- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07810218
Personalized Exercise Recommendations for Chronic Pelvic Pain Using Reinforcement Learning (WorkoutCPP)
WorkoutCPP: A Pilot Series of N-of-1 Trials Evaluating RL-Generated Adaptive Exercise Recommendations for Pelvic Pain Management
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Chronic pelvic pain disorders (CPPDs) are associated with high symptom burden and reduced quality of life. Physical activity (PA) and exercise have emerged as a promising non-pharmacological approach for symptom management. However, optimal exercise type, intensity, and timing for pain management vary substantially across individuals, supporting the need for personalized adaptive approaches (Ensari et al., 2022, Krasny-Pacini et al., 2017). This study will enroll participants will a CPPD diagnosis into a remote, 9-week study to evaluate the feasibility of RL-based personalized exercise to non-personalized, standard recommendations. Enrollment is rolling, with participants entering the study on a continuous basis. Each participant's start date, and their 9-week intervention period, is determined by their baseline interview date. A baseline interview upon enrollment is scheduled with an exercise physiologist to review the participant's initial exercise list and provide exercise safety information, as well as overview use of the study App. Participants can choose to stay in the study for 2 additional weeks to make up any weeks with inadequate adherence. Study outcomes are measured daily over the course of the intervention period. Daily App-based tracking items assess pain and other symptoms, exercise behavior, perceived effect and feedback to the recommendation, menstrual status, and recommendation compliance. Fitbit trackers simultaneously track participants' objectively-estimated PA. A reinforcement learning (RL) agent implemented in Meier et al. 2023 as the middleware platform generates daily personalized exercise recommendations delivered via a research mobile phone application (Hirten et al., 2023, Meier et al., 2023). Participant-reported perceived effect of each exercise recommendation is used by the RL agent to calculate reward. Participants serve as their own controls, allowing for within-person comparison under the two conditions (Krasny-Pacini et al., 2017). Primary outcomes for the study include standard study feasibility metrics (e.g., adherence, retention). Secondary outcomes focus on RL agent performance and learning over time. Participant safety will be monitored throughout the study, in accordance with the institutional review board.
This work was supported by the Digital Health Partnership (DHP), a collaboration between the Hasso Plattner Institute, Data4Life, the Windreich Department of Artificial Intelligence and Human Health, the Hasso Plattner Institute for Digital Health at Mount Sinai, and The Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ipek Ensari, PhD
- Numero di telefono: 631-565-1829
- Email: ipek.ensari@mssm.edu
Backup dei contatti dello studio
- Nome: Gerard M Ona, MD
- Numero di telefono: 347-835-8115
- Email: GerardAnneAprilOna@mssm.edu
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10029
- Reclutamento
- Icahn School of Medicine at Mount Sinai
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Contatto:
- Ipek Ensari, PhD
- Numero di telefono: 631-565-1829
- Email: ipek.ensari@mssm.edu
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Contatto:
- Gerard M Ona, MD
- Numero di telefono: 347-835-8115
- Email: GerardAnneAprilOna@mssm.edu
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Investigatore principale:
- Ipek Ensari
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion criteria:
- Self-reported CPPD (e.g., endometriosis, adenomyosis, fibroids, etc.) based on clinician diagnosis
- Aged 18-55 years.
- Ownership of an iOS or Android smartphone.
- Willingness to self-track daily symptoms, exercise activities, and self-management behaviors using a smartphone research app.
- Willingness to wear an activity tracker for the study duration.
- Willingness to follow exercise recommendations from a smartphone research app, provided no adverse symptoms occur.
- Ability to read and write in English sufficient to understand study materials and communications.
- At least intermittently physically active (e.g., ≥30 minutes of walking twice per week).
Exclusion criteria:
- Absolute contraindications to PA (e.g., recent myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, or uncontrolled severe hypertension, BP ≥180/110 mm Hg).
- More than two "Yes" responses on the Physical Activity Readiness Questionnaire (PAR-Q) (16) without physician clearance.
- Major life events expected during the next 10 weeks (e.g., pregnancy, planned surgery, or extended travel likely to interfere with participation).
- Current or planned pregnancy within the next 6 months.
- Having given birth in the past 6 months or currently nursing.
- Inability to wear an activity tracker or use the app for the study duration.
- Complete inactivity (i.e., <60 minutes of moderate-intensity PA per week).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: RL-based personalized phase
Participants will receive RL-generated personalized exercise recommendations, which are generated using the list from the initial participant intake form indicating their capacity and resources for carrying out various modalities and intensities of physical activity.
The RL agent learns from the participant feedback to update the update the subsequent recommendations.
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Daily exercise recommendations (using type, intensity, and duration) are generated by a contextual bandit reinforcement learning agent, based on the implementation described in Meier et al. 2023.
Recommendations are personalized using each participant's initially generated list of exercises based on their physical ability and resources available, as well as contextual daily factors including pain symptoms, prior exercise compliance, and their feedback to the previous exercise recommendation.
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Comparatore attivo: Standard (Generic) Exercise Arm
Participants will receive standardized, non-personalized exercise recommendations based on the U.S. Physical Activity Guidelines, in 2-week blocks.
This comparison will serve as the "active control" arm to which the experimental RL arm will be compared.
This type of control condition was selected to provide a more rigorous test of the experimental condition.
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Participants receive exercise recommendations from a standardized, set list of exercise recommendations that are based on USDHHS physical activity guidelines (Piercy et al., 2020).
Recommendations are not personalized based on participant contextual information and do not adapt over the course of the study.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Exercise Recommendation Adherence Rate
Lasso di tempo: At 9 weeks at study completion
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Exercise recommendation adherence rate is calculated by the proportion of daily exercise recommendations completed over the course of the intervention.
A higher exercise adherence rate indicates that participants are completing their given exercise recommendations at higher frequencies.
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At 9 weeks at study completion
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Participant Retention Rate
Lasso di tempo: At 9 weeks at study completion
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Participant retention rate is the proportion of enrolled participants completing study participation until the end of intervention.
A higher retention rate indicates that participants complete the 9-week intervention period at higher frequencies.
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At 9 weeks at study completion
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reinforcement Learning Agent Action Entropy Over Time
Lasso di tempo: At 9 weeks at study completion
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Entropy of the reinforcement learning (RL) agent's action probability distributions is calculated at each decision point throughout the study period.
Entropy ranges from a minimum of 0 (the agent selects a single action with certainty) to a maximum of log(K), where K is the number of distinct recommendation actions available to the agent at that decision point (maximum entropy occurs when the agent assigns equal probability to all available actions).
Decreasing entropy over time indicates increasing model confidence and more consistent personalized recommendation patterns.
Higher entropy indicates greater uncertainty in the agent's decision making.
This outcome will be evaluated for the entire duration of the intervention based on the daily data.
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At 9 weeks at study completion
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Ipek Ensari, PhD, Icahn School of Medicine at Mount Sinai
- Investigatore principale: Stefan Konigorski, PhD, Department of Computational Precision Nutrition, German Institute of Human Nutrition
Pubblicazioni e link utili
Pubblicazioni generali
- Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854.
- Ensari I, Lipsky-Gorman S, Horan EN, Bakken S, Elhadad N. Associations between physical exercise patterns and pain symptoms in individuals with endometriosis: a cross-sectional mHealth-based investigation. BMJ Open. 2022 Jul 18;12(7):e059280. doi: 10.1136/bmjopen-2021-059280.
- Hirten RP, Danieletto M, Landell K, Zweig M, Golden E, Orlov G, Rodrigues J, Alleva E, Ensari I, Bottinger E, Nadkarni GN, Fuchs TJ, Fayad ZA. Development of the ehive Digital Health App: Protocol for a Centralized Research Platform. JMIR Res Protoc. 2023 Nov 16;12:e49204. doi: 10.2196/49204.
- Rabbi M, Aung MS, Gay G, Reid MC, Choudhury T. Feasibility and Acceptability of Mobile Phone-Based Auto-Personalized Physical Activity Recommendations for Chronic Pain Self-Management: Pilot Study on Adults. J Med Internet Res. 2018 Oct 26;20(10):e10147. doi: 10.2196/10147.
Collegamenti utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Dolore
- Manifestazioni neurologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Endometriosi
- Dolore pelvico
- Attività motoria
Altri numeri di identificazione dello studio
- STUDY-23-00721
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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