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Coronary Heart DiseaseHeart-BrainNCT06214624

Exercise and Brain in Coronary Heart Disease

A study testing Two types of exercise interventions in people with Coronary Heart Disease, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
Two types of exercise interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteSpain
Study dates
19 Apr 2022to 1 Jun 2024
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
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  • 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).
  • Physically inactive, considering: 1) not meeting the WHO recommendations in both the aerobic and strength part, and 2) not to be participating in a planned and structured exercise program at least 3 days per week and for more than 3 months. Both conditions must be met to be included. Note: going for a walk will not be considered an exclusion reason.
  • Classified as cognitively normal according to Stics-m

Who cannot join

  • 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.
Show all 35Show fewer
  • Diagnosis of neurological or cerebrovascular disorder (e.g. stroke).
  • Medical contraindication for inclusion in an exercise program.
  • 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
  • Presence of metal implants (e.g., pacemaker or implantable cardioverter-defibrillator-ICD) not compatible with MRI (reported during the phone screening)
  • Paroxysmal or persistent atrial fibrillation with episodes in the last 6 months.
  • Moderate to severe pulmonary hypertension.
  • Acute endocarditis, myocarditis, or pericarditis.
  • Moderate to severe valve disease (grade 3-4)
  • Acute pulmonary embolism, or deep vein thrombosis.
  • Aortic dissection
  • High-grade heart block or complete left bundle branch block or altered basal electrocardiogram with difficulties to interpret in exercise testing.
  • Hypertrophic obstructive cardiomyopathy.
  • Retinopathy.
  • Severe autonomic or peripheral neuropathy.
  • Acute systemic illness or fever.
  • Acute or chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
  • Pulmonary fibrosis or interstitial disease (respiratory failure or severe COPD confirmed by pneumological study).
  • Recent treatment for alcohol or substance abuse.
  • Claustrophobia.
  • Any surgery or medical intervention planned during the study period.
  • Plans to participate or current participation in other studies that might interferes with this study.
  • Current pregnancy or intention to get pregnant during the study period

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Granada, 18007

Other trials in Spain

About this study

Official title: Effects of Exercise on Brain Health in Patients With Coronary Heart Disease: the Heart-Brain Randomized Controlled Trial

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.

Read the detailed description

Patients with coronary heart disease (CHD) has higher risk of developing dementia, cognitive impairment, and mental disorders. There is, therefore, a need to identify effective and sustainable initiatives to avoid or attenuate cognitive and mental health declines in these patients, and in this context, physical exercise can play a major role. The overall objective of the present project is to investigate the effects of exercise on brain health outcomes in CHD patients. The Heart-Brain project is a single-blinded, exercise-based randomized controlled trial. We will run a three-arms trial with a waiting-list control group, and two intervention groups that will receive two different supervised exercise programs: 1) aerobic high intensity interval training (HIIT) and 2) a combination of aerobic HIIT plus resistance training. The study will be conducted in 90 patients with CHD who meet the eligibility criteria indicated below.

Being tested
Two types of exercise interventions
Keywords
coronary artery disease, ischemic heart disease, exercise, HIIT, resistance training, brain, cognition, magnetic resonance imaging
Medical subject headings
Coronary Disease, Coronary Artery Disease, Myocardial Ischemia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Two types of exercise interventionsBehavioural

    • 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.
Study groups in NCT06214624
Study groupRoleWhat they receive
12-week of aerobic high-intensity interval training (HIIT) exercise programExperimentalNot described
Receives: Behavioral: Two types of exercise interventions
12-week aerobic HIIT plus resistance exercise programExperimentalNot described
Receives: Behavioral: Two types of exercise interventions
Usual care, Wait-list control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 12 weeks

Secondary outcomes (3)

  1. Change cerebral vascularization

    Cerebral vascularization will be measured using the magnetic resonance angiography TOF (Time-of-flight angiography).

    Measured: Baseline and 12 weeks

  2. Change in executive function and general cognition

    A comprehensive neuropsychological battery will assess several domains of executive function: working memory, cognitive flexibility and inhibitory control, and an executive function score will be computed and used as main behavioral outcome . Additionally, the general cognition will be assessed by the MOCA (MONTREAL COGNITIVE ASSESSMENT) test.

    Measured: Baseline and 12 weeks

  3. Change in cardiorespiratory fitness

    Cardiorespiratory fitness will be assessed by a cardiorespiratory exercise test in a treadmill measuring gas exchange (treadmill time-to-exhaustion and VO2peak)

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start19 Apr 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214624
Sponsor's protocol ID
1776-N21
Acronym
Heart-Brain
Status last verified
Apr 2025
First submitted
22 Dec 2023
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The protocol, statistical analyses plan and data management plan will be share open access. Data files including IPD, and corresponding data dictionaries, will be shared under restricted access and upon reasonable request (contact FB Ortega) due to privacy issue and GDPR regulations. In principle, all collected IPD will be available for sharing under the "as open as possible, as closed as necessary" principle. The shared data files will be pseudonymized, only include participants who provided informed consent for sharing, and sharing is only possible when the data is used for research purposes regarding exercise, and cardiovascular and brain health. This is stated at the informed consent files that the participants signed when they agree to participate

Publications

  • 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.

    PubMed 39246594

  • 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.

    PubMed 39809303

Questions about this trial

What is this clinical trial studying?

A study testing Two types of exercise interventions in people with Coronary Heart Disease, run by Universidad de Granada at 1 site in Spain.

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 11 inclusion and 35 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 4 May 2025. 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 Spain. 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?

Change in cerebral blood flow (time frame: Baseline and 12 weeks). 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 NCT06214624, which also lists 2 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 4 May 2025.

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