- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02258438
Effect of Breaking up Prolonged Sitting on Metabolic Flexibility
29 aprile 2021 aggiornato da: University of Colorado, Denver
The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting.
The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Although public-health recommendations to engage in moderate-to-vigorous physical activity (at least 30min, 5 days / week) have been widely promulgated by the government, most people are physically inactive.
Sedentary behaviors, like time spent sitting, are associated with serious implications on metabolic health, indicating that even in individuals who regularly exercise a reduction in time spent sitting can confer health benefits.
Encouraging recent evidence shows that walking breaks throughout the day are an effective strategy to offset the deleterious effects of prolonged uninterrupted sitting.
Further data however are needed to better understand the effect of these microbursts of activity along the day.
The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting.
Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of substrate (glucose, fat or protein) to provide energy to the body in response to meals consumption will be measured on day 3 of each of these three conditions.
The investigators will furthermore assess the ability of the participants to perform the interventions on physical activity at the end of each day over the three days of intervention (2 days in free-living conditions and one day in a controlled environment).
The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.
This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches like structured exercise.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
28
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 19 anni a 45 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- overweight but weight stable (less than +/- 3kg over previous 6 months) male and female adults (n=24) will be recruited.
- age between 19-45 years old,
- a BMI of 27-33 kg/m2,
- inactive (≤ 1.5hr/wk of moderate-to-vigorous activity),
- sedentary (office employees who are spending more than 6hrs/day in sitting position) and
- English-speaking.
Exclusion Criteria:
- any history of renal, cardiovascular or hepatic diseases,
- type 1 or 2 diabetes,
- cancer,
- pregnancy,
- smoking,
- consumption of drugs or alcohol (>40g/d),
- any medications known to interfere with lipid or energy metabolism,
- known physical activity contraindications, or major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities and
- menopause (defined as no menses in the prior 6 months). The use of birth pill control will be accepted. Women are asked to avoid pregnancy until completion of Condition C.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Uninterrupted sitting
Patient will refrain from any structured activity and reduce any daily life activity.
The patient will spend 24 hours in the calorimeter room.
During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read.
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Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life.
On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.
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Sperimentale: Sitting + 1 bout of activity
The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life.
This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter.
During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill.
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Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life.
On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.
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Sperimentale: Sitting + microbursts of activity
The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800.
On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter.
During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min.
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Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life.
On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Total substrate oxidation
Lasso di tempo: 1 day
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Total fat oxidation during the test day will be determined using whole-room indirect calorimetry.
O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described
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1 day
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Postprandial plasma insulin and glucose response
Lasso di tempo: 1 day
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Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption.
The area under the curve will be calculated for both plasma glucose and insulin.
This area will represent the postprandial response to a meal for both insulin and glucose.
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1 day
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Dietary fat oxidation
Lasso di tempo: 1 day
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Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure.
Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS).
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1 day
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 ottobre 2014
Completamento primario (Effettivo)
1 settembre 2017
Completamento dello studio (Effettivo)
1 settembre 2017
Date di iscrizione allo studio
Primo inviato
2 ottobre 2014
Primo inviato che soddisfa i criteri di controllo qualità
6 ottobre 2014
Primo Inserito (Stima)
7 ottobre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 aprile 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 14-0429
- UL1TR001082 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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