Clinical trial NCT06617117: Central Vs Brachial BP, Exercise, and Coronary Artery Disease
Official title: Dynamic Acute Responses of Different Intensity-dependent Exercises on the Autonomic and Vascular Systems in People with Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Keywords: Central blood pressure
Brachial blood pressure
acute exercise
exercise intensity
coronary artery disease
Lead sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 35
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parallel group crossover randomized trial
Primary purpose: OTHER

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. 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. 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.

Eligibility criteria: Inclusion criteria for the coronary artery disease group:

* Middle-aged and older adults with stable coronary artery disease (over 55 years old)

Inclusion criteria for the control group:

* 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

Exclusion criteria for both groups:

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

Primary outcomes:
measure: Central blood pressure
timeFrame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
measure: Brachial blood pressure
timeFrame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Secondary outcomes:
measure: Carotid femoral pulse wave velocity (cfPWV)
timeFrame: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Faculdade de Motricidade Humana - University of Lisbon
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.