NCT07813312

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 3, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Artificial IntelligenceDigital HealthMale University StudentsSamsung HealthWearable TechnologyDigital CoachingPhysical ActivityCardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately 10 weeks after baseline (final assessment)

Secondary Outcomes (1)

  • Mean daily step count by study week

    Daily for 68 days (approximately 10 weeks), summarized by study week.

Study Arms (2)

AI-supported digital coaching

EXPERIMENTAL

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

Standard Samsung Health monitoring

ACTIVE COMPARATOR

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

Interventions

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.

AI-supported digital 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.

Standard Samsung Health monitoring

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male university student.
  • Average of 5,000-7,499 steps/day over the last 14 valid pre-baseline activity-monitoring days available through the study workflow.
  • Self-reported moderate-to-vigorous physical activity of 150-299 minutes/week on the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
  • Completion of the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+); participants with an affirmative response were required to obtain medical clearance before enrollment.
  • Written informed consent provided before baseline assessment and randomization.

You may not qualify if:

  • Did not meet the study-defined semi-active physical-activity criteria, including participants who were already highly active.
  • Medical contraindication to participation or failure to obtain required medical clearance following safety screening.
  • Planned absence of more than 2 weeks during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Transilvania University of Brașov

Brasov, Brașov County, 500036, Romania

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stefan Alecu, Ph.D

    Universitatea Tranilvania din Brasov

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Cooper-test outcome assessors were blinded to randomized group allocation. Participants and the coordinator responsible for digital intervention configuration were not blinded. The statistician responsible for the primary analysis remained blinded to allocation until database lock and finalization of the analysis code.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio to two parallel groups: AI-supported digital coaching with activity monitoring or standard Samsung Health monitoring for approximately 10 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

March 5, 2026

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
Time Frame
Beginning after publication of the primary study results. No fixed end date is currently specified.
Access Criteria
Requests should be directed to the corresponding author and should include a scientifically justified proposal describing the purpose of the requested analyses. Access will be subject to institutional review and ethics approval where required, and execution of an appropriate data-use agreement. Only de-identified data will be provided.

Locations