- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Rio de Janeiro, Brasilien, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: HIIT only
Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state
|
High-intensity interval exercise training in the fed state
|
Experimentell: CT+FAST
Volunteers will be submitted to continous training (CT) performed in the fasting state
|
Continous exercise training in the fasting state
|
Experimentell: CT only
Volunteers will be submitted to continous training (CT) performed in fed state.
|
Continous exercise training in the fed state
|
Experimentell: HIIT+FAST
Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.
|
High-intensity interval exercise training in the fasting state
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Capillary density
Tidsram: 6 months
|
Number of spontaneously perfused skin capillaries per mm2
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6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Microvascular reactivity assessed by laser speckle contrast imaging
Tidsram: 6 months
|
Skin microvascular flow in arbitrary perfusion units
|
6 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: EDUARDO V TIBIRICA, MD, PhD, National Innstitute of Cardiology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAAE:69240017.1.0000.5272
Läkemedels- och apparatinformation, studiedokument
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