Trial · NCT07885644
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distance per scheduled minute (km/min) recorded by the stationary-bike software on each riding day | Up to 8 weeks | 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. |
| Secondary | 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 | Mean of sensor readings over the final 60 s, also as % of age-predicted maximum (208 - 0.7 × age). Rides included only if sensor coverage ≥ 80% with no gap \> 60 s. Higher values indicate higher intensity. |
| Secondary | Minutes per riding day in the target heart-rate zone, measured by an arm-worn optical heart-rate sensor | Up to 8 weeks | Minutes with heart rate between 60% and 80% of age-predicted maximum, summed across rides on a riding day; range 0-10. Used to compare received intensity between one 10-min ride and two 5-min rides. |
| Secondary | Affect during the ride, measured by the Feeling Scale | Up to 8 weeks | Single-item Feeling Scale (Hardy \& Rejeski, 1989), -5 (very bad) to +5 (very good), reported by pointing to a pictorial card at minute 5 of a 10-min ride and minute 2.5 of each 5-min ride. Higher scores indicate more positive affect. |
| Secondary | Affect after the ride, measured by the Feeling Scale | Up to 8 weeks | Single-item Feeling Scale, -5 (very bad) to +5 (very good), completed privately on a tablet. Higher scores indicate more positive affect. |
| Secondary | Post-ride enjoyment score on a study-specific 0-10 numeric rating item | Up to 8 weeks | "How much did you like this ride", 0 (not at all) to 10 (very much). Higher scores indicate greater enjoyment. |
| Secondary | Perceived exertion after the ride, measured by the OMNI Bike Scale for children | Up to 8 weeks | Perceived exertion is assessed within 5 minutes after each ride using the OMNI Bike Scale for children (Robertson et al., 2000), a pictorial 0-10 scale showing a child cycling up an increasingly steep hill. Scores range from 0 (extremely easy) to 10 (extremely hard). Higher scores indicate greater perceived exertion. The scale is presented on a tablet with the standard pictorial anchors and Chinese translations of the verbal anchors; children respond by pointing or tapping, with the item read aloud by study staff if needed. |
| Secondary | Perceived competence and perceived pressure scores on two study-specific 0-10 numeric rating items | Up to 8 weeks | Competence: "How well did you ride today", 0-10, higher = greater competence. Pressure: "Did you feel pushed to ride", 0-10, higher = greater pressure. Reported separately. |
| Secondary | Proportion of intervals on-task in a 20-minute classroom window after riding, measured by momentary time sampling by blinded observers | Up to 8 weeks | Proportion (0-1) of 10-s intervals coded on-task in the classroom window beginning at 14:05 on each riding day, and at 10:40 on two-ride days, for riders who rode that day and their waitlist classmates. Fixed observer pool unaware of allocation and display; 20% of windows double-coded. Higher = more on-task. |
| Secondary | Percentage of scheduled riding opportunities offered, attended, refused, stopped early and completed, from the study attendance log | Up to 8 weeks | Offered and attended use all scheduled opportunities as denominator; refused, stopped early and completed use offered-and-present opportunities. Unit: %. |
| Secondary | Percentage of rides rated more enjoyable, about the same, or less enjoyable than the previous ride, on a study-specific three-category item | Up to 8 weeks | Three categories; reported as % of rides in each category by display and schedule. Not applicable on the first ride; on two-ride days "previous ride" is the earlier ride that day. |
| Secondary | Change in exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-2, children's version (C-BREQ-2) | Baseline and week 9 | 18 items in five subscales (amotivation, external, introjected, identified, intrinsic regulation), each item scored 0 (not true for me) to 4 (very true for me); subscale score is the item mean (0-4). Higher intrinsic and identified scores indicate more autonomous motivation (better); higher amotivation and external scores indicate less autonomous motivation (worse). |
| Secondary | Change in health-related quality of life measured by the KIDSCREEN-10 Index | Baseline and week 9 | 10 items scored 1-5, sum 10-50 converted to T-score (mean 50, SD 10). Higher = better. Pilot estimate, riding vs waitlist. |
| Secondary | Change in inhibitory control measured by the Flanker task reverse-coded reaction-time interference score | Baseline and week 9 | A computerised Flanker task administered on a tablet (PsyToolkit). For each participant, mean reaction time (milliseconds) is computed for correct congruent and incongruent trials; the reverse-coded interference score is mean congruent minus mean incongruent reaction time, so that higher scores indicate better inhibitory control. Accuracy (%) is reported alongside. |
| Secondary | Facial Expression Valence Index From Camera-Based Facial Expression Recognition | Up to 8 weeks | percentage points, calculated for each ride as the percentage of valid camera samples classified as happy minus the percentage classified as sad, angry, fearful, disgusted or contemptuous; range -100 to 100, with higher values indicating more positive facial expression. Measurement tool: camera-based facial expression recognition system mounted above the bike screen, which classifies each sample of the rider's face as neutral, happy, sad, angry, surprised, fearful, disgusted or contemptuous; only these classifications are stored. The percentage of samples in each category is also reported. |
| Other | Number of adverse events and serious adverse events from the study safety log | Up to 8 weeks | Counts by type. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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