pace.
Moderate-paced walkingOther
Subjects will complete 47 minutes of walking on a treadmill at a moderate pace.
Interval TrainingOther
Subjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace.
TreadmillDevice
| Study group | Role | What they receive |
|---|---|---|
| Slow-paced walking | Subjects will complete 47 minutes of walking at slow pace. Receives: Other: Slow-paced walking; Device: Treadmill | |
| Moderate-paced walking | Subjects will complete 47 minutes of walking at a moderate pace. Receives: Other: Moderate-paced walking; Device: Treadmill | |
| Interval training | Subjects will complete 40 minutes of walking alternating between a moderate and fast pace. Receives: Other: Interval Training; Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary outcomes (1)
Change in arterial stiffness
Arterial stiffness (aortic pulse wave velocity and augmentation index) will be measured using applanation tonometry.
Measured: Baseline, 15 minutes after exercise and 1 hour after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408614
- Sponsor's protocol ID
- IRB201401078
- Status last verified
- Jan 2019
- First submitted
- 31 Mar 2015
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Exercise on Vascular Function
- ClinicalTrials.gov ID
- NCT02408614
- Acronym / sponsor ID
- IRB201401078
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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 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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow-paced walking | – | Other: Slow-paced walking, Device: TreadmillSubjects will complete 47 minutes of walking at slow pace. |
| Moderate-paced walking | – | Other: Moderate-paced walking, Device: TreadmillSubjects will complete 47 minutes of walking at a moderate pace. |
| Interval training | – | Other: Interval Training, Device: TreadmillSubjects will complete 40 minutes of walking alternating between a moderate and fast pace. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population including men and women 18 to 79 years of age
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Slow-paced walkingSubjects will complete 47 minutes of walking on a treadmill at a slow-pace. | Other | Slow-paced walking |
| Moderate-paced walkingSubjects will complete 47 minutes of walking on a treadmill at a moderate pace. | Other | Moderate-paced walking |
| Interval TrainingSubjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace. | Other | Interval training |
| Treadmill | Device | Interval training, Moderate-paced walking, Slow-paced walking |
Primary outcome
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.
1 secondary outcome
Change in arterial stiffness
Time frame: Baseline, 15 minutes after exercise and 1 hour after exercise
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 25 Jan 2019.
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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.
Demetra Christou, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Florida 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 4 inclusion and 8 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 25 Jan 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?
Change in vascular endothelial function (time frame: Baseline, 15 minutes after exercise and 1 hour after exercise). 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 25 Jan 2019.