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Personalized Exercise Recommendations for Chronic Pelvic Pain Using Reinforcement Learning (WorkoutCPP)

3 września 2026 zaktualizowane przez: Ipek Ensari, Icahn School of Medicine at Mount Sinai

WorkoutCPP: A Pilot Series of N-of-1 Trials Evaluating RL-Generated Adaptive Exercise Recommendations for Pelvic Pain Management

WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs). The study uses reinforcement learning (RL), a type of artificial intelligence that adapts recommendations over time based on each participant's reported pain levels, symptom burden, and exercise compliance. Participants receive daily exercise recommendations that alternate between standard, non-personalized guidance and personalized, RL-generated recommendations across four 2-week phases, allowing within-person comparison of outcomes under each condition. The primary hypothesis is that an RL-based adaptive recommendation system is feasible to deliver in a CPPD population.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

45

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • Rekrutacyjny
        • Icahn School of Medicine at Mount Sinai
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Ipek Ensari

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.
Aktywny komparator: 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.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Exercise Recommendation Adherence Rate
Ramy czasowe: At 9 weeks at study completion
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.
At 9 weeks at study completion
Participant Retention Rate
Ramy czasowe: At 9 weeks at study completion
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.
At 9 weeks at study completion

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Reinforcement Learning Agent Action Entropy Over Time
Ramy czasowe: At 9 weeks at study completion
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.
At 9 weeks at study completion

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Ipek Ensari, PhD, Icahn School of Medicine at Mount Sinai
  • Główny śledczy: Stefan Konigorski, PhD, Department of Computational Precision Nutrition, German Institute of Human Nutrition

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 lutego 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2027

Ukończenie studiów (Szacowany)

1 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

3 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 września 2026

Pierwszy wysłany (Rzeczywisty)

9 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared, in order to protect participant privacy and confidentiality, consistent with the IRB guidelines and informed consent form under which participants were enrolled.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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