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Completed

NCT Number: NCT06262256

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

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.

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Key information

Conditions

High-Intensity Interval Training Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Myocardial Dysfunction Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Castilla-La Mancha

Toledo, Castille-La Mancha, 45071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

Behavioral

supervised exercise conducted on stationary bikes after individualized intensity prescription.

Primary outcomes

  1. Changes in global longitudinal strain

    Time frame: up to 16 weeks

    response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage

Secondary outcomes

  1. changes in cardiorespiratory fitness

    Time frame: 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.

  2. changes in metabolic syndrome z-score

    Time frame: 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.

  3. changes in visceral fat

    Time frame: up to 16 weeks

    changes in visceral fat after intervention, assessed by dual-energy x-ray absortiometry. Measured in kg.

  4. changes in left ventricle passive filling (E wave)

    Time frame: up to 16 weeks

    changes in early diastolic mitral inflow velocity (E wave), assessed by echocardiography. Measured in m/seg.

  5. changes in early diastolic mitral annulus velocity (e' wave)

    Time frame: up to 16 weeks

    changes in early diastolic mitral annulus velocity (e' wave), assessed by echocardiography. Measured in m/seg.

  6. changes in estimated left ventricle filling pressures (E/e')

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Complejo Hospitalario de Toledo

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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