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

18 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: John Oginni, MS
  • Número de telefone: 8659747971
  • E-mail: pael@utk.edu

Locais de estudo

    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37996-2700
        • Recrutamento
        • Kinesiology, Recreation, and Sport Studies (865) 974-3340 krss@utk.edu
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Recruitment
Prazo: Pre-intervention
Number screened/month per recruitment method
Pre-intervention
Enrollment
Prazo: 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
Prazo: 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
Prazo: Baseline (week 1) - Follow up (Week 10)
Number that completed the intervention program
Baseline (week 1) - Follow up (Week 10)
Adherence
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Fitbit Daily Step
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Zan Gao, PhD, University Of Tennessee,knoxville

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

20 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

3 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de agosto de 2026

Primeira postagem (Real)

17 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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