NCT04337385

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

9 days

First QC Date

March 30, 2020

Last Update Submit

May 20, 2021

Conditions

Cardiovascular Risk FactorEndothelial Dysfunction

Keywords

Flow mediated dilationReactive hyperaemiaEndothelial functionPaediatricsPhysical inactivity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Microvascular function in the capillaries of the calf

    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

    6.5 hours

  • Changes in plasma insulin concentration from a capillary sample

    6.5 hours

  • Changes in plasma glucose concentration from a capillary sample

    6.5 hours

  • Blood pressure

    6.5 hours

  • +4 more secondary outcomes

Other Outcomes (2)

  • Participant Enjoyment During the High Intensity Interval Exercise

    3 hours

  • Participant Enjoyment Post the High Intensity Interval Exercise

    3 hours

Study Arms (2)

3 hours of Prolonged Sitting

EXPERIMENTAL

Participants will sit continuously for three hours before receiving a mixed meal challenge.

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.

Behavioral: Interrupting 3 hours of prolonged sitting with high intensity interval exercise

Interventions

Interrupting 3 hours of prolonged sitting with high intensity interval exerciseBEHAVIORAL

Breaking up a prolonged bout of sitting in adolescents using high intensity interval exercise

3 hours of interrupted sitting with hourly HIIE
3 hours of prolonged sittingBEHAVIORAL

Participants will be asked to remain seated for 3 hours and refrain from moving their lower limbs

3 hours of Prolonged Sitting

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female adolescents
  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alan Barker, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 7, 2020

Study Start

March 4, 2020

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

GB(1)