Hasselt University
Diepenbeek, Limburg, 3590, Belgium
NCT Number: NCT07419100
According to the World Health Organization (WHO), chronic diseases are a major global public health concern and the leading cause of mortality worldwide. In the absence of evidence-based actions, the global annual deaths from chronic diseases are projected to rise to 55 million deaths in 2030, accompanied by a substantial increase in socio-economic costs. In this context, the WHO identifies type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) as key chronic conditions of concern related to cardiometabolic health.
Both sedentary behaviour (SB) and physical inactivity have been recognised as interdependent risk factors for the development of T2DM and CVD. SB refers to any waking behaviour, characterised by a low energy expenditure, while being in a sitting or reclining posture, whereas physical inactivity denotes insufficient levels (<150 min per week,) of moderate-to-vigorous physical activity (MVPA). Studies using objective measures have demonstrated that on average Western adults spend 8-12h in SB per day, of which the majority is spent in prolonged sedentary bouts (lasting ≥30 min). In addition, up to 30% of adults worldwide are physically inactive, with higher levels of inactivity in high-income countries. Within this context, it has become evident that excessive prolonged SB, often in combination with physical inactivity, negatively impacts cardiometabolic health, contributing to insulin resistance, increased adiposity, poor lipid profiles and endothelial dysfunction. Given their detrimental effects on T2DM and CVD, strategies aimed at reducing SB and promoting physical activity (PA) warrant further investigation.
Reducing and regularly interrupting SB, even with low-intensity PA, alongside sufficient MVPA, is crucial for maintaining a healthy cardiometabolic profile. Reflecting this, the WHO guidelines advise individuals to engage in 150-300 minutes of moderate-intensity physical activity, 75-150 minutes of vigorous-intensity physical activity, or an equivalent combination each week. Notably, the 2020 WHO guidelines also included recommendations on SB for the first time, emphasizing the importance of limiting sedentary time. The WHO states that replacing SB with physical activity of any intensity can yield health benefits. However, these recommendations remain non-prescriptive and somewhat vague, primarily due to a lack of robust scientific evidence on the optimal frequency, intensity, and duration of PA needed to interrupt sedentary time. The absence of specific guidelines on prolonged SB reflects this evidence gap. To support policy development, well-designed randomised controlled trials are needed to evaluate effective and practical strategies for reducing sedentary time.
So far, the short term cardiometabolic health effects of SB interruptions have been investigated by our research group, laboratory studies of collaborators and other international researchers, demonstrating that; 1) more frequent SB interruptions especially affect glucose metabolism and insulin sensitivity; 2) higher intensity interruptions are associated with cardioprotective adaptations and; 3) longer durations of SB interruptions positively affect lipid metabolism. However, because under real-world conditions frequency, intensity and duration of SB interruptions usually interact, their combined effects on cardiometabolic health need further investigation. Many studies already compared the isolated effects of different SB interruption patterns with respect to frequency, duration and intensity on cardiometabolic health. However, the combined effects of these different approaches matched for energy expenditure are not clear yet. We therefore perform a balanced cross-over study in which the efficacy of distinct activity patterns on cardiometabolic health insulin sensitivity and vascular function) will be compared to a sedentary control condition.
Trial opening soon.
Get Notified40 year–70 year
All sexes
Interventional
Not applicable
Diepenbeek, Limburg, 3590, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One continuous physical activity bout of moderate intensity will be performed during the 6 hour testing day.
Light-intensity physical activity breaks every 30 minutes during the 6 hour testing day.
High-intensity physical activity breaks every 30 minutes during the 6 hour testing day.
Time frame: Blood samples will be collected at 0, 30, 60, 120, 180, 210, 240, 300, and 360 minutes during the 6-hour testing day.
Insulin concentrations will be assessed in serum samples at nine time points over the 6-hour testing period. Postprandial responses will be quantified as the area under the curve (AUC) across the six-hour period.
Time frame: FMD measurement will be performed at the start (08:30 a.m.) and after 6 hours (2:30 p.m.) of the testing day.
Vascular endothelial function will be assessed by flow-mediated dilation (FMD) according to published guidelines. These measurements take place at 8 a.m. and involve doppler ultrasound imaging of the superficial femoral artery. A cuff will be placed on the right lower leg, and the superficial femoral artery is imaged longitudinally. FMD will be measured at baseline and after a 5-min occlusion phase (reactive hyperaemia response). FMD will be quantified as the percentage difference between peak and baseline diameter (FMD%).
Time frame: Baseline measurement
Cardiorespiratory fitness will be measured as peak oxygen consumption (V̇O2peak) using a graded cardiopulmonary exercise test (CPET) on a bike with pulmonary gas exchange analysis (Metalyzer IIIb) until volitional exhaustion.
Time frame: Measured for 7 consecutive days after the screening visit
Sedentary time will be quantified using the activPAL3™ activity monitor.
Time frame: Baseline measurement
Body mass index (BMI; kg/m²) is calculated from weight and height measurements (weight/height²).
Time frame: Measured for 7 consecutive days after the screening visit
Moderate-to-vigorous physical activity will be quantified using the activPAL3™ activity monitor.
Time frame: Baseline measurement
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg.
Time frame: Blood samples will be taken at the beginning of the testing day (8 a.m.).
High-density lipoprotein cholesterol concentration will be measured in fasting plasma samples
Time frame: Blood samples will be taken at the beginning of the testing day (8 a.m.).
Total cholesterol concentration will be measured in fasting plasma samples
Time frame: Blood samples will be collected at 0, 30, 60, 120, 180, 210, 240, 300, and 360 minutes during the 6-hour testing day.
Glucose concentrations will be assessed in plasma samples at nine time points over the 6-hour testing period. Postprandial responses will be quantified as the area under the curve (AUC) across the six-hour period.
Time frame: Blood samples will be collected at 0, 30, 60, 120, 180, 210, 240, 300, and 360 minutes during the 6-hour testing day.
Triglyceride concentrations will be assessed in plasma samples at nine time points over the 6-hour testing period. Postprandial responses will be quantified as the area under the curve (AUC) across the six-hour period.
Time frame: Baseline measurement
Peak heart rate assessed during cardiopulmonary exercise testing
Time frame: Blood pressure will be measured during the screening visit, and hourly at 0, 60, 120, 180, 240, 300, and 360 minutes during the 6-hour testing day.
After an initial resting period of 10 min with participants in a supine position in a quiet room with constant temperature (21°C), systolic and diastolic blood pressure (BP; in mmHg) will be measured at least 3 times at 2-min intervals until BP is stable using an electronic sphygmomanometer (Omron®) from the left arm and documented as the mean value of the three final measurements.
Time frame: Baseline measurement
Percentage body fat will be evaluated using Dual Energy X-ray Absorptiometry.
Time frame: Blood samples will be taken at the beginning of the testing day (8 a.m.).
Low-density lipoprotein cholesterol concentration will be measured in fasting plasma samples
Time frame: Baseline measurement
Contact information is provided by the study sponsor or research team.
Bert Op 't Eijnde, PhD
CONTACT
Wouter Franssen, PhD
CONTACT
Hasselt University
Other
From Sitting to Moving: How Physical Activity Patterns Can Reduce Sedentary Behaviour and Support Cardiometabolic Health
Acronym: SPARC
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