- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337385
Interrupting Sitting With High Intensity Exercise on Vascular Function in Adolescents Before and After a Mixed Meal
The Effect of Prolonged vs. Interrupted Sitting With High Intensity Interval Exercise on Lower Limb Vascular Function in Adolescents Before and After a Mixed Meal
Study Overview
Status
Detailed Description
Participants will be required to visit the laboratory on three separate occasions. The first of which will be a preliminary visit to collect anthropometric data (e.g. stature and body weight) and participants will complete a combined ramp-incremental and supra-maximal test to exhaustion on a cycle ergometer to determine the work rate for the exercise in the subsequent experimental visits.
For the two experimental visits, participants will arrive to the laboratory after an overnight fast and an activPAL accelerometer will be attached to the midline of the participants' thigh for the duration of the visit to quantity sitting time.
Lower limb macro and micro-vascular function will be assessed using a single protocol through flow mediated dilation of the popliteal artery and post-occlusive reactive hyperaemia in the capillaries of the calf. Participants will then either sit for three hours or have this three hour sitting period interrupted with high intensity interval cycling exercise at 30, 90 and 150 minutes. Vascular function will then be reassessed before participants will be given a mixed meal challenge (58.4 g fat and 53.4 g sugar) with a three hour postprandial period where the participants will remain seated for the duration. At the end of the postprandial period, vascular function will be reassessed.
Blood pressure, heart rate and calf circumference will be assessed hourly throughout the experimental day. In addition, capillary blood samples will be collected at baseline, pre meal and each hour during the postprandial period and assessed for changes in plasma glucose, triglyceride, cholesterol and insulin concentrations.
Participants will be transported to the toilet by wheelchair to limit the amount of walking undertaken during the sitting period and this activity will be quantified by the activPAL accelerometers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Devon
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Exeter, Devon, United Kingdom, EX1 2LU
- University of Exeter
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female adolescents
- 12-15 years
Exclusion Criteria:
- Medications known to affect blood pressure, carbohydrate or fat metabolism
- Allergies to the test meal e.g. dairy or gluten
- Contraindications to exercise
- Individuals with special educational needs that mean they are unable to fully comprehend the demands of the study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3 hours of Prolonged Sitting
Participants will sit continuously for three hours before receiving a mixed meal challenge.
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Participants will be asked to remain seated for 3 hours and refrain from moving their lower limbs
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Experimental: 3 hours of interrupted sitting with hourly HIIE
Participants will have their three hour sitting period interrupted with high intensity interval cycling exercise (HIIE) at 30, 90 and 150 minutes into the intervention.
In each exercise bout, they will cycle at 90% peak power for 3 x 60 second periods with 75 seconds of recovery in-between.
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Breaking up a prolonged bout of sitting in adolescents using high intensity interval exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Popliteal macrovascular function
Time Frame: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
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Flow mediated dilation will be used to assess changes in microvascular function of the popliteal artery
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Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular function in the capillaries of the calf
Time Frame: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
|
Microvascular function will be assessed using post occlusive reactive hyperaemia via laser Doppler flowmetry
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Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
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Changes in plasma triglyceride concentration from a capillary sample
Time Frame: 6.5 hours
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Changes in plasma triglyceride concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal
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6.5 hours
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Changes in plasma insulin concentration from a capillary sample
Time Frame: 6.5 hours
|
Changes in plasma insulin concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal
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6.5 hours
|
Changes in plasma glucose concentration from a capillary sample
Time Frame: 6.5 hours
|
Changes in plasma glucose concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal
|
6.5 hours
|
Blood pressure
Time Frame: 6.5 hours
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Changes in blood pressure will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period
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6.5 hours
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Heart rate
Time Frame: 6.5 hours
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Changes in heart rate will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period
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6.5 hours
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Calf circumference
Time Frame: 6.5 hours
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Calf circumference will be monitored every hour throughout experimental visit to give an indication of venous pooling that may occur as a result of the prolonged sitting and be implicated in the potential decline in vascular function
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6.5 hours
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Physical activity prior to the experimental visits
Time Frame: 48 hours prior to each visit
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Participants will wear GENEactiv accelerometers to monitor their physical activity levels before the experimental visit
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48 hours prior to each visit
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Sitting time during the experimental visits
Time Frame: 6 hours
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Participants will wear an activPAL accelerometer on their thigh to quantify the amount of time they spend sitting, standing and cycling during the trials
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6 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Enjoyment During the High Intensity Interval Exercise
Time Frame: 3 hours
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The enjoyment of the high intensity interval exercise will be assessed during the exercise bouts using the Exercise Enjoyment Scale (ESS) (Stanley & Cumming, 2010).
The scale runs from 1 (not at all) to 7 (extremely) so a larger score indicates greater enjoyment.
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3 hours
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Participant Enjoyment Post the High Intensity Interval Exercise
Time Frame: 3 hours
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Participants will rate their enjoyment post exercise using the Physical Activity Enjoyment Scale (PACES) modified for adolescents (Motl et al., 2001).
Participants rate how much they agree (1 = "disagree a lot" to 5 = "agree a lot") with 16 statements about their feelings from the exercise.
The combined enjoyment scale score can range from 16 to 80 with a higher score indicating greater perceived enjoyment.
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3 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan Barker, PhD, University of Exeter
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 191204/B/04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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