Exercise and Brain in Coronary Heart Disease

NCT06214624 | Completed

• 1 other identifier: 1776-N21
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The Heart-Brain project is a randomized controlled trial designed to examine the effects of two different exercise programs of 12-week duration: 1) aerobic high intensity interval training (HIIT), and 2) aerobic HIIT plus resistance training, on brain health and other outcomes in coronary heart disease patients.

Conditions

Coronary Heart Disease

Keywords

coronary artery disease; ischemic heart disease; exercise; HIIT; resistance training; brain; cognition; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change in cerebral blood flow

  The main outcome is the change in global cerebral blood flow from baseline to 12 weeks. Cerebral blood flow will be measured using the magnetic resonance imaging technique of TGSE-pCASL (turbo gradient spin echo-pseudo continuous arterial spin labeling). Additionally, regional cerebral blood flow will be determined in a voxel-wise analysis to measure local perfusion.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Change cerebral vascularization

  Baseline and 12 weeks

• Change in executive function and general cognition

  Baseline and 12 weeks

• Change in cardiorespiratory fitness

  Baseline and 12 weeks

Other Outcomes (37)

• Change in blood brain barrier (BBB) permeability

  Baseline and 12 weeks

• Change in brain morphology

  Baseline and 12 weeks

• Change in white matter structure

  Baseline and 12 weeks

Study Arms (3)

12-week of aerobic high-intensity interval training (HIIT) exercise program

EXPERIMENTAL

Behavioral: Two types of exercise interventions

12-week aerobic HIIT plus resistance exercise program

EXPERIMENTAL

Behavioral: Two types of exercise interventions

Usual care, Wait-list control group

NO INTERVENTION

The control group (as well as the 2 intervention groups) will be treated as usual in outpatient Phase III, which in Spain includes periodic medical revisions and medication control. In addition, for the control group, we will apply the wait-list strategy providing the supervised exercise program once all data collection for pre- and post-intervention assessment points have been finished.

Interventions

Two types of exercise interventions BEHAVIORAL

* HIIT. 3 times/week. This consists of a 4x4 HIIT (preferably in treadmill), 4 intervals of 4min at high intensity (85-95% HRmax) and 3 intervals of 3min of active resting at \~70% HRmax in between. All sessions including 10 min of warming-up and 10min of cooling down, resulting in 45min sessions. The first 2 weeks will progress from moderate-intensity training to HIIT for a better adaptation and acceptability of the program. * HIIT + resistance. 3 times/week. The aerobic part consists of a 3x4 HIIT (preferably in treadmill), 3 intervals of 4min at high intensity (85-95% HRmax) and 2 intervals of 3min of active resting (\~70% HRmax) in between. The resistance part consists of 2 series of an 8-exercise circuit (combination of upper and lower body exercises using elastic bands and body weight) with a ratio of 20sec of effort - 40sec of resting. Sessions will have 5min of warming up in the treadmill and 5min of cooling down walking in the gym, comprising a total of 45min sessions.

12-week aerobic HIIT plus resistance exercise program; 12-week of aerobic high-intensity interval training (HIIT) exercise program

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 50 and 75 years old, both inclusive (\*Contingency plan: increase the range to 40-75 if we have difficulties to get the study sample)
• Must have stable coronary heart disease (phase III), proven by invasive coronary angiography or CT with at least one coronary lesion \> 50%.
• Able to speak and read fluent Spanish.
• Live in Granada city or surrounding areas (able to come to evaluations and exercise program)
• Living in community during the study (i.e. independent home, non-assisted living facilities)
• Ejection fraction ≥ 45%.
• Functional grade I-II according to the New York Heart Association (NYHA) scale.
• Sinus rhythm.
• Stable optimal medical treatment (3 or more drugs at the determined by a cardiologist).
• Classified as cognitively normal according to Stics-m

You may not qualify if:

• Used of assisted walking devices.
• Acute coronary syndrome in the last year, coronary surgery, or percutaneous intervention in the last 6 months.
• Treatment for any type of cancer in the last 2 years.
• Severe hospitalization in the intensive care unit in the last 6 months.
• Current psychiatric diagnosis (visit to psychiatrist and drug treatment prescription in the last year), including major depression and history of psychiatric illness (schizophrenia, bipolar disorder, hallucinations).
• Grade III obesity.
• Diagnosis of neurological or cerebrovascular disorder (e.g. stroke).
• Diabetes with uncontrolled glycemia.
• Resting blood pressure \> 180/110.
• Chest pain with exertion or changes in the ST segment suggestive of severe ischemia during ergometry.
• Severe inducible ischemia
• Functional capacity in ergometry (\<5 METS).
• Obstructive left main artery disease (significant disease \> 50%)
• Unstable angina
• Uncontrolled cardiac arrhythmia

Sponsors & Collaborators

• Universidad de Granada: lead
• Instituto Mixto Universitario Deporte y Salud (iMUDS): collaborator
• Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC): collaborator
• University Hospital Virgen de las Nieves: collaborator
• Hospital Clinico Universitario San Cecilio: collaborator
• Centro de Investigación Biomédica en Red de la Fisiopatología de la Obesidad y Nutrición (CIBEROBN): collaborator

Study Sites (1)

Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada

Granada, 18007, Spain

Location

Related Publications (2)

• Toval A, Solis-Urra P, Bakker EA, Sanchez-Aranda L, Fernandez-Ortega J, Prieto C, Alonso-Cuenca RM, Gonzalez-Garcia A, Martin-Fuentes I, Fernandez-Gamez B, Olvera-Rojas M, Coca-Pulido A, Bellon D, Sclafani A, Sanchez-Martinez J, Rivera-Lopez R, Herrera-Gomez N, Penafiel-Burkhardt R, Lopez-Espinosa V, Corpas-Perez S, Garcia-Ortega MB, Vega-Cordoba A, Barranco-Moreno EJ, Morales-Navarro FJ, Nieves R, Caro-Rus A, Amaro-Gahete FJ, Mora-Gonzalez J, Vidal-Almela S, Carlen A, Migueles JH, Erickson KI, Moreno-Escobar E, Garcia-Orta R, Esteban-Cornejo I, Ortega FB. Exercise and brain health in patients with coronary artery disease: study protocol for the HEART-BRAIN randomized controlled trial. Front Aging Neurosci. 2024 Aug 23;16:1437567. doi: 10.3389/fnagi.2024.1437567. eCollection 2024.

  PMID: 39246594 BACKGROUND

• Toval A, Bakker EA, Granada-Maia JB, Nunez de Arenas-Arroyo S, Solis-Urra P, Eijsvogels TMH, Esteban-Cornejo I, Martinez-Vizcaino V, Ortega FB. Exercise type and settings, quality of life, and mental health in coronary artery disease: a network meta-analysis. Eur Heart J. 2025 Jun 16;46(23):2186-2201. doi: 10.1093/eurheartj/ehae870.

  PMID: 39809303 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Behavior

Study Officials

• Francisco B Ortega, Professor

  Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 19, 2024
• Study Start: April 19, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD data will be available 12 months after the primary outcome paper published. The data will be available 15 years after data collection.
• Access Criteria: The specific process of data access will be determined in a later stage, but in general the research team supports data sharing. Roughly, data will be available upon reasonable request to the PI (FB Ortega). The data requests must contain the purpose and aim of the research, but also specification of the data requested, and data analysis before data sharing. Data will only be shared for research purposes on exercise, cardiovascular and brain health. In addition, we will follow "as open as possible, as closed as necessary" principle, so depending on this principle we will decide whether the data could be shared. A data access committee will be installed to approve data requests.

Locations

ES (1)