Clinical trial NCT02894099: Cardiovascular Risk in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time
Official title: Blood Glucose, Insulin Response and Inflammatory Markers in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Aged
Sedentary Behaviour
Blood Glucose
Insulin
Inflammatory markers
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood glucose area under curve during 5 hours in four different phases of intervention
timeFrame: 4 weeks
measure: Change in insulin area under curve during 5 hours in four different phases of intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of physical performance
timeFrame: 1 day
measure: Assessment of handgrip strength
timeFrame: 1 day
measure: Assessment of muscle strength of knee extensors
timeFrame: 1 day
measure: Physical Activity behaviour
timeFrame: 7 days
measure: Change in Inflammatory Cytokines area under curve during 5 hours in four different phases of intervention
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of the Ribeirao Preto Medical School
state: São Paulo
Study officials:
affiliation: USao Paulo
name: Eduardo Ferriolli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.