Central Vs Brachial BP, Exercise, and Coronary Artery Disease

NCT ID: NCT06617117

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-03-15

Brief Summary

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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

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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

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Coronary Arterial Disease (CAD)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Parallel group crossover randomized trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

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.

Study Groups

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Moderate-intensity combined exercise

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).

Group Type EXPERIMENTAL

Moderate-intensity combined exercise

Intervention Type 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.

High-intensity combined exercise

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).

Group Type EXPERIMENTAL

High-intensity combined exercise

Intervention Type 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.

Interventions

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High-intensity combined exercise

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.

Intervention Type OTHER

Moderate-intensity combined exercise

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculdade de Motricidade Humana - University of Lisbon

Lisbon, Lisbon District, Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type BACKGROUND
PMID: 35002770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25628572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10805047 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41137920 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39982938 (View on PubMed)

Other Identifiers

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BRAVE HEARTS

Identifier Type: -

Identifier Source: org_study_id