Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

AI-Based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study

18 agosto 2026 aggiornato da: The University of Tennessee, Knoxville

Artificial Intelligence-based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

By the late 2070s, the global population aged 65 and older is projected to reach 2.2 billion, surpassing the number of children under age 18. In 2020, about 1 in 6 people in the United States (U.S) were age 65 and over, compared to less than 1 in 20 in 1920. The number of U.S. adults 65 years and over is projected to increase to 82 million by 2050, with the older group's share of the total population projected to rise to 23%. Ageing brings about an increased vulnerability to mental health challenges, and chronic conditions such as heart disease, cancer, diabetes, and Alzheimer's. Among adults ages 65 and older, more than 90% have at least one chronic condition and 88% have at least one multiple chronic condition. Chronic conditions contribute to over 75% of healthcare expenditures for individuals aged 65 and above in the U.S, amounting to over $1.5 trillion. An active lifestyle reduces the likelihood of developing chronic diseases and also enhances the overall health outcomes of the older adult population. Despite these benefits, a majority of older adults fail to meet the recommended U.S. physical activity guidelines (150 minutes of moderate intensity PA a week).

Mobile health (mHealth) technologies-such as smartphone applications (apps), wearables, and other mobile devices-have emerged as an increasingly adopted tool for promoting health among older adults. Several studies have demonstrated the potential of mHealth technologies to increase PA, reduce sedentary time, and improve health outcomes. However, findings have shown that the sustainability of mHealth-based exercise interventions remains uncertain. Recent reviews also emphasized the need for more personalized, adaptable mHealth solutions tailored to older adults' unique health conditions and physical ability to ensure better engagement and more durable behavior change. While recent studies show that personalized mHealth-based exercise programs outperform one-size-fits-all approaches, yet their impact is constrained by insufficient personalization data, low adherence, limited scalability, and inadequate integration of behavior-change techniques (BCTs).

Emerging evidence suggests that Artificial Intelligence (AI) can enhance PA. Integrating AI with mHealth tools-such as smartphone apps and wearable devices grounded in BCTs-offers a promising pathway to deliver an automated exercise program tailored to each person's PA goals, health status, and overall well-being, reaching many people at once with the potential of helping older adults adhere longer to an active lifestyle. Such an approach aligns with the growing emphasis on precision health and scalable interventions for aging populations. Despite this promise, the feasibility, acceptability, appropriateness and preliminary impact of an AI-driven, personalized exercise program delivered through mHealth and grounded in SDT and BCTs on older adults' PA and health outcomes remain unexplored.

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: John Oginni, MS
  • Numero di telefono: 8659747971
  • Email: pael@utk.edu

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37996-2700
        • Reclutamento
        • Kinesiology, Recreation, and Sport Studies (865) 974-3340 krss@utk.edu
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment
Lasso di tempo: Pre-intervention
Number screened/month per recruitment method
Pre-intervention
Enrollment
Lasso di tempo: Pre-intervention
Number excluded by criterion; Number that decline participation; Reason for declining participation (open-ended); Average time from screening to enrollment (minutes/hours/days/month).
Pre-intervention
Participant Dropout Rate
Lasso di tempo: Baseline (week 1) - Follow up (Week 10)
Number dropouts from AI-based exercise intervention; Reason for dropout (open-ended).
Baseline (week 1) - Follow up (Week 10)
Retention
Lasso di tempo: Baseline (week 1) - Follow up (Week 10)
Number that completed the intervention program
Baseline (week 1) - Follow up (Week 10)
Adherence
Lasso di tempo: Baseline (week 1) - Follow up (Week 10)
Percentage of the exercise program completed weekly (%)
Baseline (week 1) - Follow up (Week 10)
Intervention Feasibility, Acceptability, and Appropriateness
Lasso di tempo: At follow up (week 10)
Intervention Feasibility (ease of delivery). will be assessed using the Weiner et al. (2017)1 validated questionnaire for the feasibility of intervention measure (FIM). This questionnaire contains 4-item questions on a 5-point Likert scale (completely disagree [1]-completely agree [5]), with a score range of 1-5. Intervention Acceptability (assessing participant satisfaction). will be obtained after the intervention (8 weeks) on a 1-5 Likert scale of 4-item questions, including "The exercise program delivered by the app meets my approval" using the Acceptability of Intervention Measure (AIM) by Weiner et al., 20171. Appropriateness (perceived fit for rural older adults). will be assessed using the Weiner et al., 20171 intervention appropriateness measure (IAM). The IAM is on 1-5 Likert scale of 4-item questions, including "The exercise program seems fitting", "The exercise program seems suitable". The AIM and IAM are robust, with Cronbach alphas of 0.89 and 0.87, respectively.
At follow up (week 10)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fitbit Daily Step
Lasso di tempo: Baseline (week 0) and Follow up (week 10)
Fitbit Flex 2 will be used to assess participants' daily steps
Baseline (week 0) and Follow up (week 10)
Physical Activity
Lasso di tempo: Baseline (week 1) and Follow up (Week 10)
We will use the Physical Activity Scale for the Elderly to assess PA across leisure (6-item question), household (3-item question), and occupational domains (1-item question) over the past 7 days. Higher scores means more physical activity. (Low activity: <100; Moderate: 100-250; High: >250)
Baseline (week 1) and Follow up (Week 10)
Depression
Lasso di tempo: Baseline (week 0) and Follow up (week 10)

Depression will be measured using Patient Health Questionnaire (PHQ-8), a 8-item symptom severity rating scale for depression (Kroenke et al., 2009). PHQ-8 is a validated diagnostic and severity measure of symptoms of depressive disorders.

Adults with scores of 0-4 are considered to have no or minimal symptoms of depression.

Score 5-9 are considered mild symptom Score 10-14 are considered moderate symptom Score 15-24 are considered severe symptom
Baseline (week 0) and Follow up (week 10)
Anxiety
Lasso di tempo: Baseline (week 0) and Follow up (week 10)

Anxiety will be assessed using the Geriatric Anxiety Scale (GAS). GAS is a 10-item rating scale on a 4-Likert Scale (Not at all [0] to All of the time [3]). Item 1 through 10 are summed to provide a total score. The higher the score, the worse the anxiety outcome.

Score 1-6 are considered minimal symptom Score 7-9 are considered mild symptom Score 10 is considered moderate Score 12-30 are considered severe symptom
Baseline (week 0) and Follow up (week 10)
Older Adult Quality of Life
Lasso di tempo: Baseline (week 0) and Follow up (week 10)

Quality of life (QoL) will be assessed using the Older Adult Quality of Life Scale.

Each of the 13 items is scored Strongly agree=1, Agree=2, Neither=3, Disagree=4, Strongly disagree=5. The items are summed for a total OPQOL-Brief score, then positive items are reverse coded, so that higher scores represented higher QoL.

Minimum: 13 (very poor quality of life) Maximum: 65 (excellent quality of life)
Baseline (week 0) and Follow up (week 10)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Tennessee, Knoxville

Investigatori

  • Investigatore principale: Zan Gao, PhD, University Of Tennessee,knoxville

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

20 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

3 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 agosto 2026

Primo Inserito (Effettivo)

17 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00000770

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi