Exercise and Brain in Coronary Heart Disease

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: Two types of exercise interventions

• Registration Number: NCT06214624
• Lead Sponsor: Universidad de Granada

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.

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.

Study Timeline

• Study Start: 2022-04-19
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-19
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. 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)
2. Must have stable coronary heart disease (phase III), proven by invasive coronary angiography or CT with at least one coronary lesion > 50%.
3. Able to speak and read fluent Spanish.
4. Live in Granada city or surrounding areas (able to come to evaluations and exercise program)
5. Living in community during the study (i.e. independent home, non-assisted living facilities)
6. Ejection fraction ≥ 45%.
7. Functional grade I-II according to the New York Heart Association (NYHA) scale.
8. Sinus rhythm.
9. Stable optimal medical treatment (3 or more drugs at the determined by a cardiologist).
10. 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.
11. Classified as cognitively normal according to Stics-m

Exclusion Criteria

1. Used of assisted walking devices.
2. Acute coronary syndrome in the last year, coronary surgery, or percutaneous intervention in the last 6 months.
3. Treatment for any type of cancer in the last 2 years.
4. Severe hospitalization in the intensive care unit in the last 6 months.
5. 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).
6. Grade III obesity.
7. Diagnosis of neurological or cerebrovascular disorder (e.g. stroke).
8. Medical contraindication for inclusion in an exercise program.
9. Diabetes with uncontrolled glycemia.
10. Resting blood pressure > 180/110.
11. Chest pain with exertion or changes in the ST segment suggestive of severe ischemia during ergometry.
12. Severe inducible ischemia
13. Functional capacity in ergometry (<5 METS).
14. Obstructive left main artery disease (significant disease > 50%)
15. Unstable angina
16. Uncontrolled cardiac arrhythmia
17. Presence of metal implants (e.g., pacemaker or implantable cardioverter-defibrillator-ICD) not compatible with MRI (reported during the phone screening)
18. Paroxysmal or persistent atrial fibrillation with episodes in the last 6 months.
19. Moderate to severe pulmonary hypertension.
20. Acute endocarditis, myocarditis, or pericarditis.
21. Moderate to severe valve disease (grade 3-4)
22. Acute pulmonary embolism, or deep vein thrombosis.
23. Aortic dissection
24. High-grade heart block or complete left bundle branch block or altered basal electrocardiogram with difficulties to interpret in exercise testing.
25. Hypertrophic obstructive cardiomyopathy.
26. Retinopathy.
27. Severe autonomic or peripheral neuropathy.
28. Acute systemic illness or fever.
29. Acute or chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
30. Pulmonary fibrosis or interstitial disease (respiratory failure or severe COPD confirmed by pneumological study).
31. Recent treatment for alcohol or substance abuse.
32. Claustrophobia.
33. Any surgery or medical intervention planned during the study period.
34. Plans to participate or current participation in other studies that might interferes with this study.
35. Current pregnancy or intention to get pregnant during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-week aerobic HIIT plus resistance exercise program	Two types of exercise interventions	-
12-week of aerobic high-intensity interval training (HIIT) exercise program	Two types of exercise interventions	-

Primary Outcome Measures

Name	Time	Method
Change in cerebral blood flow	Baseline and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change cerebral vascularization	Baseline and 12 weeks	Cerebral vascularization will be measured using the magnetic resonance angiography TOF (Time-of-flight angiography).
Change in cardiorespiratory fitness	Baseline and 12 weeks	Cardiorespiratory fitness will be assessed by a cardiorespiratory exercise test in a treadmill measuring gas exchange (treadmill time-to-exhaustion and VO2peak)
Change in executive function and general cognition	Baseline and 12 weeks	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.

Trial Locations

Locations (1)

Sport and Health University Research Institute (iMUDS), Technological Health Park, University of Granada; 🇪🇸 Granada, Spain