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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04337385
Other study ID # 191204/B/04
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 4, 2020
Est. completion date March 13, 2020

Study information

Verified date May 2021
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate the effect of interrupting a three hour bout of prolonged sitting with high intensity interval exercise on lower limb blood vessel function in adolescents before and after a mixed meal challenge.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date March 13, 2020
Est. primary completion date March 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interrupting 3 hours of prolonged sitting with high intensity interval exercise
Breaking up a prolonged bout of sitting in adolescents using high intensity interval exercise
3 hours of prolonged sitting
Participants will be asked to remain seated for 3 hours and refrain from moving their lower limbs

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (2)

Lead Sponsor Collaborator
University of Exeter University of British Columbia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Enjoyment During the High Intensity Interval Exercise 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. 3 hours
Other Participant Enjoyment Post the High Intensity Interval Exercise 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. 3 hours
Primary Popliteal macrovascular function Flow mediated dilation will be used to assess changes in microvascular function of the popliteal artery Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
Secondary Microvascular function in the capillaries of the calf Microvascular function will be assessed using post occlusive reactive hyperaemia via laser Doppler flowmetry Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
Secondary Changes in plasma triglyceride concentration from a capillary sample Changes in plasma triglyceride concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal 6.5 hours
Secondary Changes in plasma insulin concentration from a capillary sample Changes in plasma insulin concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal 6.5 hours
Secondary Changes in plasma glucose concentration from a capillary sample Changes in plasma glucose concentration will be assessed in response to the prolonged or interrupted sitting and after mixed meal 6.5 hours
Secondary Blood pressure Changes in blood pressure will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period 6.5 hours
Secondary Heart rate Changes in heart rate will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period 6.5 hours
Secondary Calf circumference 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 6.5 hours
Secondary Physical activity prior to the experimental visits Participants will wear GENEactiv accelerometers to monitor their physical activity levels before the experimental visit 48 hours prior to each visit
Secondary Sitting time during the experimental visits Participants will wear an activPAL accelerometer on their thigh to quantify the amount of time they spend sitting, standing and cycling during the trials 6 hours
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