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

NCT06262256 | Completed DMC

• 1 other identifier: HIIT-GLS-METS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Intensity Interval Training; Metabolic Syndrome; Myocardial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Changes in global longitudinal strain

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

  up to 16 weeks

Secondary Outcomes (6)

• changes in cardiorespiratory fitness

  up to 16 weeks

• changes in metabolic syndrome z-score

  up to 16 weeks

• changes in visceral fat

  up to 16 weeks

• changes in left ventricle passive filling (E wave)

  up to 16 weeks

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

  up to 16 weeks

Study Arms (2)

Control

NO INTERVENTION

Regular medical treatment for patients with metabolic syndrome.

High-intensity interval training

EXPERIMENTAL

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

Interventions

High-intensity interval training BEHAVIORAL

supervised exercise conducted on stationary bikes after individualized intensity prescription.

High-intensity interval training

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of metabolic syndrome.
• Capacity to exercise on a stationary bike
• Inhabitant of the province of Toledo

You may not qualify if:

• Untreated cardiovascular disease with hemodynamic instability
• Untreated respiratory disease, symptomatic.
• Untreated metabolic disease.
• Untreated renal disease requiring dialysis.
• Contraindications for high-intensity exercise training

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Complejo Hospitalario de Toledo: collaborator

Study Sites (1)

University of Castilla-La Mancha

Toledo, Castille-La Mancha, 45071, Spain

Location

Related Publications (9)

• 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.

  PMID: 34447992 RESULT

• 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.

  PMID: 17183018 RESULT

• 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.

  PMID: 23804526 RESULT

• 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.

  PMID: 24656853 RESULT

• 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.

  PMID: 35619799 RESULT

• 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.

  PMID: 35296909 RESULT

• 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.

  PMID: 27506742 RESULT

• 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.

  PMID: 19270053 RESULT

• 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.

  PMID: 31679581 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juan F Ortega Fonseca, MD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Echocardiography evaluators will be masked about participant allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial with control group

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 15, 2024
• Study Start: September 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 22, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)