Recruiting

AI-Driven Exercise

Sponsor:

The University of Tennessee, Knoxville

Code:

NCT07768670

Conditions

Feasibility Studies

Physical Activity

Mental Health (Depression)

Anxiety

Quality of Life

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Fitness app powered by AI and wearable device

Study Details

Brief summary:

The purpose of this research is to investigate the feasibility, acceptability, appropriateness, and preliminary efficacy of a wearable and artificial intelligence-driven mobile application-based exercise prescription grounded in self-determination theory (SDT) and behavioral change techniques (BCTs) among older adults. As no data exists on the feasibility of AI-driven exercise programs grounded in SDT and multiple BCTs specifically for older adults, this will be a pioneering study to explore the feasibility of wearable and AI-driven exercise program protocols and the rates of acceptance and appropriateness of the exercise prescription intervention among older adults. In addition, this study will test the preliminary efficacy of the intervention on physical activity (PA), mental health, and quality of life. This study follows the National Institute of Health (NIH) stage model, and it represents stage 1b of the NIH stage model, which emphasizes the feasibility and actionable processes for delivering a new health intervention. Specifically, this study will: 1.Evaluate the research protocol feasibility of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs (of goal setting, self-monitoring, graded task, and demonstration) on older adults over 8 weeks 2. Evaluate the acceptability and appropriateness of a wearable, AI-driven, mobile application-based exercise prescription grounded in SDT and BCTs among older adults over 8 weeks. 3. Evaluate the preliminary impact of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs on older adult PA (steps per day and daily duration of light PA and Moderate-vigorous PA), sedentary time, sleep, mental health (depression and anxiety), and quality of life.

Conditions

Feasibility Studies

Physical Activity

Mental Health (Depression)

Anxiety

Quality of Life

Study ID

NCT07768670

Start date

Oct 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Be aged 65 years or older.
  • Own a smartphone (Android or iOS) compatible with study applications.
  • Have reliable access to the internet or Wi-Fi.
  • Demonstrate basic digital literacy sufficient to operate a smartphone (e.g., ability to open applications, navigate simple interfaces, and follow on-screen instructions), with or without initial guidance from the research staff.
  • Be able to safely engage in physical activity, as determined by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) or physician approval if indicated.
  • Report engaging in less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week.
  • Be able to communicate in English sufficiently to complete study procedures and assessments.

Exclusion Criteria:

  • Are younger than 65 years of age.
  • Do not own a compatible smartphone (Android or iOS) or do not have reliable internet/Wi-Fi access.
  • Are deemed unable to safely participate in physical activity based on the screening process (including PAR-Q+, STEADI, and research staff assessment), or do not obtain required physician clearance when indicated.
  • Currently meet or exceed 150 minutes of moderate-to-vigorous physical activity (MVPA) per week.
  • Are unable to communicate in English sufficiently to understand study procedures, provide informed consent, or complete study-related assessments.
  • Have any medical, physical, or cognitive condition that, in the judgment of the research team, would make participation unsafe or prevent completion of study procedures.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single-arm

All participants will be provided the researcher-developed sFitRx fitness application and a Fitbit Flex 2 tracker. sFitRx will provide participants with an established daily and weekly exercise prescription program based on each participant's: (1) daily step goals, (2) previous week's PA, as collected by the Fitbit Flex 2; and (3) current physical conditioning and well-being, as collected by sFitRx. The sFitRx will provide participants with a video demonstration of warm up exercise and all prescribed exercise types, including aerobics, resistance, balance, and flexibility exercises. These exercises follow a graded task BCT. For instance, a participant with a low baseline PA might be prescribed a beginner programs with a base (entry) level of 1.1. However, the sFitRx will progressively modify the individual exercise program based on the % of exercise completed, daily goal and other metrics.

Interventions

Fitness app powered by AI and wearable device

All participants will be provided the researcher-developed sFitRx mHealth application. sFitRx will provide participants with an established daily and weekly exercise prescription program based on each participant's: (1) daily step goals, (2) previous week's PA, as collected by the Fitbit Flex 2; and (3) current physical conditioning and well-being, as collected by sFitRx. The sFitRx will provide participants with a video demonstration of warm up exercise and all prescribed exercise types, including aerobics, resistance, balance, and flexibility exercises. These exercises follow a graded task BCT. The exercise program delivered by the sFitRx app is grounded in self-determination theory, most especially in satisfying the basic psychological needs that drive intrinsic motivation.

Primary outcome measure

  • Recruitment [ Time Frame: Pre-intervention ]
  • Enrollment [ Time Frame: Pre-intervention ]
  • Participant Dropout Rate [ Time Frame: Baseline (week 1) - Follow up (Week 10) ]
  • Retention [ Time Frame: Baseline (week 1) - Follow up (Week 10) ]
  • Adherence [ Time Frame: Baseline (week 1) - Follow up (Week 10) ]
  • Intervention Feasibility, Acceptability, and Appropriateness [ Time Frame: At follow up (week 10) ]

Central Contacts and Locations

Central contacts

John Oginni, MS

8659747971pael@utk.edu

Locations

Kinesiology, Recreation, and Sport Studies (865) 974-3340 krss@utk.edu

Recruiting

Knoxville, Tennessee, United States, 37996-2700

Contacts

John Oginni

(865) 974-3340joginni@vols.utk.edu

More Information

Sponsor

The University of Tennessee, Knoxville

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • AI-based intervention
  • mobile health technology
  • wearable
  • fitness app
  • feasibility study
  • study acceptability and appropriateness
  • older adult
  • age 65 years
  • 60 years

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by The University of Tennessee, Knoxville on 2026-08-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.