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NCT06214624Completed

Exercise and Brain in Coronary Heart Disease

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

Source: ClinicalTrials.gov · Last updated 4 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
96 (actual)
First submitted
22 Dec 2023
Start date
Apr 2022
Primary completion date
Jun 2024
Lead sponsor
Universidad de Granada
NCT number
NCT06214624

What you commit to

  • Study type: Interventional
  • Participants enrolled: 96
  • From Apr 2022 to the primary completion date, Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of metal implants (e.g., pacemaker or implantable cardioverter-defibrillator-ICD) not compatible with MRI (reported during the phone screening)
  • Any surgery or medical intervention planned during the study period.

Other illness

  • 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.
  • 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).
  • Diagnosis of neurological or cerebrovascular disorder (e.g. stroke).
  • Diabetes with uncontrolled glycemia.
  • Obstructive left main artery disease (significant disease \> 50%)
  • Unstable angina
  • Uncontrolled cardiac arrhythmia
  • Moderate to severe pulmonary hypertension.
  • Moderate to severe valve disease (grade 3-4)
  • Acute pulmonary embolism, or deep vein thrombosis.
  • High-grade heart block or complete left bundle branch block or altered basal electrocardiogram with difficulties to interpret in exercise testing.
  • 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).

Other

  • Used of assisted walking devices.
  • Severe hospitalization in the intensive care unit in the last 6 months.
  • Grade III obesity.
  • Medical contraindication for inclusion in an exercise program.
  • 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).
  • Paroxysmal or persistent atrial fibrillation with episodes in the last 6 months.
  • Acute endocarditis, myocarditis, or pericarditis.
  • Aortic dissection
  • Hypertrophic obstructive cardiomyopathy.
  • Retinopathy.
  • Severe autonomic or peripheral neuropathy.
  • Recent treatment for alcohol or substance abuse.
  • Claustrophobia.
  • 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

Who the study is looking for

  • 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).
  • 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

Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada
Coordinator of this site? Confirm its status
GranadaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.