- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02951624
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors (BPS2)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Fifteen (n=15) sedentary adult overweight males will be included in the study. All participants will undergo the four interventions in a randomized cross-over design. Wash out between intervention will be minimum four days.
Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.), with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand or walk to go to the toilet.
Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low intensity walking.
Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low intensity walking
Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low intensity walking
All interventions will be matched for total physical activity as well as sitting. Thus, we aim for the active interventions to be iso-caloric.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Copenhagen, Danmark, 2100
- Center for Physical Activity Research, Copenhagen University Hospital
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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:
- Males, age 20-50 years, waist-to-height ratio ≥ 0.5 and/or waist circumference ≥ 102 cm.
Exclusion Criteria:
- Clinically diagnosed diabetes, uncontrolled hypertension, use of glucose- and/or lipid-lowering medication, smoking, evidence of thyroid, liver, lung, heart or kidney disease, non-sedentary occupation, and VO2max levels above the considered average fitness according to age (Shvartz & Reibold 1990), contraindications to increased levels of physical activity.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Control
Participants will spend 8 hours sedentary.
Sedentary time will be spent sitting in a chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.) Participants will only be allowed to stand or walk to go to the toilet.
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Control intervention
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Eksperimentell: Breaker
Participants will spend a total of 7 hours and 12 min sedentary and a total of 48 min breaking sitting time with LPA.
Sedentary time will be done in bouts of 18 min with 2 min of light walking.
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Short breaks of physical activity
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Eksperimentell: Intermediate
Total duration of sedentary time and LPA time will be the same as in Breaker.
Sedentary time will be done in bouts of 54 min with 6 min of LPA between each bout.
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Intermediate breaks of physical activity
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Eksperimentell: Prolonger
Total duration of sedentary time and LPA time will be the same as in Breaker.
Sedentary time will be done in bouts of 108 min with 12 min of LPA between each bout.
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longer breaks of physical activity
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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AUC post prandial glucose concentration
Tidsramme: 6 hours
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6 hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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AUC post prandial insulin concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial c-peptide concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial triglyceride concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial total cholesterol concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial ldl concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial hdl concentration
Tidsramme: 6 hours
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6 hours
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AUC post prandial glucagon concentration
Tidsramme: 6 hours
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6 hours
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Mean 24 hour glucose concentration
Tidsramme: 24 hours
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24 hours
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Variation in 24 hour glucose concentration
Tidsramme: 24 hours
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24 hours
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Maximum in 24 hour glucose concentration
Tidsramme: 24 hours
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24 hours
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mathias Ried, PhD, Group Leader
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
- 53476
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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