NCT07885644

Brief Summary

The goal of this pilot clinical trial is to learn how short exercise breaks, often called exercise snacks, on stationary exercise bikes can best be offered during the school day to students in Primary 4 to 6 at an inclusive primary school in Macao, including autistic students. It will also learn whether the program is practical and safe in an inclusive school. The main questions it aims to answer are: When the bike screen shows a game with points and a ranking among the four riders in the group, do students ride farther per scheduled minute than when the same screen shows a regular display with a cartoon cyclist, heart rate, distance and time remaining? Is any extra riding on game days larger when the 10 minutes are ridden at once than when they are split into two 5-minute rides, and is it accompanied by better or worse feelings during and after the ride? When the same 10 minutes are split into two 5-minute rides, do students receive the same riding dose and are they as focused on their classwork afterwards? How many planned rides actually happen and are completed, and what support do autistic students need? The investigators expect students to ride more on game days. Whether that extra riding comes with better or worse feelings, and whether it depends on ride length. The comparison with the waitlist group only estimates how large the differences are, to help plan a larger study. Thirty-two riders ride in fixed groups of four on 3 fixed school days a week for 8 weeks, 10 minutes a day: one 10-minute ride a day for 4 weeks and two 5-minute rides a day for the other 4 weeks. Within each 4-week period, the display shown to a group on each riding day is randomly assigned, with equal numbers of game and regular-display days, and the same virtual tracks are used under both displays. Riders wear a heart-rate arm band and answer a few picture-supported questions before, during and after each ride. Trained observers, who do not know which display or schedule students are on, record how focused students are on their classwork in the lesson after riding. Sixteen waitlist students follow the usual school routine, complete the same assessments, and receive access to the bikes after the study. All students complete a short tablet attention task and questionnaires about exercise motivation and quality of life before and after the 8 weeks.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Oct 2026Dec 2026

First Submitted

Initial submission to the registry

September 27, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 19, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

September 27, 2026

Last Update Submit

October 17, 2026

Conditions

Keywords

Exercise snacksPhysical activity breaksExergamingSpecial educational needsGamification

Outcome Measures

Primary Outcomes (1)

  • Distance per scheduled minute (km/min) recorded by the stationary-bike software on each riding day

    Sum of distance (km) recorded across all study rides on a scheduled riding day, divided by the 10-minute daily budget. Both displays run the same virtual track so the distance algorithm is identical. Refused rides scored 0; days not offered or absent excluded from the denominator; lost measurements treated as missing. Higher values indicate more riding output.

    Up to 8 weeks

Secondary Outcomes (14)

  • Mean heart rate (beats per minute) in the last 60 seconds of each ride, measured by an arm-worn optical heart-rate sensor

    Up to 8 weeks

  • Minutes per riding day in the target heart-rate zone, measured by an arm-worn optical heart-rate sensor

    Up to 8 weeks

  • Affect during the ride, measured by the Feeling Scale

    Up to 8 weeks

  • Affect after the ride, measured by the Feeling Scale

    Up to 8 weeks

  • Post-ride enjoyment score on a study-specific 0-10 numeric rating item

    Up to 8 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • Number of adverse events and serious adverse events from the study safety log

    Up to 8 weeks

Study Arms (3)

Cycling 1: Continuous Schedule First

EXPERIMENTAL

16 riders. Weeks 1 to 4: one 10-minute ride per riding day. Weeks 5 to 8: two 5-minute rides per riding day. Riders ride in a fixed group of four on 3 fixed school days a week for 8 weeks, and the group's screen alternates between the racing game and the regular dashboard across riding days in a randomized order.

Behavioral: Stationary cycling with game displayBehavioral: Stationary cycling with regular displayBehavioral: One 10-minute ride per riding dayBehavioral: Two 5-minute rides per riding day

Cycling 2: Distributed Schedule First

EXPERIMENTAL

16 riders. Weeks 1 to 4: two 5-minute rides per riding day. Weeks 5 to 8: one 10-minute ride per riding day. Riders ride in a fixed group of four on 3 fixed school days a week for 8 weeks, and the group's screen alternates between the racing game and the regular dashboard across riding days in a randomized order.

Behavioral: Stationary cycling with game displayBehavioral: Stationary cycling with regular displayBehavioral: One 10-minute ride per riding dayBehavioral: Two 5-minute rides per riding day

Waitlist

NO INTERVENTION

16 students who follow the usual school routine during the study and complete the same assessments. They receive the same access to the bikes after the study.

Interventions

Riding a stationary exercise bike whose screen shows a video game.

Cycling 1: Continuous Schedule FirstCycling 2: Distributed Schedule First

Riding the same bike with the screen showing only a timer, pedaling rate and heart rate, with no game elements.

Cycling 1: Continuous Schedule FirstCycling 2: Distributed Schedule First

Two 5-minute rides per riding day, about 3 to 5 hours apart, giving the same daily total as the one-ride schedule.

Cycling 1: Continuous Schedule FirstCycling 2: Distributed Schedule First

One 10-minute ride per riding day on 3 fixed school days a week for 8 weeks.

Cycling 1: Continuous Schedule FirstCycling 2: Distributed Schedule First

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Student in Primary 4 to 6 at the participating school
  • Written informed consent from a parent or legal guardian and the student's own assent; students with special educational needs use a pictorial assent procedure
  • Completed parental health screening questionnaire
  • Tall enough to pedal normally with the seat at its lowest position, checked during a trial ride
  • Able to complete 5-minute and 10-minute rides and brief self-ratings with verbal or visual prompts

You may not qualify if:

  • Heart, lung or metabolic disease diagnosed by a physician that requires restriction of physical activity
  • History of photosensitive epilepsy, or seizures of unknown cause
  • Lower-limb injury or surgery in the past 3 months that affects pedaling
  • Unable to get on and off the bike safely, as judged by the physical education teacher and the inclusive-education coordinator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 21, 2026

Study Start

October 19, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share