Cardiovascular Risk in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time
2. september 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering (Forventet)
16
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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São Paulo
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Ribeirão Preto, São Paulo, Brasil, 14048-900
- Rekruttering
- Clinics Hospital of the Ribeirao Preto Medical School
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in blood glucose area under curve during 5 hours in four different phases of intervention
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of physical performance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
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4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Eduardo Ferriolli, PhD, USao Paulo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2015
Primær fullføring (Forventet)
1. desember 2016
Studiet fullført (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
26. juli 2016
Først innsendt som oppfylte QC-kriteriene
2. september 2016
Først lagt ut (Anslag)
9. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1563/2015
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .