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

NCT ID: NCT06262256

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-22

Brief Summary

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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

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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.

Conditions

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High-Intensity Interval Training Metabolic Syndrome Myocardial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial with control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Echocardiography evaluators will be masked about participant allocation.

Study Groups

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Control

Regular medical treatment for patients with metabolic syndrome.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type BEHAVIORAL

supervised exercise conducted on stationary bikes after individualized intensity prescription.

Interventions

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High-intensity interval training

supervised exercise conducted on stationary bikes after individualized intensity prescription.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complejo Hospitalario de Toledo

OTHER

Sponsor Role collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan F Ortega Fonseca, MD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Locations

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University of Castilla-La Mancha

Toledo, Castille-La Mancha, Spain

Site Status

Countries

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Spain

References

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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 JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

Reference Type RESULT
PMID: 34447992 (View on PubMed)

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: 10.1136/jech.2006.048173.

Reference Type RESULT
PMID: 17183018 (View on PubMed)

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;21(12):E679-86. doi: 10.1002/oby.20537. Epub 2013 Aug 23.

Reference Type RESULT
PMID: 23804526 (View on PubMed)

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 with metabolic syndrome. Nutr Metab Cardiovasc Dis. 2014 Jul;24(7):792-8. doi: 10.1016/j.numecd.2014.01.011. Epub 2014 Jan 29.

Reference Type RESULT
PMID: 24656853 (View on PubMed)

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 Syndr Obes. 2022 May 20;15:1553-1562. doi: 10.2147/DMSO.S352490. eCollection 2022.

Reference Type RESULT
PMID: 35619799 (View on PubMed)

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.

Reference Type RESULT
PMID: 35296909 (View on PubMed)

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 randomized trial. Metabolism. 2016 Sep;65(9):1350-60. doi: 10.1016/j.metabol.2016.05.006. Epub 2016 May 18.

Reference Type RESULT
PMID: 27506742 (View on PubMed)

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):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.

Reference Type RESULT
PMID: 19270053 (View on PubMed)

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, Zhang Y, Blitz A, Lang RM; WASE Investigators. Similarities and Differences in Left Ventricular Size and Function among Races and Nationalities: Results of the World Alliance Societies of Echocardiography Normal Values Study. J Am Soc Echocardiogr. 2019 Nov;32(11):1396-1406.e2. doi: 10.1016/j.echo.2019.08.012.

Reference Type RESULT
PMID: 31679581 (View on PubMed)

Other Identifiers

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HIIT-GLS-METS

Identifier Type: -

Identifier Source: org_study_id

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