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

February 13, 2024 updated by: University of Castilla-La Mancha

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla-La Mancha
      • Toledo, Castilla-La Mancha, Spain, 45071
        • University of Castilla-La Mancha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Regular medical treatment for patients with metabolic syndrome.
Experimental: 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).
Behavioral: High-intensity interval training
supervised exercise conducted on stationary bikes after individualized intensity prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in global longitudinal strain
Time Frame: up to 16 weeks
response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage
up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 16 weeks
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.
up to 16 weeks
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.
up to 16 weeks
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.
up to 16 weeks
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.
up to 16 weeks
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.
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Complejo Hospitalario de Toledo

Investigators

  • Principal Investigator: Juan F Ortega Fonseca, MD, University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIIT-GLS-METS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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