- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02738385
Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)
24 oktober 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Bogotá, Colombia
- Robinson Ramírez Vélez Ph.D
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
|
Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from Baseline in LDL Cholesterol
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2015
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
23 mars 2016
Först inskickad som uppfyllde QC-kriterierna
8 april 2016
Första postat (Uppskatta)
14 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 01-1802-2013
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Metaboliska sjukdomar
-
Grand Valley State UniversityAnmälan via inbjudanMetabolic Associated-dysfunction Steatotic Lever Disease (MASLD) | Metabolic Associated-dysfunction Steatohepatit (MASH)Förenta staterna
-
Scripps Whittier Diabetes InstituteAvslutadCardio-metabolic Care-Team Intervention (CMC-TI)
-
Shanghai General Hospital, Shanghai Jiao Tong University...Har inte rekryterat ännuPrediabetes | Kontinuerlig glukosövervakning | Metabolic Management Center
Kliniska prövningar på High Intensity Interval Training
-
Lund UniversityThe Swedish Research Council; Region Skane; Halmstad UniversityRekryteringCerebral pares | Träning | BarnSverige
-
Duke UniversityVanderbilt UniversityAvslutadHögintensiv intervallträning | Kritisk sjukdom | Covid19 | Fitness Trackers | ICU | IntensivvårdsavdelningarFörenta staterna
-
Kennesaw State UniversityAvslutad
-
University of New BrunswickNew Brunswick Health Research FoundationAvslutad
-
Riphah International UniversityRekrytering
-
University of MinnesotaIndragenSchizofreni | Schizoaffektiv sjukdom | PsykosFörenta staterna
-
Seattle Children's HospitalLouisiana State University Health Sciences Center in New OrleansAvslutad
-
Hospices Civils de LyonAvslutadLokaliserad prostatacancerFrankrike
-
The Hospital for Sick ChildrenSunnybrook Health Sciences CentreAvslutadSmärta | Osteoid osteom | Benign bentumörKanada
-
Kristie BjornsonUniversity of Washington; Louisiana State University Health Sciences Center...Rekrytering