Cardiovascular Risk in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time

Sedentary Lifestyle Clinical Trial

Official title:

Blood Glucose, Insulin Response and Inflammatory Markers in Sedentary Elderly During Prolonged Sitting Time Versus Intermittent Sitting Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894099
• Other study ID #: 1563/2015
• Status: Recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: September 2, 2016
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: University of Sao Paulo
• Contact: Fernanda PA Pessanha, Master
• Phone: +5516981135032
• Email: fernandapessanha[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

Other:
• Prolonged sitting time
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.
• PST+Light intensity Short bouts PA
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.
• PST+Moderate intensity Short bouts PA
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.
• PST+Moderate intensity Long bouts PA
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.

Locations

Country	Name	City	State
Brazil	Clinics Hospital of the Ribeirao Preto Medical School	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose area under curve during 5 hours in four different phases of intervention	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.	4 weeks	No
Primary	Change in insulin area under curve during 5 hours in four different phases of intervention	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.	4 weeks	No
Secondary	Assessment of physical performance	The physical performance will be evaluated by the Short Physical Performance Battery test.	1 day	No
Secondary	Assessment of handgrip strength	Measure of handgrip strength with a manual dynamometer (Saehan)	1 day	No
Secondary	Assessment of muscle strength of knee extensors	Measure of muscle strength of the lower limbs (knee extension) with a isokinetic dynamometer (Biodex 4 Pro)	1 day	No
Secondary	Physical Activity behaviour	use of a tri-axial accelerometer to measure profile of spontaneous physical activity	7 days	No
Secondary	Change in Inflammatory Cytokines area under curve during 5 hours in four different phases of intervention	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	No