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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06262256
• Other study ID #: HIIT-GLS-METS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: February 2024
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 22, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• High-Intensity Interval Training
• Metabolic Syndrome
• Myocardial Dysfunction
• Syndrome

Intervention

Behavioral:
• High-intensity interval training
supervised exercise conducted on stationary bikes after individualized intensity prescription.

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha	Toledo	Castilla-La Mancha

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Complejo Hospitalario de Toledo

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Asch FM, Miyoshi T, Addetia K, Citro R, Daimon M, Desale S, Fajardo PG, Kasliwal RR, Kirkpatrick JN, Monaghan MJ, Muraru D, Ogunyankin KO, Park SW, Ronderos RE, Sadeghpour A, Scalia GM, Takeuchi M, Tsang W, Tucay ES, Tude Rodrigues AC, Vivekanandan A, Zha — View Citation

Crendal E, Walther G, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Rupp T, Courteix D, Obert P. Myocardial deformation and twist mechanics in adults with metabolic syndrome: impact of cumulative metabolic burden. Obesity (Silver Spring). 2013 Dec — View Citation

Li C, Ford ES, McGuire LC, Mokdad AH. Association of metabolic syndrome and insulin resistance with congestive heart failure: findings from the Third National Health and Nutrition Examination Survey. J Epidemiol Community Health. 2007 Jan;61(1):67-73. doi — View Citation

McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray — View Citation

Mora-Rodriguez R, Ortega JF, Hamouti N, Fernandez-Elias VE, Canete Garcia-Prieto J, Guadalupe-Grau A, Saborido A, Martin-Garcia M, Guio de Prada V, Ara I, Martinez-Vizcaino V. Time-course effects of aerobic interval training and detraining in patients wit — View Citation

Murray J, Bennett H, Bezak E, Perry R, Boyle T. The effect of exercise on left ventricular global longitudinal strain. Eur J Appl Physiol. 2022 Jun;122(6):1397-1408. doi: 10.1007/s00421-022-04931-5. Epub 2022 Mar 16. — View Citation

Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):1 — View Citation

Serrano-Ferrer J, Crendal E, Walther G, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Courteix D, Obert P. Effects of lifestyle intervention on left ventricular regional myocardial function in metabolic syndrome patients from the RESOLVE randomize — View Citation

Smith BE, Peterman JE, Harber MP, Imboden MT, Fleenor BS, Kaminsky LA, Whaley MH. Change in Metabolic Syndrome and Cardiorespiratory Fitness Following Exercise Training - The Ball State Adult Fitness Longitudinal Lifestyle Study (BALL ST). Diabetes Metab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in global longitudinal strain	response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage	up to 16 weeks
Secondary	changes in cardiorespiratory fitness	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
Secondary	changes in metabolic syndrome z-score	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
Secondary	changes in visceral fat	changes in visceral fat after intervention, assessed by dual-energy x-ray absortiometry. Measured in kg.	up to 16 weeks
Secondary	changes in left ventricle passive filling (E wave)	changes in early diastolic mitral inflow velocity (E wave), assessed by echocardiography. Measured in m/seg.	up to 16 weeks
Secondary	changes in early diastolic mitral annulus velocity (e' wave)	changes in early diastolic mitral annulus velocity (e' wave), assessed by echocardiography. Measured in m/seg.	up to 16 weeks
Secondary	changes in estimated left ventricle filling pressures (E/e')	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