Coronary Arterial Disease (CAD)NCT06617117
Central vs Brachial BP, Exercise, and Coronary Artery Disease
A study testing High-intensity combined exercise and Moderate-intensity combined exercise in people with Coronary Arterial Disease (CAD), run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
High blood pressure (BP) is a major risk factor for coronary artery disease (CAD), with 30-70% of CAD patients having elevated BP. The conventional method of measuring BP in the arm (brachial BP) may miss some cases, as individuals can have normal brachial pressure but elevated central systolic pressure, which is a… Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- High-intensity combined exercise and Moderate-intensity combined exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2018to 15 Mar 2020
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Middle-aged and older adults with stable coronary artery disease (over 55 years old)
- Aged-matched healthy adults free of cardiovascular, respiratory, or metabolic disease and with no more than 2 traditional risk factors.
- Physically active defined as engaging in exercise at least 3 times per week over the past 6 months
Who cannot join
- Cognitive impairment
- Pulmonary disease
- Uncontrolled atrial or ventricular dysrhythmia
- Disability or mental illness
- Extra-cardiac disease
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Motricidade Humana - University of Lisbon
Lisbon, Lisbon District, 1495-688
About this study
Official title: Dynamic Acute Responses of Different Intensity-dependent Exercises on the Autonomic and Vascular Systems in People With Coronary Artery Disease
High blood pressure (BP) is a major risk factor for coronary artery disease (CAD), with 30-70% of CAD patients having elevated BP. The conventional method of measuring BP in the arm (brachial BP) may miss some cases, as individuals can have normal brachial pressure but elevated central systolic pressure, which is a more critical predictor of cardiovascular events. Lowering BP is a key objective in cardiac rehabilitation programs.
Examining BP responses after a single bout of exercise could help predict how effectively exercise lowers BP over time. There is a well-established reduction in BP, known as post-exercise hypotension (PEH), which occurs after exercise. This drop is typically around 8 to 9 mmHg and is observed in individuals with and without hypertension. However, it may not occur in people with CAD. The reason for this difference is unclear but may relate to individual variability in exercise responses.
Read more
No research has closely examined individual responses to PEH in people with CAD, and it remains unclear whether exercise affects central and brachial BP differently, as some medications do. Additionally, exercise intensity may influence the magnitude of the BP reduction post-exercise. Higher-intensity exercise tends to cause a more significant BP drop, both in hypertensive and non-hypertensive individuals, typically within 20 to 60 minutes post-exercise.
Therefore, the present study aimed to determine the acute effects of combined exercise at different intensities on central and brachial blood pressure in individuals with and without coronary artery disease.
The key research questions were:
- Is the BP response of central and brachial arteries to acute combined exercise similar? How does coronary artery disease influence these BP responses? Is there individual variability among people with CAD?
- Does high-intensity exercise, compared to moderate-intensity exercise, produce more pronounced changes in BP in the post-acute exercise period?
All participants were asked to:
Complete two combined exercise sessions - one moderate- and one high-intensity bout. The order of the sessions was randomly assigned, similar to flipping a coin.
BP was measured before and after each acute exercise bout in the laboratory. The researchers compared central and brachial BP responses between exercise intensities (high vs. moderate) and populations (individuals with and without CAD).
Read the detailed description
This study was designed as a randomized cross-over, repeated measures experiment. All participants underwent two combined exercise sessions of varying intensities, specifically high (HIGH) and moderate (MOD), in a randomized sequence (http://www.randomizer.org/). Before the exercise sessions, all participants underwent both cardiopulmonary exercise testing and 1RM testing, followed by a DEXA scan during a subsequent visit to the laboratory. Each participant completed all experimental sessions consistently at the same time of the day, specifically in the mornings, with at least 48h between sessions to reduce diurnal variation. Post-exercise measurements were conducted at 5, 15 and 30 min after exercise. Participants reported to the laboratory in a fasted state (≥ 4h), and refrained from vigorous exercise, vitamin supplements, and foods/beverages containing caffeine and alcohol for at least 12 h preceding each experimental session.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- High-intensity combined exercise, Moderate-intensity combined exercise
- Keywords
- Central blood pressure, Brachial blood pressure, acute exercise, exercise intensity, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity combined exerciseOther
The main part consisted of interval cycling exercise, comprising 5x2 min at the second ventilatory threshold interspersed with 4x2 min at the first ventilatory threshold, followed by 2-min unloading pedalling. Subsequently, participants completed resistance exercises (2 sets of 12 repetitions), targeting the same muscle groups of the moderate-intensity exercise, at an intensity of 80% of their 1 repetition maximum.
Moderate-intensity combined exerciseOther
The main part of the exercise session consisted of an 18-min cycling continuous aerobic exercise at the first ventilatory threshold, followed by 2-min of unloading cycling. Subsequently, participants engaged in resistance exercises - 2 sets of 12 repetitions at 60% of their one repetition maximum. These resistance exercises were part of a machine-assisted circuit training program, encompassing Chest Press, Leg Curl, Low Row, Leg Press, Lat Pull-down, and Leg Extension.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity combined exercise | Experimental | A one-hour exercise session of moderate-intensity structured as follows: a warm-up (10 min), aerobic exercise (20 min), followed by a circuit resistance exercise (20 min), concluded with passive stretching cool down (10 min). Receives: Other: Moderate-intensity combined exercise |
| High-intensity combined exercise | Experimental | A one-hour exercise session of high-intensity structured as follows: a warm-up (10 min), aerobic exercise (20 min), followed by a circuit resistance exercise (20 min), concluded with passive stretching cool down (10 min). Receives: Other: High-intensity combined exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central blood pressure
Central systolic blood pressure (cSBP) was measured using non-invasive carotid tonometry (Complior, ALAM Medical) with participants in a supine position. Carotid waveforms were calibrated from brachial diastolic BP (bDBP) and mean arterial pressure (2/3 bDBP + 1/3 bSBP), assumed constant throughout the vascular system. A single operator performed 2 repeated measurements on the right side, each with 10 waveforms of higher than 90% quality, and the average was used. The pressure from wave reflection on SBP was derived as the difference between bSBP and cSBP.
Measured: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Brachial blood pressure
Brachial Blood pressure was measured in the supine position using an Omron sphygmomanometer after a 10-min rest. Hypertension was defined per ESH guidelines (bSBP ≥140 mmHg and/or bDBP ≥90 mmHg).
Measured: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Secondary outcomes (1)
Carotid femoral pulse wave velocity (cfPWV)
Central arterial stiffness was measured via carotid-femoral pulse wave velocity (cf PWV), wherein both carotid and femoral waveforms were collected simultaneously using piezoelectric pressure mechanotransducers (Complior, ALAM Medical, Paris, France). Pulse transit times (PTT) were automatically calculated using the intersect tangent algorithm of the foot-to-foot method, enabling the calculation of cfPWV as the ratio of distance to PTT. Travel time distances were defined as the taped measured distance over body surfaces between the two recording sites of interest, with the cf distance corrected by a factor of 0.8.
Measured: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Feb 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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 Coronary Arterial Disease (CAD)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel group crossover randomized trial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617117
- Sponsor's protocol ID
- BRAVE HEARTS
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained in this study may be provided to qualified researchers with an academic interest in vascular responses to exercise in people with coronary artery disease. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Iellamo F, Perrone MA, Caminiti G, Volterrani M, Legramante JM. Post-exercise Hypotension in Patients With Coronary Artery Disease. Front Physiol. 2021 Dec 22;12:788591. doi: 10.3389/fphys.2021.788591. eCollection 2021.
PubMed 35002770Kiviniemi AM, Hautala AJ, Karjalainen JJ, Piira OP, Lepojarvi S, Ukkola O, Huikuri HV, Tulppo MP. Acute post-exercise change in blood pressure and exercise training response in patients with coronary artery disease. Front Physiol. 2015 Jan 12;5:526. doi: 10.3389/fphys.2014.00526. eCollection 2014.
PubMed 25628572Fagard R, Vanhees L. Twenty-four hour blood pressure after exercise in patients with coronary artery disease. J Hum Hypertens. 2000 Apr;14(4):231-4. doi: 10.1038/sj.jhh.1000976.
PubMed 10805047Gaspar MP, Maroco JL, Cruz L, Laranjo S, Santa-Clara H, Fernhall B, Melo X. Repeatability of heart-rate variability and baroreflex sensitivity as metrics of cardiac autonomic function during exercise in young females and males. Eur J Appl Physiol. 2026 Mar;126(3):1479-1491. doi: 10.1007/s00421-025-06011-w. Epub 2025 Oct 25.
PubMed 41137920Maroco JL, Angarten V, Pinto R, Santos V, Fernhall B, Santa-Clara H, Melo X. Post-exercise differential response of central and brachial blood pressure in patients with coronary artery disease: A randomized crossover trial. PLoS One. 2025 Feb 21;20(2):e0317212. doi: 10.1371/journal.pone.0317212. eCollection 2025.
PubMed 39982938
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Acute Responses of Different Intensity-dependent Exercises on the Autonomic and Vascular Systems in People With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06617117
- Acronym / sponsor ID
- BRAVE HEARTS
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Central blood pressure, Brachial blood pressure, acute exercise, exercise intensity, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 27 Sep 2024 (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.
High blood pressure (BP) is a major risk factor for coronary artery disease (CAD), with 30-70% of CAD patients having elevated BP. The conventional method of measuring BP in the arm (brachial BP) may miss some cases, as individuals can have normal brachial pressure but elevated central systolic pressure, which is a more critical predictor of cardiovascular events. Lowering BP is a key objective in cardiac rehabilitation programs.
Examining BP responses after a single bout of exercise could help predict how effectively exercise lowers BP over time. There is a well-established reduction in BP, known as post-exercise hypotension (PEH), which occurs after exercise. This drop is typically around 8 to 9 mmHg and is observed in individuals with and without hypertension. However, it may not occur in people with CAD. The reason for this difference is unclear but may relate to individual variability in exercise responses.
No research has closely examined individual responses to PEH in people with CAD, and it remains unclear whether exercise affects central and brachial BP differently, as some medications do. Additionally, exercise intensity may influence the magnitude of the BP reduction post-exercise. Higher-intensity exercise tends to cause a more significant BP drop, both in hypertensive and non-hypertensive individuals, typically within 20 to 60 minutes post-exercise.
Therefore, the present study aimed to determine the acute effects of combined exercise at different intensities on central and brachial blood pressure in individuals with and without coronary artery disease.
The key research questions were:
- Is the BP response of central and brachial arteries to acute combined exercise similar? How does coronary artery disease influence these BP responses? Is there individual variability among people with CAD?
- Does high-intensity exercise, compared to moderate-intensity exercise, produce more pronounced changes in BP in the post-acute exercise period?
All participants were asked to:
Complete two combined exercise sessions - one moderate- and one high-intensity bout. The order of the sessions was randomly assigned, similar to flipping a coin.
BP was measured before and after each acute exercise bout in the laboratory. The researchers compared central and brachial BP responses between exercise intensities (high vs. moderate) and populations (individuals with and without CAD).
Detailed description
This study was designed as a randomized cross-over, repeated measures experiment. All participants underwent two combined exercise sessions of varying intensities, specifically high (HIGH) and moderate (MOD), in a randomized sequence (http://www.randomizer.org/). Before the exercise sessions, all participants underwent both cardiopulmonary exercise testing and 1RM testing, followed by a DEXA scan during a subsequent visit to the laboratory. Each participant completed all experimental sessions consistently at the same time of the day, specifically in the mornings, with at least 48h between sessions to reduce diurnal variation. Post-exercise measurements were conducted at 5, 15 and 30 min after exercise. Participants reported to the laboratory in a fasted state (≥ 4h), and refrained from vigorous exercise, vitamin supplements, and foods/beverages containing caffeine and alcohol for at least 12 h preceding each experimental session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity combined exercise | Experimental | Other: Moderate-intensity combined exerciseA one-hour exercise session of moderate-intensity structured as follows: a warm-up (10 min), aerobic exercise (20 min), followed by a circuit resistance exercise (20 min), concluded with passive stretching cool down (10 min). |
| High-intensity combined exercise | Experimental | Other: High-intensity combined exerciseA one-hour exercise session of high-intensity structured as follows: a warm-up (10 min), aerobic exercise (20 min), followed by a circuit resistance exercise (20 min), concluded with passive stretching cool down (10 min). |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Middle-aged and older adults with stable coronary artery disease (over 55 years old)
- Aged-matched healthy adults free of cardiovascular, respiratory, or metabolic disease and with no more than 2 traditional risk factors.
- Physically active defined as engaging in exercise at least 3 times per week over the past 6 months
Key exclusion criteria (5 listed)
- Cognitive impairment
- Pulmonary disease
- Uncontrolled atrial or ventricular dysrhythmia
- Disability or mental illness
- Extra-cardiac disease
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 |
|---|---|---|
| High-intensity combined exerciseThe main part consisted of interval cycling exercise, comprising 5x2 min at the second ventilatory threshold interspersed with 4x2 min at the first ventilatory threshold, followed by 2-min unloading pedalling. Subsequently, participants completed resistance exercises (2 sets of 12 repetitions), targeting the same muscle groups of the moderate-intensity exercise, at an intensity of 80% of their 1 repetition maximum. | Other | High-intensity combined exercise |
| Moderate-intensity combined exerciseThe main part of the exercise session consisted of an 18-min cycling continuous aerobic exercise at the first ventilatory threshold, followed by 2-min of unloading cycling. Subsequently, participants engaged in resistance exercises - 2 sets of 12 repetitions at 60% of their one repetition maximum. These resistance exercises were part of a machine-assisted circuit training program, encompassing Chest Press, Leg Curl, Low Row, Leg Press, Lat Pull-down, and Leg Extension. | Other | Moderate-intensity combined exercise |
Primary outcome
Central blood pressure
Time frame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Central systolic blood pressure (cSBP) was measured using non-invasive carotid tonometry (Complior, ALAM Medical) with participants in a supine position. Carotid waveforms were calibrated from brachial diastolic BP (bDBP) and mean arterial pressure (2/3 bDBP + 1/3 bSBP), assumed constant throughout the vascular system. A single operator performed 2 repeated measurements on the right side, each with 10 waveforms of higher than 90% quality, and the average was used. The pressure from wave reflection on SBP was derived as the difference between bSBP and cSBP.
Brachial blood pressure
Time frame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Brachial Blood pressure was measured in the supine position using an Omron sphygmomanometer after a 10-min rest. Hypertension was defined per ESH guidelines (bSBP ≥140 mmHg and/or bDBP ≥90 mmHg).
1 secondary outcome
Carotid femoral pulse wave velocity (cfPWV)
Time frame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined 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 27 Sep 2024.
- Results publication: PubMed 35002770Iellamo F, Perrone MA, Caminiti G, Volterrani M, Legramante JM. Post-exercise Hypotension in Patients With Coronary Artery Disease. Front Physiol. 2021 Dec 22;12:788591. doi: 10.3389/fphys.2021.788591. eCollection 2021.
- Results publication: PubMed 25628572Kiviniemi AM, Hautala AJ, Karjalainen JJ, Piira OP, Lepojarvi S, Ukkola O, Huikuri HV, Tulppo MP. Acute post-exercise change in blood pressure and exercise training response in patients with coronary artery disease. Front Physiol. 2015 Jan 12;5:526. doi: 10.3389/fphys.2014.00526. eCollection 2014.
- Results publication: PubMed 10805047Fagard R, Vanhees L. Twenty-four hour blood pressure after exercise in patients with coronary artery disease. J Hum Hypertens. 2000 Apr;14(4):231-4. doi: 10.1038/sj.jhh.1000976.
- Derived from this study: PubMed 41137920Gaspar MP, Maroco JL, Cruz L, Laranjo S, Santa-Clara H, Fernhall B, Melo X. Repeatability of heart-rate variability and baroreflex sensitivity as metrics of cardiac autonomic function during exercise in young females and males. Eur J Appl Physiol. 2026 Mar;126(3):1479-1491. doi: 10.1007/s00421-025-06011-w. Epub 2025 Oct 25.
- Derived from this study: PubMed 39982938Maroco JL, Angarten V, Pinto R, Santos V, Fernhall B, Santa-Clara H, Melo X. Post-exercise differential response of central and brachial blood pressure in patients with coronary artery disease: A randomized crossover trial. PLoS One. 2025 Feb 21;20(2):e0317212. doi: 10.1371/journal.pone.0317212. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data obtained in this study may be provided to qualified researchers with an academic interest in vascular responses to exercise in people with coronary artery disease. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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 High-intensity combined exercise and Moderate-intensity combined exercise in people with Coronary Arterial Disease (CAD), run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 5 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 27 Sep 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 Portugal. 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?
Central blood pressure (time frame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise). 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 NCT06617117, 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 27 Sep 2024.