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

3 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • New York
      • New York, New York, Verenigde Staten, 10029
        • Werving
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Ipek Ensari

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exercise Recommendation Adherence Rate
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reinforcement Learning Agent Action Entropy Over Time
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 februari 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 augustus 2027

Studieregistratiedata

Eerst ingediend

3 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 september 2026

Eerst geplaatst (Werkelijk)

9 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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