An interventional study of AI-supported digital coaching with Samsung Health-based activity monitoring and Standard Samsung Health activity monitoring in Physical Activity and Cardiorespiratory Fitness, sponsored by Transilvania University of Brasov. Completed at 1 site in Romania. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Transilvania University of Brasov · Not applicable, Interventional, and Other
This study evaluated whether AI-supported digital coaching combined with Samsung Health-based activity monitoring could improve cardiorespiratory fitness and physical activity in male university students compared with standard Samsung Health monitoring.
In this single-center randomized controlled trial, 312 male university students were assigned in a 1:1 ratio to approximately 10 weeks of either AI-supported digital coaching or standard activity monitoring. The AI-supported intervention provided adaptive daily step goals, activity coaching, progress feedback, and recovery recommendations based on recent activity, while the control group used standard monitoring without AI-supported coaching.
The primary outcome was estimated maximal oxygen uptake (VO2max) derived from the Cooper 12-minute test. Physical activity was also evaluated using daily step counts collected through the study activity-monitoring workflow.
This was a single-center, parallel-group randomized controlled trial conducted at Transilvania University of Brașov, Romania. Participants meeting the study-defined semi-active criteria were randomized 1:1 to AI-supported digital coaching or standard Samsung Health-based activity monitoring.
The experimental intervention combined activity monitoring with adaptive digital coaching. Coaching outputs included personalized daily step targets, activity coaching and goal adjustment, weekly progress summaries, and recovery or rest-day recommendations based on recent activity. Android participants received the configured intervention through the research Samsung Health environment. For participants using iOS devices, activity data were incorporated through the study workflow using Apple HealthKit where necessary, and equivalent coaching was delivered through a research-administered web dashboard.
Participants in the control group used standard Samsung Health monitoring, including step counting, activity displays, and generic weekly reports, without the research-configured AI-supported coaching. No study-provided individualized exercise program was delivered to either group.
Cardiorespiratory fitness was assessed using estimated VO2max derived from distance completed during the Cooper 12-minute test. Physical activity was monitored using daily step counts. The trial was designed to compare cardiorespiratory fitness and physical-activity trajectories between the randomized groups.
Exclusion Criteria:
Participants received Samsung Health-based activity monitoring combined with research-configured AI-supported digital coaching for approximately 10 weeks. Coaching included adaptive daily step targets, real-time coaching and goal adjustment, weekly progress summaries and insight cards, and recovery or rest-day recommendations based on recent activity. Android participants received the configured functions through the research Samsung Health environment; iOS participants received equivalent coaching through a research-administered web dashboard.
Behavioral: AI-supported digital coaching with Samsung Health-based activity monitoring
Participants used standard Samsung Health monitoring for approximately 10 weeks, including step counting, activity rings, and generic weekly reports. Research-configured AI-supported coaching was disabled for the control condition. Research staff provided standardized technical support, but no individualized exercise coaching or study-provided exercise program was delivered.
Behavioral: Standard Samsung Health activity monitoring
Participants received approximately 10 weeks of Samsung Health-based activity monitoring combined with research-configured AI-supported digital coaching. The intervention provided adaptive daily step targets, real-time coaching and goal adjustment, weekly progress summaries and insight cards, and recovery or rest-day recommendations based on recent activity. Android participants received the configured functions through the research Samsung Health environment. For iOS participants, activity data were synchronized through the study workflow using Apple HealthKit where necessary, and equivalent coaching was delivered through a research-administered web dashboard. Research staff provided technical support but did not manually alter AI recommendations or provide individualized exercise coaching.
Participants used standard Samsung Health monitoring for approximately 10 weeks, including step counting, activity rings, and generic weekly reports. Research-configured AI-supported coaching was disabled for the control condition. Research staff provided standardized technical support, but no individualized exercise coaching or study-provided exercise program was delivered.
Estimated maximal oxygen uptake (VO₂max) derived from the Cooper 12-minute test
Cardiorespiratory fitness was assessed using the Cooper 12-minute test on a standard 400-m outdoor track. Participants were instructed to run or walk as far as possible in 12 minutes. Distance was recorded to the nearest 10 m. Estimated VO₂max was calculated as (distance in meters - 504.9) / 44.73 and expressed in mL·kg-¹·min-¹.
Time frame: Approximately 10 weeks after baseline (final assessment)
Mean daily step count by study week
Daily step counts were collected through the study activity-monitoring workflow using Samsung Health and, for iOS participants where necessary, Apple HealthKit. A monitoring day was considered valid when the device recorded at least 10 hours of wear or usage time, the recorded step count was between 100 and 40,000, and no manual-entry flag or device-error code was present. Only valid monitoring days contributed to weekly summaries. Mean daily step counts were summarized by study week and used to evaluate physical-activity trajectories across the monitoring period.
Time frame: Daily for 68 days (approximately 10 weeks), summarized by study week.
Plan to share: Yes — De-identified individual participant-level data underlying the results reported in the publication, together with the analysis code, will be available on reasonable request. Data will be shared only where permitted by participant consent, institutional ethics requirements, and applicable data-protection requirements.
Supporting information: Analytic code
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Transilvania University of Brasov