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Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)

24. oktober 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Colombia
      • Bogotá, Colombia
        • Robinson Ramírez Vélez Ph.D

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: High Intensity Interval Training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Aktiv komparator: Moderate Intensity Interval Training
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
Adfærdsmæssigt: Moderate Intensity Interval Training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in LDL Cholesterol
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in HDL Cholesterol
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Triglycerides
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Glucose
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Heart rate variability
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Aortic pulse wave velocity (PWVao)
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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).
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in muscular fitness
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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®
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Flexibility using the sit and reach test
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in peak uptake of volume of oxygen
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Blood Pressure
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass Index
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Tidsramme: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Augmentation index (AIx)
Tidsramme: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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).
Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad Santo Tomas

Efterforskere

  • Studieleder: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

23. marts 2016

Først indsendt, der opfyldte QC-kriterier

8. april 2016

Først opslået (Skøn)

14. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01-1802-2013

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Metaboliske sygdomme

Kliniske forsøg med High Intensity Interval Training

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