Exercise and Brain in Coronary Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Two types of exercise interventions

Intervention Type 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

Group Type EXPERIMENTAL

Two types of exercise interventions

Intervention Type 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.

Usual care, Wait-list control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Two types of exercise interventions

* 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No