Effect of an Aerobic Exercise Session on Cardiovascular and Autonomic Parameters of Adults With Hypertrophic Cardiomyopathy

NCT07127640 | Active Not Recruiting

• 1 other identifier: UP 6126/24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in young individuals, often without symptoms. Due to the higher cardiovascular risk described for individuals with hypertrophic cardiomyopathy, it is extremely important to create non-pharmacological strategies that can minimize the evolution of cardiovascular risk factors found in this population. The objective of the study will be to evaluate the effect of an aerobic exercise session on the ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability, endothelial function through flow-mediated dilation and systolic and diastolic blood pressure during the 24-hour period in adult individuals with hypertrophic cardiomyopathy. The study design will be a randomized crossover clinical trial with individuals aged 18 to 59 years, of both sexes, randomized by lottery and divided into two groups: Exercise group and control group without exercise. An exercise stress test will be performed and on a new date the individuals will perform a supervised session of moderate-intensity aerobic exercise on a horizontal stationary bicycle for 50 minutes or will remain seated in an air-conditioned room for the same period of time. Subsequently, the procedures will be crossed. It is expected to find improvements in the parameters of endothelial function, autonomic modulation and 24-hour blood pressure in adult individuals with non-obstructive hypertrophic cardiomyopathy undergoing a session of aerobic physical exercise when compared to a control session without exercise.

Conditions

Cardiomyopathy, Hypertrophic; Physical Exercise; Autonomic Nervous System; Endothelium; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Assessment of autonomic system function

  Ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability by electrocardiogram

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

• Assessment of endothelial function

  From enrollment to the end of treatment at 2 weeks

• Blood pressure assessment

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.

Other: Exercise

Control

NO INTERVENTION

The control session will consist of the individual remaining seated for 50 minutes in an air-conditioned room.

Interventions

Exercise OTHER

An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.

Exercise

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The study population will consist of individuals aged between 18 and 59 years with HCM diagnosed via ICFUC medical records.

You may not qualify if:

• Individuals with a history of exercise-induced arrhythmias, a history of aborted sudden death, and the presence of an implantable cardioverter defibrillator will be excluded from the sample. Those with LVOT obstruction at rest ≥50 mmHg on medical therapy, recent septal reduction therapy, pregnancy, class IV symptoms in the New York Heart Association (NYHA) functional classification78, hypotensive response to exercise (drop in systolic BP \>20 mmHg in relation to the resting value or during exercise) will also be excluded. Concomitantly, those with systolic dysfunction of left ventricular ejection fraction \<50%, myocardial infarction, or previous stroke will be excluded. Hypertensive patients, those with orthopedic limitations, or any physical or mental limitation that prevents them from performing physical exercises will also be excluded.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia do Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia (IC/FUC)o Grande do Sul / Fundação Universitária de Cardiologia (IC/FUC)

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: August 17, 2025
• Study Start: July 29, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)