Breaking Prolonged Sitting With Physical Activity Clinical Trial
Great controversy exists with respect to the optimal or the minimum volume, intensity, and
frequency of physical activity capable of attenuating the hazards of prolonged sitting on
the metabolic profile. Thus, our study aims to comprehensively investigate the effects of
disrupting prolonged sitting with different physical activity protocols on metabolic risk
factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four
27-h conditions. All conditions will be identical except for the physical activity:
prolonged sitting intervention (SIT) participants will sit continuously for 9 hours;
prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min
every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged
sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min
moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they
will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout
+interval standing intervention (MVPA-STAND), participants will perform a 30-min
moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they
will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of
sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a
moderate-exercise bout will positively affect the metabolic profile of the participants.
Furthermore, we will investigate if combined, these strategies will have an additive effect.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 25 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Males, - age 25-55 y, - BMI >18 and <35 kg/m2 Exclusion Criteria: - Clinically diagnosed diabetes, - dyslipidaemia, - hypertension, - use of glucose- and/or lipid-lowering medication, - smoking, - evidence of thyroid, liver, lung, heart or kidney disease, - non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months, - VO2max levels above the considered average fitness according to age, - contraindication to increased levels of physical activity. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Centre of Inflammation and Metabolism | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Area under the curve of cytokine postprandial responses | Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC). | 27 h | No |
| Primary | Area under the curve of glucose and insulin postprandial responses | Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC). | 27 h | No |
| Secondary | Glucose levels | Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours. Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l). | 27 hours | No |
| Secondary | Area under the curve of lipid postprandial responses | Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC). | 27 h | No |