Cardiovascular Risk FactorNCT04337385
Interrupting Sitting With High Intensity Exercise on Vascular Function in Adolescents Before and After a Mixed Meal
A study testing Interrupting 3 hours of prolonged sitting with high intensity interval exercise and 3 hours of prolonged sitting in people with Cardiovascular Risk Factor and Endothelial Dysfunction, run by University of Exeter at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Endothelial Dysfunction
- What is being tested?
- Interrupting 3 hours of prolonged sitting with high intensity interval exercise and 3 hours of prolonged sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2020to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female adolescents
- 12-15 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Interrupting 3 hours of prolonged sitting with high intensity interval exercise, 3 hours of prolonged sitting
- Keywords
- Flow mediated dilation, Reactive hyperaemia, Endothelial function, Paediatrics, Physical inactivity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupting 3 hours of prolonged sitting with high intensity interval exerciseBehavioural
Breaking up a prolonged bout of sitting in adolescents using high intensity interval exercise
3 hours of prolonged sittingBehavioural
Participants will be asked to remain seated for 3 hours and refrain from moving their lower limbs
| Study group | Role | What they receive |
|---|---|---|
| 3 hours of Prolonged Sitting | Experimental | Participants will sit continuously for three hours before receiving a mixed meal challenge. Receives: Behavioral: 3 hours of prolonged sitting |
| 3 hours of interrupted sitting with hourly HIIE | Experimental | 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. Receives: Behavioral: Interrupting 3 hours of prolonged sitting with high intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Popliteal macrovascular function
Flow mediated dilation will be used to assess changes in microvascular function of the popliteal artery
Measured: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
Secondary outcomes (9)
Microvascular function in the capillaries of the calf
Microvascular function will be assessed using post occlusive reactive hyperaemia via laser Doppler flowmetry
Measured: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
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
Measured: 6.5 hours
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
Measured: 6.5 hours
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
Measured: 6.5 hours
Blood pressure
Changes in blood pressure will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period
Measured: 6.5 hours
Heart rate
Changes in heart rate will be monitored hourly throughout the 3 hour sitting period and three hour postprandial period
Measured: 6.5 hours
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
Measured: 6.5 hours
Physical activity prior to the experimental visits
Participants will wear GENEactiv accelerometers to monitor their physical activity levels before the experimental visit
Measured: 48 hours prior to each visit
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start4 Mar 2020
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: COVID-19 resulted in laboratory closures and the student has changed their research project in order to progress in their degree.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Alan Barker, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337385
- Sponsor's protocol ID
- 191204/B/04
- Status last verified
- May 2021
- First submitted
- 30 Mar 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04337385
- Acronym / sponsor ID
- 191204/B/04
- Keywords
- Flow mediated dilation, Reactive hyperaemia, Endothelial function, Paediatrics, Physical inactivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 resulted in laboratory closures and the student has changed their research project in order to progress in their degree.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 hours of Prolonged Sitting | Experimental | Behavioral: 3 hours of prolonged sittingParticipants will sit continuously for three hours before receiving a mixed meal challenge. |
| 3 hours of interrupted sitting with hourly HIIE | Experimental | Behavioral: Interrupting 3 hours of prolonged sitting with high intensity interval exerciseParticipants 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female adolescents
- 12-15 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interrupting 3 hours of prolonged sitting with high intensity interval exerciseBreaking up a prolonged bout of sitting in adolescents using high intensity interval exercise | Behavioural | 3 hours of interrupted sitting with hourly HIIE |
| 3 hours of prolonged sittingParticipants will be asked to remain seated for 3 hours and refrain from moving their lower limbs | Behavioural | 3 hours of Prolonged Sitting |
Primary outcome
Popliteal macrovascular function
Time frame: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period
Flow mediated dilation will be used to assess changes in microvascular function of the popliteal artery
9 secondary outcomes
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
Changes in plasma triglyceride concentration from a capillary sample
Time frame: 6.5 hours
Changes in plasma insulin concentration from a capillary sample
Time frame: 6.5 hours
Changes in plasma glucose concentration from a capillary sample
Time frame: 6.5 hours
Blood pressure
Time frame: 6.5 hours
Heart rate
Time frame: 6.5 hours
Calf circumference
Time frame: 6.5 hours
Physical activity prior to the experimental visits
Time frame: 48 hours prior to each visit
Sitting time during the experimental visits
Time frame: 6 hours
Results and safety
The study was stopped early (reason given: COVID-19 resulted in laboratory closures and the student has changed their research project in order to progress in their degree.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Barker, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupting 3 hours of prolonged sitting with high intensity interval exercise and 3 hours of prolonged sitting in people with Cardiovascular Risk Factor and Endothelial Dysfunction, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 resulted in laboratory closures and the student has changed their research project in order to progress in their degree.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal macrovascular function (time frame: Before and after 3 hours of prolonged vs. interrupted sitting and after a subsequent 3 hour postprandial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.