Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients

Not Applicable

Completed

• Conditions: Myocardial Dysfunction; High-Intensity Interval Training; Metabolic Syndrome
• Interventions: Behavioral: High-intensity interval training

• Registration Number: NCT06262256
• Lead Sponsor: University of Castilla-La Mancha

Brief Summary

the effects of high-intensity interval training on myocardial function will be studied in a group of patients under medical treatment for the components of metabolic syndrome.

Detailed Description

Objective: To analyze the effects of high-intensity interval training (HIIT) on myocardial function of metabolic syndrome patients.

Methods and design. Randomized clinical trial with a control group. Project was developed in association with the regional general hospital. Pre and post-intervention evaluation after 16 weeks of training for the HIIT group.

Subjects: Recruited using adverts published on public medical center boards. Up to 30 subjects per group (HIIT and CONTROL) will be recruited (at least 20% women) Measurements. Echocardiography: Global longitudinal strain (GLS), Mitral filling parameters, myocardial dimensions, and myocardial wall thickness.

Cardiorespiratory fitness: Maximal oxygen consumption, Maximal power output, Maximal oxygen pulse.

Clinical: Metabolic syndrome components and derived variables (e.g., triglycerides/high-density lipoprotein ratio) Body composition by anthropometric measurements and dual-energy X-ray absorptiometry.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-12-22
• Study First Submitted: 2024-01-19
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of metabolic syndrome.
• Capacity to exercise on a stationary bike
• Inhabitant of the province of Toledo

Exclusion Criteria

• Untreated cardiovascular disease with hemodynamic instability
• Untreated respiratory disease, symptomatic.
• Untreated metabolic disease.
• Untreated renal disease requiring dialysis.
• Contraindications for high-intensity exercise training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-intensity interval training	High-intensity interval training	Regular medical treatment for patients with metabolic syndrome plus, 16 weeks of high-intensity interval training (3-times/week, 50 min/session conducted on stationary bike).

Primary Outcome Measures

Name	Time	Method
Changes in global longitudinal strain	up to 16 weeks	response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage

Secondary Outcome Measures

Name	Time	Method
changes in cardiorespiratory fitness	up to 16 weeks	changes in maximal oxygen consumption measured in litres/min, all assessed by a cardiopulmonary exercise test in cycle-ergometer with breath by breath gas analysis.
changes in metabolic syndrome z-score	up to 16 weeks	Adimensional variable used to assess in a unified score, the changes in the components of metabolic syndrome. The z-score is based on the cut-off points ot the components(fasting serum concentrations of glucose, triglycerides, and high density lipoprotein, all measured in mg/DL), waist circumference measured in cm, systolic and diastolic blood pressure measured in mm Hg), and the variance of each variable among participants assessed by the standard deviation.
changes in estimated left ventricle filling pressures (E/e')	up to 16 weeks	changes in estimated left ventricle filling pressures by E/e' ratio (Peak E-wave velocity divided by the peak e' velocity) obtained by echocardiography, being E and e' measured in m/seg.
changes in visceral fat	up to 16 weeks	changes in visceral fat after intervention, assessed by dual-energy x-ray absortiometry. Measured in kg.
changes in left ventricle passive filling (E wave)	up to 16 weeks	changes in early diastolic mitral inflow velocity (E wave), assessed by echocardiography. Measured in m/seg.
changes in early diastolic mitral annulus velocity (e' wave)	up to 16 weeks	changes in early diastolic mitral annulus velocity (e' wave), assessed by echocardiography. Measured in m/seg.

Trial Locations

Locations (1)

University of Castilla-La Mancha; 🇪🇸 Toledo, Castilla-La Mancha, Spain