- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02951624
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors (BPS2)
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Copenhagen, Danmark, 2100
- Center for Physical Activity Research, Copenhagen University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
AUC post prandial glucose concentration
Tidsramme: 6 hours
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6 hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mathias Ried, PhD, Group Leader
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 53476
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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