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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06262256
Enrollment
80
Registered
2024-02-15
Start date
2022-09-01
Completion date
2023-12-22
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Intensity Interval Training, Metabolic Syndrome, Myocardial Dysfunction

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.

Interventions

BEHAVIORALHigh-intensity interval training

supervised exercise conducted on stationary bikes after individualized intensity prescription.

Sponsors

Complejo Hospitalario de Toledo
CollaboratorOTHER
University of Castilla-La Mancha
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Echocardiography evaluators will be masked about participant allocation.

Intervention model description

Randomized clinical trial with control group

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in global longitudinal strainup to 16 weeksresponse to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage

Secondary

MeasureTime frameDescription
changes in metabolic syndrome z-scoreup to 16 weeksAdimensional 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 visceral fatup to 16 weekschanges in visceral fat after intervention, assessed by dual-energy x-ray absortiometry. Measured in kg.
changes in cardiorespiratory fitnessup to 16 weekschanges 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 early diastolic mitral annulus velocity (e' wave)up to 16 weekschanges in early diastolic mitral annulus velocity (e' wave), assessed by echocardiography. Measured in m/seg.
changes in estimated left ventricle filling pressures (E/e')up to 16 weekschanges 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 left ventricle passive filling (E wave)up to 16 weekschanges in early diastolic mitral inflow velocity (E wave), assessed by echocardiography. Measured in m/seg.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026