Physical ActivityAICOCARFITNCT07813312
AI-Supported Digital Coaching And Cardiorespiratory Fitness In Male University Students
A study testing AI-supported digital coaching with Samsung Health-based activity monitoring and Standard Samsung Health activity monitoring in people with Physical Activity and Cardiorespiratory Fitness, run by Transilvania University of Brasov at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Cardiorespiratory Fitness
- What is being tested?
- AI-supported digital coaching with Samsung Health-based activity monitoring and Standard Samsung Health activity monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteRomania
- Study dates
- 5 Mar 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of AI-Supported Digital Coaching With Samsung Health-Based Activity Monitoring On Cardiorespiratory Fitness And Physical Activity in Male University Students
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.
Read the detailed description
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.
- Conditions
- Physical Activity, Cardiorespiratory Fitness
- Being tested
- AI-supported digital coaching with Samsung Health-based activity monitoring, Standard Samsung Health activity monitoring
- Keywords
- Artificial Intelligence, Digital Health, Male University Students, Samsung Health, Wearable Technology, Digital Coaching, Physical Activity, Cardiorespiratory Fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-supported digital coaching with Samsung Health-based activity monitoringBehavioural
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.
Standard Samsung Health activity monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Samsung Health activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 10 weeks after baseline (final assessment)
Secondary outcomes (1)
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.
Measured: Daily for 68 days (approximately 10 weeks), summarized by study week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Mar 2026
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transilvania University of Brasov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Alecu, Ph.D, Principal investigator, Universitatea Tranilvania din Brasov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813312
- Sponsor's protocol ID
- FEFSM-AI-2026-03
- Other IDs
- 491/02.03.2026
- Acronym
- AICOCARFIT
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of AI-Supported Digital Coaching With Samsung Health-Based Activity Monitoring On Cardiorespiratory Fitness And Physical Activity in Male University Students
- ClinicalTrials.gov ID
- NCT07813312
- Acronym / sponsor ID
- AICOCARFIT / FEFSM-AI-2026-03
- Conditions
- Physical Activity, Cardiorespiratory Fitness
- Keywords
- Artificial Intelligence, Digital Health, Male University Students, Samsung Health, Wearable Technology, Digital Coaching, Physical Activity, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Transilvania University of BrasovUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AI-supported digital coaching | Experimental | Behavioral: AI-supported digital coaching with Samsung Health-based activity monitoringParticipants 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. |
| Standard Samsung Health monitoring | Active comparator | Behavioral: Standard Samsung Health activity monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-supported digital coaching with Samsung Health-based activity monitoringParticipants 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. | Behavioural | AI-supported digital coaching |
| Standard Samsung Health activity monitoringParticipants 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. | Behavioural | Standard Samsung Health monitoring |
Primary outcome
Estimated maximal oxygen uptake (VO₂max) derived from the Cooper 12-minute test
Time frame: Approximately 10 weeks after baseline (final assessment)
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.
1 secondary outcome
Mean daily step count by study week
Time frame: Daily for 68 days (approximately 10 weeks), summarized by study week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Alecu, Ph.D principal investigator
Universitatea Tranilvania din Brasov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-supported digital coaching with Samsung Health-based activity monitoring and Standard Samsung Health activity monitoring in people with Physical Activity and Cardiorespiratory Fitness, run by Transilvania University of Brasov at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated maximal oxygen uptake (VO₂max) derived from the Cooper 12-minute test (time frame: Approximately 10 weeks after baseline (final assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.