- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02894099
Cardiovascular Risk in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time
2 septembre 2016 mis à jour par: Eduardo Ferriolli, University of Sao Paulo
Blood Glucose, Insulin Response and Inflammatory Markers in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time
In adults, the sedentary behavior was related to cardiovascular risk markers, regardless of the level of physical activity (PA).
However, the interruption of prolonged sedentary time has shown positive results even when performed in breaks of low intensity and short duration of activity.
The aim of this study is to analyze the influence of a sedentary uninterrupted period, as well as different forms of breaks in sedentary time for the glycemic, insulin and inflammatory markers responses in older adults.
This is a controlled clinical trial to be conducted in older (≥ 65 years) and sedentary (<150 min / week of moderate to vigorous physical activity) people.
Those with BMI ≥ to 35.00 kg /m2; diabetic, on medication for glycemic control, or with absolute or relative contraindications to PA practice will not be included .
Participants will undergo four phases of intervention separated by an interval of 7 days: (1) Prolonged Sitting Time(PST), in which older people will stay for 5 hours seated; (2) Prolonged sitting with PA of light intensity and short duration (LiSd), time sitting is interrupted for PA bouts of 50-60% of the Heart Rate (HR)max; (3) Prolonged sitting with PA of moderate intensity and short duration (MiSd), time sitting will be interrupted for PA bouts of 65-75% predicted HR max; (4) Prolonged sitting with PA of moderate intensity and long duration (MiLd,) time sitting will be interrupted with PA bouts of 65-75% of HRmax.
PA bouts will be performed by walking into a hallway every 20 minutes of sitting time and will last 2 minutes, except in MiLd phase (10 minute breaks every 75 minutes).
To evaluate the effects of different PA interruptions in plasma glucose, serum insulin and inflammatory markers, blood samples will be collected serially (-30min, Baseline and 30min, 1h, 2h, 3h, 4h and 5h after a standardized meal.
It is expect that interruption of sedentary time, even with breaks of short duration and light intensity can bring benefits to cardiovascular risk markers even in the elderly.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Type d'étude
Interventionnel
Inscription (Anticipé)
16
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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São Paulo
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Ribeirão Preto, São Paulo, Brésil, 14048-900
- Recrutement
- Clinics Hospital of the Ribeirao Preto Medical School
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Sedentary older women according World Health Organization, defined as not performing moderate to vigorous physical activity and vigorous for 150 min / week for at least 3 months;
- BMI <to 35.00 kg / m2;
- Sign the Informed Consent.
Exclusion Criteria:
- Previous diagnosis of Diabetes Mellitus;
- Use of any medication for glycemic control;
- Orthopedic problems that impair walking or use of orthoses for walking.
- Relative or absolute contraindications to perform physical activity.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Prolonged Sitting Time (PST)
Uninterrupted sitting time of 5 hours
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Volunteers will be continuously sitting on a chair for 5 hours and should move the least possible.
If the participant needs to stand from the chair, the stage will be invalidated.
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Expérimental: PST+Light intensity Short bouts PA
Sitting prolonged interrupted with breaks of 2 minutes of light physical activity
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Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of low intensity.
In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 50-60% HR max predicted for the age and measured by heart rate monitor.
The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants.
In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes) of light intensity physical activity.
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Expérimental: PST+Moderate intensity Short bouts PA
Sitting prolonged interrupted with breaks of 2 minutes of moderate physical activity
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Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of moderate intensity.
In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor.
The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants.
In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes)of moderate intensity physical activity.
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Expérimental: PST+Moderate intensity Long bouts PA
Sitting prolonged interrupted with breaks of 10 minutes of moderate physical activity
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Volunteers will have their time sitting interrupted every 75 minutes for 10 minutes of physical activity of moderate intensity.
In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor.
The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants.
In the end the volunteers will be sitting 5 hours and have 30 minutes (3 bouts of 10 minutes) of moderate intensity physical activity.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in blood glucose area under curve during 5 hours in four different phases of intervention
Délai: 4 weeks
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Assessed by serial blood sampling.The first blood sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein.
The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal).
The results will be expressed in mg.dl.
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4 weeks
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Change in insulin area under curve during 5 hours in four different phases of intervention
Délai: 4 weeks
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Assessed by serial blood sampling.
The first blood sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein.
The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal).The results will be expressed in µIU/ml.
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4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of physical performance
Délai: 1 day
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The physical performance will be evaluated by the Short Physical Performance Battery test.
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1 day
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Assessment of handgrip strength
Délai: 1 day
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Measure of handgrip strength with a manual dynamometer (Saehan)
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1 day
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Assessment of muscle strength of knee extensors
Délai: 1 day
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Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)
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1 day
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Physical Activity behaviour
Délai: 7 days
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use of a tri-axial accelerometer to measure profile of spontaneous physical activity
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7 days
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Change in Inflammatory Cytokines area under curve during 5 hours in four different phases of intervention
Délai: 4 weeks
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Assessed by serial blood sampling.
The first sampling is performed 30 minutes before ingestion of a standard meal mixed solution composed of carbohydrate, fat and protein.
The collection of serial blood will be collected in time (-30min, Baseline, 30min, 1h, 2h, 3h, 4h and 5h after the meal).
|
4 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Eduardo Ferriolli, PhD, USao Paulo
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.
- Chastin SF, Egerton T, Leask C, Stamatakis E. Meta-analysis of the relationship between breaks in sedentary behavior and cardiometabolic health. Obesity (Silver Spring). 2015 Sep;23(9):1800-10. doi: 10.1002/oby.21180.
- Benatti FB, Ried-Larsen M. The Effects of Breaking up Prolonged Sitting Time: A Review of Experimental Studies. Med Sci Sports Exerc. 2015 Oct;47(10):2053-61. doi: 10.1249/MSS.0000000000000654.
- Bailey DP, Locke CD. Breaking up prolonged sitting with light-intensity walking improves postprandial glycemia, but breaking up sitting with standing does not. J Sci Med Sport. 2015 May;18(3):294-8. doi: 10.1016/j.jsams.2014.03.008. Epub 2014 Mar 20.
- Bailey DP, Broom DR, Chrismas BC, Taylor L, Flynn E, Hough J. Breaking up prolonged sitting time with walking does not affect appetite or gut hormone concentrations but does induce an energy deficit and suppresses postprandial glycaemia in sedentary adults. Appl Physiol Nutr Metab. 2016 Mar;41(3):324-31. doi: 10.1139/apnm-2015-0462. Epub 2015 Dec 14.
- Dunstan DW, Wiesner G, Eakin EG, Neuhaus M, Owen N, LaMontagne AD, Moodie M, Winkler EA, Fjeldsoe BS, Lawler S, Healy GN. Reducing office workers' sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial. BMC Public Health. 2013 Nov 9;13:1057. doi: 10.1186/1471-2458-13-1057.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2015
Achèvement primaire (Anticipé)
1 décembre 2016
Achèvement de l'étude (Anticipé)
1 décembre 2016
Dates d'inscription aux études
Première soumission
26 juillet 2016
Première soumission répondant aux critères de contrôle qualité
2 septembre 2016
Première publication (Estimation)
9 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 septembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2016
Dernière vérification
1 août 2016
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1563/2015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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