NCT06653049

Brief Summary

The PERFORM-RL study (Personalised Exercise Prescription for Remote Fitness Using Reinforcement Learning) was a 12-week randomised crossover trial designed to evaluate the effectiveness of an app-based exercise prescription system powered by reinforcement learning (RL). The study aimed to investigate whether exercise sessions tailored by RL would lead to greater user satisfaction and higher exercise intensity compared to generic, non-personalised exercise sessions. The trial enrolled 62 participants (27 males, 42 females; mean age 42 years) who were randomly assigned to alternate between two conditions: an RL-driven intervention, which personalised exercise sessions based on user preferences and feedback, and a control condition with non-tailored, generic exercise sessions. Participants were instructed to complete three exercise sessions per week using the i80 BPM app, which offered a variety of video-guided exercises. The RL model customised these sessions based on user feedback, including satisfaction and perceived intensity, with the goal of optimising future sessions. The primary outcome was user satisfaction, measured via the Physical Activity Enjoyment Scale (PACES-8) after each session. Secondary outcomes included exercise intensity, as assessed by the Borg Rating of Perceived Exertion (RPE) scale, and heart rate data collected through a Samsung Galaxy Fit 2 smartwatch. The trial was conducted in Dublin, Ireland, and approved by the UCD Human Research Ethics Committee (LS-21-34-Tragos-Lawlor). Participants provided informed consent and were blinded to their group allocation. The trial was not registered prospectively, but steps are being taken for retrospective registration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 15, 2024

Last Update Submit

October 20, 2024

Conditions

Keywords

Reinforcement LearningmHealthExercise therapy

Outcome Measures

Primary Outcomes (1)

  • User Satisfaction with Exercise Sessions (PACES-8 Scale)

    User satisfaction was measured using the Physical Activity Enjoyment Scale (PACES-8), an abbreviated 8-item version. Participants rated their satisfaction with each exercise session on a scale from 1 (low satisfaction) to 5 (high satisfaction). Higher scores indicate greater enjoyment and overall satisfaction with the exercise experience. The measure was administered after each session.

    At the end of each exercise session during the 12-week study.

Secondary Outcomes (1)

  • Exercise Intensity (Borg Rating of Perceived Exertion Scale)

    At the end of each exercise session during the 12-week study.

Study Arms (2)

Reinforcement Learning (RL) Personalised Exercise Prescription

EXPERIMENTAL

Participants in this arm received personalised exercise sessions via the i80 BPM app, which utilised a reinforcement learning (RL) model. The RL algorithm adapted exercise parameters (e.g., intensity, type of exercise, duration) based on individual preferences, performance, and feedback to optimise user satisfaction and engagement. Sessions were tailored specifically to each participant over the 12-week trial period.

Device: Reinforcement Learning (RL) Personalised Exercise Prescription via i80 BPM App

Generic Non-Personalised Exercise Prescription

ACTIVE COMPARATOR

Participants in this arm received generic, non-personalised exercise sessions using the same i80 BPM app. These sessions did not adapt to user preferences or feedback and consisted of pre-designed exercises that were uniform across all participants. This arm served as a control to compare against the RL-personalised intervention.

Device: Generic Non-Personalised Exercise Prescription via i80 BPM App

Interventions

This intervention involved the use of a smartphone app, i80 BPM, which delivered personalised exercise prescriptions using a reinforcement learning (RL) model. The RL algorithm tailored the exercise sessions by adapting variables such as intensity, duration, and exercise type based on individual user preferences, real-time feedback, and performance data. This dynamic personalisation was designed to enhance user satisfaction and engagement over the 12-week study period. Participants completed three exercise sessions per week.

Reinforcement Learning (RL) Personalised Exercise Prescription

This intervention used the same i80 BPM smartphone app to deliver generic, pre-designed exercise sessions that did not adapt based on user preferences or feedback. The exercise sessions were standardised for all participants, with no customisation. The control arm served as a comparator to evaluate the impact of personalised, RL-driven exercise prescriptions. Participants completed three exercise sessions per week.

Generic Non-Personalised Exercise Prescription

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, recreationally active adults aged 18 to 65 years. Able to engage in aerobic activity for a total of 80 minutes at moderate intensity, no more than two times per week.
  • Able to provide informed consent. Ability to read and understand English to engage with the study materials and complete the app-based exercises.
  • Access to a compatible smartphone to download and use the i80 BPM app.

You may not qualify if:

  • Individuals with any physical disability or motor impairment that prevents participation in exercise.
  • Individuals with severe cognitive impairment. Individuals unable to read or write in English. Known contraindications to exercise, as identified by the 'Exercise Preparticipation Health Screening Questionnaire for Exercise Professionals'.
  • Participation in another clinical trial or study that could interfere with the trial results.
  • Engaging in high-level or professional athletic training or more than three days of vigorous physical activity per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Co. Dublin, D04C7X2, Ireland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this trial, participants were blinded to their condition (whether they were in the RL intervention or control group) throughout the study. The outcomes assessor, who analysed the data, was also blinded to the participants' condition to reduce potential bias in interpreting the results. Neither the care providers nor the investigators were masked, as they were responsible for managing the intervention and monitoring the trial's progress, ensuring the smooth operation of the app and data collection. No other parties were masked in this trial.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 22, 2024

Study Start

September 1, 2022

Primary Completion

November 16, 2022

Study Completion

November 30, 2022

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared, as the data are considered valuable intellectual property by the industry partners involved in the study. Sharing the data would conflict with existing agreements regarding the protection and use of proprietary information.

Locations