High-Intensity Interval TrainingNCT06262256
Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients
A study testing High-intensity interval training in people with High-Intensity Interval Training and Metabolic Syndrome, run by University of Castilla-La Mancha at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- High-Intensity Interval Training, Metabolic Syndrome, Myocardial Dysfunction
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of metabolic syndrome.
- Capacity to exercise on a stationary bike
- Inhabitant of the province of Toledo
Who cannot join
- Untreated cardiovascular disease with hemodynamic instability
- Untreated respiratory disease, symptomatic.
- Untreated metabolic disease.
- Untreated renal disease requiring dialysis.
- Contraindications for high-intensity exercise training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- High-intensity interval training
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
supervised exercise conducted on stationary bikes after individualized intensity prescription.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in global longitudinal strain
response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage
Measured: up to 16 weeks
Secondary outcomes (6)
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.
Measured: up to 16 weeks
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.
Measured: up to 16 weeks
changes in visceral fat
changes in visceral fat after intervention, assessed by dual-energy x-ray absortiometry. Measured in kg.
Measured: up to 16 weeks
changes in left ventricle passive filling (E wave)
changes in early diastolic mitral inflow velocity (E wave), assessed by echocardiography. Measured in m/seg.
Measured: up to 16 weeks
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.
Measured: up to 16 weeks
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.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2022
- Primary completion30 May 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for High-Intensity Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Toledo
- Responsible party
- Sponsor
- Investigators
- Juan F Ortega Fonseca, MD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262256
- Sponsor's protocol ID
- HIIT-GLS-METS
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34447992Li 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.
PubMed 17183018Crendal 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.
PubMed 23804526Mora-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.
PubMed 24656853Smith 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.
PubMed 35619799Murray 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.
PubMed 35296909Serrano-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.
PubMed 27506742Nagueh 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.
PubMed 19270053Asch 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.
PubMed 31679581Ortega JF, Garcia-Camacho E, Gadella-Fernandez A, Morales-Palomo FA, Moreno-Cabanas A, Alvarez-Jimenez L, Mora-Rodriguez R, Gallango-Brejano M. Effects of repeated periods of high-intensity interval training on myocardial function in patients with metabolic syndrome: A 16-month follow-up. J Cardiol. 2026 May 4:S0914-5087(26)00087-0. doi: 10.1016/j.jjcc.2026.04.007. Online ahead of print.
PubMed 42086168
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training on Myocardial Strain in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06262256
- Acronym / sponsor ID
- HIIT-GLS-METS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Toledo
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with control group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Regular medical treatment for patients with metabolic syndrome. |
| High-intensity interval training | Experimental | Behavioral: High-intensity interval trainingRegular 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of metabolic syndrome.
- Capacity to exercise on a stationary bike
- Inhabitant of the province of Toledo
Key exclusion criteria (5 listed)
- Untreated cardiovascular disease with hemodynamic instability
- Untreated respiratory disease, symptomatic.
- Untreated metabolic disease.
- Untreated renal disease requiring dialysis.
- Contraindications for high-intensity exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingsupervised exercise conducted on stationary bikes after individualized intensity prescription. | Behavioural | High-intensity interval training |
Primary outcome
Changes in global longitudinal strain
Time frame: up to 16 weeks
response to myocardial strain after intervention. Assessed by echocardiography, measured as a percentage
6 secondary outcomes
changes in cardiorespiratory fitness
Time frame: up to 16 weeks
changes in metabolic syndrome z-score
Time frame: up to 16 weeks
changes in visceral fat
Time frame: up to 16 weeks
changes in left ventricle passive filling (E wave)
Time frame: up to 16 weeks
changes in early diastolic mitral annulus velocity (e' wave)
Time frame: up to 16 weeks
changes in estimated left ventricle filling pressures (E/e')
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Results publication: PubMed 34447992McDonagh 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.
- Results publication: PubMed 17183018Li 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.
- Results publication: PubMed 23804526Crendal 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.
- Results publication: PubMed 24656853Mora-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.
- Results publication: PubMed 35619799Smith 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.
- Results publication: PubMed 35296909Murray 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.
- Results publication: PubMed 27506742Serrano-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.
- Results publication: PubMed 19270053Nagueh 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.
- Results publication: PubMed 31679581Asch 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.
- Derived from this study: PubMed 42086168Ortega JF, Garcia-Camacho E, Gadella-Fernandez A, Morales-Palomo FA, Moreno-Cabanas A, Alvarez-Jimenez L, Mora-Rodriguez R, Gallango-Brejano M. Effects of repeated periods of high-intensity interval training on myocardial function in patients with metabolic syndrome: A 16-month follow-up. J Cardiol. 2026 May 4:S0914-5087(26)00087-0. doi: 10.1016/j.jjcc.2026.04.007. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Ortega Fonseca, MD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with High-Intensity Interval Training and Metabolic Syndrome, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in global longitudinal strain (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06262256, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.