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

NCT02894099 | Unknown

• 1 other identifier: 1563/2015
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle

Keywords

Aged; Sedentary Behaviour; Blood Glucose; Insulin; Inflammatory markers

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Assessment of physical performance

  1 day

• Assessment of handgrip strength

  1 day

• Assessment of muscle strength of knee extensors

  1 day

• Physical Activity behaviour

  7 days

• Change in Inflammatory Cytokines area under curve during 5 hours in four different phases of intervention

  4 weeks

Study Arms (4)

Prolonged Sitting Time (PST)

EXPERIMENTAL

Uninterrupted sitting time of 5 hours

Other: Prolonged sitting time

PST+Light intensity Short bouts PA

EXPERIMENTAL

Sitting prolonged interrupted with breaks of 2 minutes of light physical activity

Other: PST+Light intensity Short bouts PA

PST+Moderate intensity Short bouts PA

EXPERIMENTAL

Sitting prolonged interrupted with breaks of 2 minutes of moderate physical activity

Other: PST+Moderate intensity Short bouts PA

PST+Moderate intensity Long bouts PA

EXPERIMENTAL

Sitting prolonged interrupted with breaks of 10 minutes of moderate physical activity

Other: PST+Moderate intensity Long bouts PA

Interventions

Prolonged sitting time OTHER

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.

Prolonged Sitting Time (PST)

PST+Light intensity Short bouts PA OTHER

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+Light intensity Short bouts PA

PST+Moderate intensity Short bouts PA OTHER

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 Short bouts PA

PST+Moderate intensity Long bouts PA OTHER

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.

PST+Moderate intensity Long bouts PA

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinics Hospital of the Ribeirao Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 22374636 BACKGROUND

• 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.

  PMID: 26378942 BACKGROUND

• 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.

  PMID: 24704421 BACKGROUND

• 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.

  PMID: 26308477 BACKGROUND

• 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.

  PMID: 26872294 BACKGROUND

• 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.

  PMID: 24209423 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Insulin Resistance

Condition Hierarchy (Ancestors)

Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eduardo Ferriolli, PhD

  USao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda PA Pessanha, Master

CONTACT

+5516981135032; fernandapessanha@usp.br

Priscila G Fassini, PhD

CONTACT

+551633153370; priscilafassini@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: September 9, 2016
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)