NCT06270641 · University of Washington
Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
What this study is about
This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the effectiveness of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).
View original scientific description
This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).
Interventions
OTHER
ExerciseRx intervention
ExerciseRx is a cloud-based, HIPPA-compliant free software platform created for healthcare providers to prescribe and monitor physical activity as part of routine care. ExerciseRx translates clinically relevant activity data collected by the patient's existing personal smart devices (Android or iOS phone) into actionable metrics on a dashboard within the Epic electronic health record. Providers then use the platform to prescribe physical activity tailored to patients' ability levels and preferences. The platform incorporates behavior change strategies, including motivational feedback and nudges. It also facilitates a feedback loop with the provider, fostering caring patient-provider connections around activity promotion and behavior change. ExerciseRx leverages patients' personal smartphone capabilities to track, quantify, and tailor personalized physical activity solutions, which makes it more readily scalable as a solution across diverse patient populations.
Primary outcome measures
Physical activity: daily average step count
Time frame: Baseline and week 13
Increase in physical activity measured by daily average step count measured by ExerciseRx app. Increase in physical activity will be measured and compared between the ExerciseRx and usual care participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provider-confirmed diagnosis of MS using revised 2017 McDonald criteria
- \> 18+ years of age
- Patient determined disease steps (PDDS) score \< 3, indicating the potential for some gait disability although typically ambulates without an assistive device
- Insufficiently active, defined as \< 150 minutes of physical activity per week, assessed using the PAVS in the EHR in clinics as part of the routine patient intake process
- Use of an iPhone with software version iOS13+ or an Android phone 4.1+
- Agree to install and use the ExerciseRx app for the entire study period and keep their phone on them during the daytime (e.g., pocket, bags, hands)
Exclusion criteria
- Recent (past 4 weeks) or planned surgery during the study period which may impact engaging in step counts
- MS relapse within the last 30 days
- Plans to travel internationally during the study period, which could interfere with server uploads of mobile phone data
- Those at a higher risk of falling or injury from falls or unable to safely exercise due to other medical conditions (e.g. heart conditions, diabetes or conditions made worse by walking or physical activity)
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 22, 2024 · Source of record for eligibility and locations