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Personalized Exercise Recommendations for Chronic Pelvic Pain Using Reinforcement Learning

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810218
Acronym
WorkoutCPP
Enrollment
45
Registered
2026-09-09
Start date
2026-02-06
Completion date
2027-08-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pelvic Pain, Endometriosis, Pelvic Pain

Keywords

Mobile health, Reinforcement learning, Physical activity, N-of-1 trial, exercise, personalized, intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALReinforcement Learning (RL)-Based Personalized Exercise 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.

BEHAVIORALGeneric Exercise Recommendation

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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER
Hasso Plattner Institute, Potsdam, Germany
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants are blinded to their assigned study phase (active control: generic exercise recommendations vs. experimental: RL-generated adaptive recommendations) and are not informed of the phase sequence or their current assignment at any point during the study. However, participants may be able to infer their assigned phase over time based on the nature of the recommendations received. Study investigators and the data analysis team are not blinded to phase assignment.

Intervention model description

N-of-1 randomized crossover design in which each participant serves as their own control, randomized 1:1 to one of two intervention sequences (ABAB or BABA), alternating between RL-generated personalized exercise recommendations (active arm) and standard generic recommendations (control arm) across multiple 2-week blocks within the 9-week study period. First week is treated as a baseline week where participants get accommodated to the study App and procedures, as well as RL agent warm-up.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Exercise Recommendation Adherence RateAt 9 weeks at study completionExercise 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.
Participant Retention RateAt 9 weeks at study completionParticipant 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.

Secondary

MeasureTime frameDescription
Reinforcement Learning Agent Action Entropy Over TimeAt 9 weeks at study completionEntropy 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.

Countries

United States

Contacts

CONTACTIpek Ensari, PhD
ipek.ensari@mssm.edu631-565-1829
CONTACTGerard M Ona, MD
GerardAnneAprilOna@mssm.edu347-835-8115
PRINCIPAL_INVESTIGATORIpek Ensari, PhD

Icahn School of Medicine at Mount Sinai

PRINCIPAL_INVESTIGATORStefan Konigorski, PhD

Department of Computational Precision Nutrition, German Institute of Human Nutrition

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026