Status:
COMPLETED
Exercise and Brain in Coronary Heart Disease
Lead Sponsor:
Universidad de Granada
Collaborating Sponsors:
Instituto Mixto Universitario Deporte y Salud (iMUDS)
Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC)
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
50-75 years
Phase:
NA
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...
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 initiat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06214624
Start Date
April 19 2022
End Date
June 1 2024
Last Update
May 4 2025
Active Locations (1)
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1
Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada
Granada, Spain, 18007