Central Vs Brachial BP, Exercise, and Coronary Artery Disease

NCT06617117 | Completed

• 1 other identifier: BRAVE HEARTS
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.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?
2. 2.Does high-intensity exercise, compared to moderate-intensity exercise, produce more pronounced changes in BP in the post-acute exercise period?

Conditions

Coronary Arterial Disease (CAD)

Keywords

Central blood pressure; Brachial blood pressure; acute exercise; exercise intensity; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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)

  Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise

Study Arms (2)

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).

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).

Other: High-intensity combined exercise

Interventions

High-intensity combined exercise OTHER

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.

High-intensity combined exercise

Moderate-intensity combined exercise OTHER

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.

Moderate-intensity combined exercise

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment
• Pulmonary disease
• Uncontrolled atrial or ventricular dysrhythmia
• Disability or mental illness
• Extra-cardiac disease

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Faculdade de Motricidade Humana - University of Lisbon

Lisbon, Lisbon District, 1495-688, Portugal

Location

Related Publications (5)

• 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.

  PMID: 35002770 BACKGROUND

• Kiviniemi 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.

  PMID: 25628572 BACKGROUND

• Fagard 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.

  PMID: 10805047 BACKGROUND

• Gaspar 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. 2025 Oct 25. doi: 10.1007/s00421-025-06011-w. Online ahead of print.

  PMID: 41137920 DERIVED

• Maroco 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.

  PMID: 39982938 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes will be assessed by the same experts in every time point. Participants and evaluators will be blinded until arrival of the participant for the first experimental condition.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group crossover randomized trial

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: February 1, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

Locations

PT (1)