MOReS Freestyle Libre Validation Study

Sponsor
Oxford Brookes University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04989712
Collaborator
(none)
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Study Details

Study Description

Brief Summary

To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure
N/A

Detailed Description

Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.

Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomised cross over design. Participants act as own controls.Randomised cross over design. Participants act as own controls.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Impact of Different Exercise Timings on Blood Glucose Control and Cognition in Children and Adolescents Using the Freestyle Libre Continuous Glucose Monitoring System
Anticipated Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20 minutes MVPA

20 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 40 minutes from the start of the testing session following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point.

Other: Exposure
Participants randomised to one of the three exposures

Experimental: 4 x 5 mins MVPA

4 bouts of 5 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 30 minutes from the start of the testing session and repeated at 60 mins, 90 mins and 120 mins following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point.

Other: Exposure
Participants randomised to one of the three exposures

Experimental: Uninterrupted sitting - No exercise, sitting session (control).

A sitting only exposure, glucose solution to be consumed at 0 mins.Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point

Other: Exposure
Participants randomised to one of the three exposures

Outcome Measures

Primary Outcome Measures

  1. Executive Functioning - Eriksen Flanker Task [Maximum of two weeks]

    The main outcome will be change in executive functioning from the start to the end of the session using the Eriksen Flanker Task. The test measures selective attention and executive control and measures speed (milliseconds) and accuracy (number of responses correct). This will be performed before the oral glucose tolerance test and again at the end of each session.

  2. Working Memory - WISC Digit Span [Maximum of two weeks]

    Wechsler Intelligence Scale for Children (WISC) Digit Span will test attention and working memory. The total score is calculated by the number of correct responses. This will be performed before the oral glucose tolerance test and again at the end of each session.

Secondary Outcome Measures

  1. Oral Glucose Tolerance Test (OGTT) [Maximum of two weeks]

    On arrival an OGTT, simulating insulin and glucose response comparable to that following a meal will be given. Children will follow an identical protocol for OGTT during all conditions. Children will be asked to fast the night before, for 10 hours prior to the test. They will arrive fasted, have a baseline glucose reading taken and will be given the OGTT, followed by sit only or sit in addition to physical activity breaks regimens. For the OGTT the stimulus is 1.75g/kg body weight of glucose solution. A Freestyle Libre glucose monitoring system will be placed on the participants' arm and glucose readings will be monitored at timed intervals.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Young people aged 9-18 years old

  • No significant current or previous medical history

  • Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)

Exclusion Criteria:
  • Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication > 12 weeks)

  • Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions

  • Those who experience contraindications to physical training

  • Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)

  • Those with known allergies to plasters

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford Brookes University Oxford Oxfordshire United Kingdom OX3 0BP

Sponsors and Collaborators

  • Oxford Brookes University

Investigators

  • Principal Investigator: Helen Dawes, PhD, Oxford Brookes University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helen Dawes, Professor of Movement Science, Director Centre for Movement and Occupational Rehabilitation Sciences, Oxford Brookes University
ClinicalTrials.gov Identifier:
NCT04989712
Other Study ID Numbers:
  • LGHC072021
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Helen Dawes, Professor of Movement Science, Director Centre for Movement and Occupational Rehabilitation Sciences, Oxford Brookes University

Study Results

No Results Posted as of Aug 4, 2021