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- Klinische proef NCT02738385
Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)
24 oktober 2016 bijgewerkt door: Robinson Ramírez-Vélez, Universidad Santo Tomas
High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health.
It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors.
For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bogotá, Colombia
- Robinson Ramírez Vélez Ph.D
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Written informed consent.
- Interested in improving health and fitness.
Exclusion Criteria:
- Systemic infections.
- Weight loss or gain of >10% of body weight in the past 6 months for any reason.
- Currently taking medication that suppresses or stimulates appetite.
- Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Asthma.
- Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
- Any active use of illegal or illicit drugs.
- Current exerciser (>30 min organized exercise per week).
- Indication of unsuitability of current health for exercise protocol (PARQ).
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: High Intensity Interval Training
Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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Actieve vergelijker: Moderate Intensity Interval Training
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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FMD will be measured using the guidelines reported by Corretti et al.
The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline in LDL Cholesterol
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in HDL Cholesterol
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Triglycerides
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Glucose
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Heart rate variability
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Aortic pulse wave velocity (PWVao)
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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PWVao (m s-1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in muscular fitness
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Flexibility using the sit and reach test
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in peak uptake of volume of oxygen
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Blood Pressure
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass Index
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Tijdsspanne: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Augmentation index (AIx)
Tijdsspanne: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
- Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
- Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6. Erratum In: J Transl Med. 2017 Jun 13;15(1):136.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2015
Primaire voltooiing (Werkelijk)
1 oktober 2016
Studie voltooiing (Werkelijk)
1 oktober 2016
Studieregistratiedata
Eerst ingediend
23 maart 2016
Eerst ingediend dat voldeed aan de QC-criteria
8 april 2016
Eerst geplaatst (Schatting)
14 april 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
25 oktober 2016
Laatste update ingediend die voldeed aan QC-criteria
24 oktober 2016
Laatst geverifieerd
1 oktober 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 01-1802-2013
Plan Individuele Deelnemersgegevens (IPD)
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