AgingNCT04128215

Sex Differences in Vascular Responses to Exercise

A study testing Exercise Period in people with Aging, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Aging
What is being tested?: Exercise Period
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: 22 Nov 2019to 31 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

adults able to give consent
men and women
women must be postmenopausal (either natural or surgical)
60 to 79 years of age

Who cannot join

any relevant cardiovascular diseases (e.g., history of coronary artery bypass surgery or angioplasty, or heart failure, myocardial infarction, angina pectoris, peripheral arterial disease)
myocardial ischemia during maximal graded exercise test
major chronic clinical disease (e.g., diabetes, renal or hepatic disease or infection with hepatitis B, C, or HIV)
seizures, or other relevant on-going or recurrent illness
recent (within 3 months) or recurrent hospitalizations
systolic blood pressure < 100 mmHg

Show all 11Show fewer

body mass index > 35 kg/m^2
>5% weight change in past 3 months or unwilling to remain weight stable during study participation
use of tobacco products including smoking traditional or e-cigarettes
use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
regular aerobic exercise training (≥30 min/session and ≥ 3 days/week)

Trial locations and contacts

1 site in 1 country.

United States1 site

Integrative Cardiovasculal Physiology Laboratory, University of Florida
Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Sex Differences in Chronic and Acute Vascular Responses to Aerobic Exercise in Older Adults

A key early event in cardiovascular disease development is endothelial dysfunction, characterized by impaired flow-mediated dilation. Regular aerobic exercise ameliorates endothelial dysfunction in healthy older men, but the data in healthy postmenopausal women are inconsistent with many studies showing no effect. The primary objective of this study was to examine sex differences in acute and chronic endothelial responses to exercise training in older men vs. older postmenopausal women.

Conditions: Aging
Being tested: Control Period, Exercise Period
Keywords: High-Intensity Interval Training, Aerobic exercise, Acute exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control PeriodBehavioural
Participants completed an 8-week control period of normal lifestyle.
Exercise PeriodBehavioural
Participants completed an 8-week exercise intervention period of remotely supervised home-based non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT consisted of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax were included.

Study groups in NCT04128215
Study group	Role	What they receive
Older Men	Active comparator	Not described Receives: Behavioral: Control Period; Behavioral: Exercise Period
Older Postmenopausal Women	Active comparator	Not described Receives: Behavioral: Control Period; Behavioral: Exercise Period

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in FMD in Response to Chronic HIIT
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. The change in FMD for the control period was calculated as the difference in FMD from baseline to the end of the 8-week control period. The change in FMD for the exercise intervention period was calculated as the difference in FMD from the end of the 8-week control period to the end of the 8-week intervention period.
Measured: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention
Change in FMD in Response to Acute HIIT in the Untrained State
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the untrained state (before beginning the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Measured: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
Change in FMD in Response to Acute HIIT in the Trained State
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the trained state (at the end of the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Measured: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT
Measured: Acute FMD response at 1) pre-exercise vs. end of exercise; 2) pre-exercise vs. 1-hour post-exercise; and 3) pre-exercise vs. 24-hours post-exercise. Chronic FMD response at baseline vs. end of 8-week. exercise intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 201931 May 2023

First posted16 Oct 2019
Study start22 Nov 2019
Primary completion31 May 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04128215
Sponsor's protocol ID: IRB201902165- N
Other IDs: R21AG063143
Status last verified: Oct 2024
First submitted: 14 Oct 2019
Last updated: 14 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sex Differences in Chronic and Acute Vascular Responses to Aerobic Exercise in Older Adults
ClinicalTrials.gov ID: NCT04128215
Acronym / sponsor ID: IRB201902165- N
Conditions: Aging
Keywords: High-Intensity Interval Training, Aerobic exercise, Acute exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 22 Nov 2019 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 16 Oct 2019 (actual)
Results: Posted 14 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Older Men	Active comparator	Behavioral: Control Period, Behavioral: Exercise Period
Older Postmenopausal Women	Active comparator	Behavioral: Control Period, Behavioral: Exercise Period

Who may qualify

Ages: 60 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adults able to give consent
men and women
women must be postmenopausal (either natural or surgical)
60 to 79 years of age

Key exclusion criteria (11 listed)

any relevant cardiovascular diseases (e.g., history of coronary artery bypass surgery or angioplasty, or heart failure, myocardial infarction, angina pectoris, peripheral arterial disease)
myocardial ischemia during maximal graded exercise test
major chronic clinical disease (e.g., diabetes, renal or hepatic disease or infection with hepatitis B, C, or HIV)
seizures, or other relevant on-going or recurrent illness
recent (within 3 months) or recurrent hospitalizations

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
Control PeriodParticipants completed an 8-week control period of normal lifestyle.	Behavioural	Older Men, Older Postmenopausal Women
Exercise PeriodParticipants completed an 8-week exercise intervention period of remotely supervised home-based non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT consisted of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax were included.	Behavioural	Older Men, Older Postmenopausal Women

Primary outcome

Change in FMD in Response to Chronic HIIT
Time frame: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. The change in FMD for the control period was calculated as the difference in FMD from baseline to the end of the 8-week control period. The change in FMD for the exercise intervention period was calculated as the difference in FMD from the end of the 8-week control period to the end of the 8-week intervention period.
Change in FMD in Response to Acute HIIT in the Untrained State
Time frame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the untrained state (before beginning the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Change in FMD in Response to Acute HIIT in the Trained State
Time frame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise
Flow mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD was determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. FMD was expressed as % change and was calculated as (max diameter-baseline-diameter)/baseline diameter)*100. FMD was investigated at pre-exercise, at the end of a HIIT session, and 1-hour and 24-hours following a HIIT session in the trained state (at the end of the 8-week exercise intervention consisting of HIIT). The change in FMD in response to acute HIIT was calculated 1) at the end of exercise (as the difference from pre-exercise to end of exercise); 2) 1-hour post-exercise (as the difference from pre-exercise to 1-hour post-exercise) and 3) 24-hours post-exercise (as the difference from pre-exercise to 24-hours post-exercise).
Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT
Time frame: Acute FMD response at 1) pre-exercise vs. end of exercise; 2) pre-exercise vs. 1-hour post-exercise; and 3) pre-exercise vs. 24-hours post-exercise. Chronic FMD response at baseline vs. end of 8-week. exercise intervention

Results and safety

Results posted to the registry on 14 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Older Men	9	9
Older Postmenopausal Women	11	11

Primary outcome: Change in FMD in Response to Chronic HIIT

Time frame: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention. Mean (Standard Deviation). Unit: % flow mediated dilation

Measure	Older Postmenopausal Women n = 11	Older Men n = 9
Control period	0.11 (1.27)	0.57 (2.07)
Exercise intervention	0.81 (1.78)	0.10 (2.36)

Primary outcome: Change in FMD in Response to Acute HIIT in the Untrained State

Time frame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise. Mean (Standard Deviation). Unit: % flow mediated dilation

Measure	Older Men n = 9	Older Postmenopausal Women n = 11
End of exercise	-0.46 (2.04)	0.19 (1.85)
1-hour post-exercise	-0.64 (1.97)	-1.28 (1.69)
24-hours post-exercise	-0.53 (1.18)	0.12 (1.93)

Primary outcome: Change in FMD in Response to Acute HIIT in the Trained State

Time frame: From pre-exercise to end of exercise; From pre-exercise to 1-hour post-exercise; From pre-exercise to 24-hours post-exercise. Mean (Standard Deviation). Unit: % flow mediated dilation

Measure	Older Men n = 9	Older Postmenopausal Women n = 11
End of exercise	0.77 (2.24)	-0.07 (2.32)
1-hour post-exercise	-0.66 (2.59)	-0.63 (2.15)
24-hours post-exercise	-0.45 (1.71)	1.35 (1.79)

Primary outcome: Correlation Coefficient for the Relationship Between Acute and Chronic FMD Response to HIIT

Time frame: Acute FMD response at 1) pre-exercise vs. end of exercise; 2) pre-exercise vs. 1-hour post-exercise; and 3) pre-exercise vs. 24-hours post-exercise. Chronic FMD response at baseline vs. end of 8-week. exercise intervention. Number. Unit: Correlation coefficient

Measure	Older Men n = 9	Older Postmenopausal Women n = 11
End of exercise	-0.32	-0.26
1-hour post-exercise	0	-0.20
24-hour post-exercise	-0.17	0.07

Adverse events

Time frame: Adverse event data were collected from study enrollment through study completion, an average of 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Older Men	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Older Postmenopausal Women	0 of 11 (0%)	8 of 11 (72.7%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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?

A study testing Exercise Period in people with 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 11 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 14 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 FMD in Response to Chronic HIIT (time frame: From baseline to end of 8-week control period; From end of 8-week control period to end of 8-week exercise intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04128215.

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 14 Nov 2024.