- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03236285
Microvascular and Metabolic Effects of High-intensity Interval Exercise Training (HIIT-FAST)
Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.
Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Rio de Janeiro, Brasil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Female gender
- Age≥ 30 years and ≤50 years
- Premenopausal status
- Body mass index >25 kg/m2
- At least one of the following:
waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol <50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl
Exclusion Criteria:
- Any cardiovascular disease, including systemic hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
- Orthopedic or neurologic conditions that might impair exercise training
- Pregnancy or breastfeeding
- Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
- Current engagement in any exercise training protocol
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: HIIT only
Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state
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High-intensity interval exercise training in the fed state
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Eksperimentell: CT+FAST
Volunteers will be submitted to continous training (CT) performed in the fasting state
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Continous exercise training in the fasting state
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Eksperimentell: CT only
Volunteers will be submitted to continous training (CT) performed in fed state.
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Continous exercise training in the fed state
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Eksperimentell: HIIT+FAST
Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.
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High-intensity interval exercise training in the fasting state
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Capillary density
Tidsramme: 6 months
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Number of spontaneously perfused skin capillaries per mm2
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Microvascular reactivity assessed by laser speckle contrast imaging
Tidsramme: 6 months
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Skin microvascular flow in arbitrary perfusion units
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6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: EDUARDO V TIBIRICA, MD, PhD, National Innstitute of Cardiology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAAE:69240017.1.0000.5272
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