MOReS Freestyle Libre Validation Study

Oxford Brookes University

Status: Enrolling

Conditions: Cognitive Change; Blood Glucose; Executive Function

Treatments: Other: Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT04989712

LGHC072021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

20 minutes MVPA

Experimental group

Description:

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.

Treatment:

Other: Exposure

4 x 5 mins MVPA

Experimental group

Description:

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.

Treatment:

Other: Exposure

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

Experimental group

Description:

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

Treatment:

Other: Exposure