HemodynamicNCT03080636
Sex and Exercise-mode Differences in Post Exercise Blood Pressure and Heart Rate Variability Responses During Workday
A study testing Aerobic exercise and Resistance exercise in people with Hemodynamic and Exercise, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The present study compared the acute effects of Sex and exercise mode on subsequent blood pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults. All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym and a seated control session. Read more about this study
- Who is it for?
- Ages 28 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic, Exercise
- What is being tested?
- Aerobic exercise and Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2014to 20 Feb 2015
- Phase
- Interventional
- 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 28 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to practice aerobic and resistance exercise at moderate intensity;
- Men and women;
- Normotensive, pre-hypertensive or hypertensive stage 1.
Who cannot join
- Renal pathologies;
- Using beta blockers;
- History of stroke or acute myocardial infarction;
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
The present study compared the acute effects of Sex and exercise mode on subsequent blood pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults. All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym and a seated control session.
Read the detailed description
Resting blood pressure and heart rate variability are simple and non-invasive methods to evaluate cardiovascular risk after different exercise sessions. Thus, exercise can reduce these risk factors in the short and long term, but these responses can be different between sex in different exercise sessions.
- Conditions
- Hemodynamic, Exercise
- Being tested
- Aerobic exercise, Resistance exercise, Control session
- Keywords
- Post-exercise hypotension, Aerobic Exercise, Resistance Exercise, Autonomic Stress, Heart Rate Variability, Sex difference
- Medical subject headings
- Motor Activity, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
30 minutes of treadmill exercise at 60-70% of heart rate reserve
Resistance exerciseOther
30 minutes of circuit resistance session at 40% of 1 maximun repetition test
Control sessionOther
30 minutes seated resting
| Study group | Role | What they receive |
|---|---|---|
| Men | Experimental | 11 men randomly underwent three experimental sessions in early morning prior to their work routine. Receives: Other: Aerobic exercise; Other: Resistance exercise; Other: Control session |
| Women | Experimental | 9 women randomly underwent three experimental sessions in early morning prior to their work routine. Receives: Other: Aerobic exercise; Other: Resistance exercise; Other: Control session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting blood pressure
During all sessions, systolic (SBP) and diastolic blood pressure (DBP) were triplicate measured by an automatic blood pressure analyzer after rest in seated position.
Measured: Change from baseline Systolic and Diastolic Blood Pressure to 15, 30, 45, 60, 210, 360 and 540 minutes after exercise/control session
Heart Rate Variability
The HR was recorded by a heart rate monitor (sampling frequency = 1000Hz) in a beat-by-beat basis. HR was registered in a seat position during 15 minutes for each measure.
Measured: Change from baseline Heart Rate Variability components to 15, 30, 45 and 60 minutes after exercise/control session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Jan 2014
- Primary completion24 Dec 2014
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemodynamicStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 20 healthy adults, public servants (9W and 11M), randomly underwent three experimental sessions in early morning prior to their work routine: a circuit resistance session at 40% of 1RM, a treadmill exercise session at 60-70% of heart rate reserve and a resting control session.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Moraes Mariano, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080636
- Sponsor's protocol ID
- CAAE: 28174814.9.0000.5152
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gomes Anunciacao P, Doederlein Polito M. A review on post-exercise hypotension in hypertensive individuals. Arq Bras Cardiol. 2011 May;96(5):e100-109. Epub 2011 Mar 4. English, Portuguese, Spanish.
PubMed 21359479Halliwill JR, Buck TM, Lacewell AN, Romero SA. Postexercise hypotension and sustained postexercise vasodilatation: what happens after we exercise? Exp Physiol. 2013 Jan;98(1):7-18. doi: 10.1113/expphysiol.2011.058065. Epub 2012 Aug 7.
PubMed 22872658Queiroz AC, Rezk CC, Teixeira L, Tinucci T, Mion D, Forjaz CL. Gender influence on post-resistance exercise hypotension and hemodynamics. Int J Sports Med. 2013 Nov;34(11):939-44. doi: 10.1055/s-0033-1337948. Epub 2013 Apr 19.
PubMed 23606339Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
PubMed 8737210Cote AT, Bredin SS, Phillips AA, Koehle MS, Warburton DE. Greater autonomic modulation during post-exercise hypotension following high-intensity interval exercise in endurance-trained men and women. Eur J Appl Physiol. 2015 Jan;115(1):81-9. doi: 10.1007/s00421-014-2996-5. Epub 2014 Sep 11.
PubMed 25208772
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex and Exercise-mode Differences in Post Exercise Blood Pressure and Heart Rate Variability Responses During Workday
- ClinicalTrials.gov ID
- NCT03080636
- Acronym / sponsor ID
- CAAE: 28174814.9.0000.5152
- Conditions
- Hemodynamic, Exercise
- Keywords
- Post-exercise hypotension, Aerobic Exercise, Resistance Exercise, Autonomic Stress, Heart Rate Variability, Sex difference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 24 Dec 2014 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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 present study compared the acute effects of Sex and exercise mode on subsequent blood pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults. All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym and a seated control session.
Detailed description
Resting blood pressure and heart rate variability are simple and non-invasive methods to evaluate cardiovascular risk after different exercise sessions. Thus, exercise can reduce these risk factors in the short and long term, but these responses can be different between sex in different exercise sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 healthy adults, public servants (9W and 11M), randomly underwent three experimental sessions in early morning prior to their work routine: a circuit resistance session at 40% of 1RM, a treadmill exercise session at 60-70% of heart rate reserve and a resting control session.
| Arm | Type | Receives |
|---|---|---|
| Men | Experimental | Other: Aerobic exercise, Other: Resistance exercise, Other: Control session11 men randomly underwent three experimental sessions in early morning prior to their work routine. |
| Women | Experimental | Other: Aerobic exercise, Other: Resistance exercise, Other: Control session9 women randomly underwent three experimental sessions in early morning prior to their work routine. |
Who may qualify
- Ages
- 28 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to practice aerobic and resistance exercise at moderate intensity;
- Men and women;
- Normotensive, pre-hypertensive or hypertensive stage 1.
Key exclusion criteria (4 listed)
- Renal pathologies;
- Using beta blockers;
- History of stroke or acute myocardial infarction;
- Smokers.
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 |
|---|---|---|
| Aerobic exercise30 minutes of treadmill exercise at 60-70% of heart rate reserve | Other | Men, Women |
| Resistance exercise30 minutes of circuit resistance session at 40% of 1 maximun repetition test | Other | Men, Women |
| Control session30 minutes seated resting | Other | Men, Women |
Primary outcome
Resting blood pressure
Time frame: Change from baseline Systolic and Diastolic Blood Pressure to 15, 30, 45, 60, 210, 360 and 540 minutes after exercise/control session
During all sessions, systolic (SBP) and diastolic blood pressure (DBP) were triplicate measured by an automatic blood pressure analyzer after rest in seated position.
Heart Rate Variability
Time frame: Change from baseline Heart Rate Variability components to 15, 30, 45 and 60 minutes after exercise/control session
The HR was recorded by a heart rate monitor (sampling frequency = 1000Hz) in a beat-by-beat basis. HR was registered in a seat position during 15 minutes for each measure.
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 15 Mar 2017.
- Background: PubMed 21359479Gomes Anunciacao P, Doederlein Polito M. A review on post-exercise hypotension in hypertensive individuals. Arq Bras Cardiol. 2011 May;96(5):e100-109. Epub 2011 Mar 4. English, Portuguese, Spanish.
- Background: PubMed 22872658Halliwill JR, Buck TM, Lacewell AN, Romero SA. Postexercise hypotension and sustained postexercise vasodilatation: what happens after we exercise? Exp Physiol. 2013 Jan;98(1):7-18. doi: 10.1113/expphysiol.2011.058065. Epub 2012 Aug 7.
- Background: PubMed 23606339Queiroz AC, Rezk CC, Teixeira L, Tinucci T, Mion D, Forjaz CL. Gender influence on post-resistance exercise hypotension and hemodynamics. Int J Sports Med. 2013 Nov;34(11):939-44. doi: 10.1055/s-0033-1337948. Epub 2013 Apr 19.
- Background: PubMed 8737210Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
- Background: PubMed 25208772Cote AT, Bredin SS, Phillips AA, Koehle MS, Warburton DE. Greater autonomic modulation during post-exercise hypotension following high-intensity interval exercise in endurance-trained men and women. Eur J Appl Physiol. 2015 Jan;115(1):81-9. doi: 10.1007/s00421-014-2996-5. Epub 2014 Sep 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Resistance exercise in people with Hemodynamic and Exercise, run by Federal University of Uberlandia at 1 site in Brazil.
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 3 inclusion and 4 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 15 Mar 2017. 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 Brazil. 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?
Resting blood pressure (time frame: Change from baseline Systolic and Diastolic Blood Pressure to 15, 30, 45, 60, 210, 360 and 540 minutes after exercise/control session). The study lists 2 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 NCT03080636, which also lists 5 linked publications.
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 15 Mar 2017.