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Changes in vascular function after a reduced sitting intervention


- candidate number27080
- NTR NumberNTR6387
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDs2016-3036 NL60126.091.16
- Public TitleChanges in vascular function after a reduced sitting intervention
- Scientific TitleChanges in vascular function after a reduced sitting intervention
- ACRONYM
- hypothesisVascular function improves after a reduced sitting intervention
- Healt Condition(s) or Problem(s) studiedSedentary behavior, Cardiovascular disease risk
- Inclusion criteriaPeople who spend >40 hours per week sitting with an increased cardiovascular risk. An increased risk for cardiovascular disease was defined as those older than 45 years (men) or 55 (women) and presence of at least 1 cardiovascular risk factor.
- Exclusion criteriaPersons who are not physically able to perform light-intensity physical activity such as standing and walking.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 28-mrt-2017
- planned closingdate1-jul-2019
- Target number of participants30
- InterventionsReduced sitting intervention: throughout the day participants prevent prolonged (i.e. >30 min) seated behaviour. This will be accomplished by a pedometer, which records physical activity levels. This device has been used by several previous studies and is validated to measure sedentary behaviour and physical activity (35-37). After a period of prolonged sitting (i.e. 30-minutes), participants receive an alert (i.e. vibration of the wristband). Participants then break up their sitting time and replace it by a few minutes of low to moderate intensity exercise, such as standing and walking. We aim to reduce sitting with 90 minutes per day, and increase sit-to-stand transitions with 5 per day, as is in line with the improvement in comparable intervention studies (18, 38, 39).
- Primary outcomeThe main parameter of this study is the change in vascular function, as is measured by superficial femoral artery FMD at baseline, before and after intervention. Improvements in vascular function are associated with reduced risk for future cardiovascular events (17). Endothelial function will be measured before and after a challenge of 3 hours continuous sitting and after a challenge of 3 hours sitting with short bouts of light intensity activity every 30 minutes. This challenge will be repeated after the intervention period to evaluate whether the effects an acute challenge of prolonged sitting is different after intervention.
- Secondary outcomeCerebral autoregulation will serve as secondary outcome. Change in cerebral autoregulation and cerebrovascular reactivity will be measured after a challenge of 3 hours continuous sitting and after a challenge of 3 hours sitting with short bouts of light intensity activity every 30 minutes. As an explorative aim, markers of inflammation NO synthesis, coagulation and adhesion properties, and levels of oxidative stress will be secondary parameters in all subjects.
In addition, in all subjects physical fitness will be assessed as an explorative aim.
- TimepointsBaseline, 12 weeks control period, 12 weeks intervention
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Yvonne Hartman
- CONTACT for SCIENTIFIC QUERIES Yvonne Hartman
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications-
- Brief summaryRationale: Over the last years, physical inactivity has been identified as the major cause of death in Western society (2, 3). Despite recommendations for regular physical activity and promotion of exercise programmes, still a large proportion of the population does not meet these recommendations. Some years ago, epidemiologic studies have identified the association between sedentary behaviour (i.e. sitting and lying) and cardiovascular diseases or cardiovascular(CV) risk factors. Importantly, the detrimental impact of sitting time is not altered after correcting for exercise training time. Therefore, the benefits from “reduce sitting time” and exercise training seem independent from each other. Consequently, prolonged sitting is a logical target to improve cardiovascular risk factors via reduced sitting time. The first short term studies (i.e. hours and weeks) have revealed benefits in several CV risk factors. In this study, we will explore the longer term effects of a reduced sitting intervention on CV risk, and (cerebro)vascular factors.
Objective: In this intervention study we examine the effect of a 12-week reduced sitting time intervention on cardiovascular function (i.e. changes in femoral artery FMD) in subjects with an increased risk for cardiovascular disease. As a secondary objective, we want to obtain insights in the cerebrovascular effects of a reduced sitting intervention. Therefore, we will measure cerebrovascular function and peripheral vascular function. In addition, we will investigate the mechanism involved in mediating the impact of prolonged sitting on vascular function by exploring measures of inflammation, NO-pathway and metabolism.
Study design: stepped wedge design
Study population: We will recruit 30 individuals, who spend >40 hours per week sitting and <120 minutes of moderate-intensity exercise (or <75 minutes of vigorous-intensity exercise) per week. An increased risk for cardiovascular disease was defined as those older than 45 years (men) or 55 (women) and presence of at least 1 cardiovascular risk factor.
Intervention (if applicable): 12 weeks reduced sitting intervention: Subjects will wear a pedometer throughout the day in order to record physical activity patterns. The device identifies prolonged periods of sitting or physical inactivity, which will lead to notification that the participant has to break up his/her sitting behaviour to reduce sitting time.
Main study parameters/endpoints:
1) Peripheral vascular function
2) Cerebral autoregulation
- Main changes (audit trail)
- RECORD12-apr-2017 - 21-jun-2017


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