Increasing Physical Activity Via Provider Prescription and Engagement: Efficacy of ExerciseRx for Adults With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Physical activity: daily average step count
研究概览
简要总结
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).
详细描述
This study aims to test the efficacy of ExerciseRx, a free software platform designed to increase physical activity in people with multiple sclerosis (PwMS). Exercise is crucial for managing MS symptoms and overall health, but approximately 80% of PwMS do not get enough physical activity due to barriers like physical limitations, common MS symptoms, and lack of community exercise facilities. ExerciseRx translates clinically relevant activity data collected by personal smart devices into actionable metrics on a dashboard within the Epic electronic health record, allowing healthcare providers to prescribe and monitor tailored physical activity solutions for their patients. This study will test the effects of ExerciseRx in a sample of inactive PwMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Usual care
Participants receive MS Exercise and Physical Activity Recommendations, will continue typical physical activity, and complete validated self-report assessments.
At the end of 26 weeks, staff will offer the participants the ExerciseRx intervention protocol.
Intervention ExerciseRx-MS
Participants use the ExerciseRx app to meet personalized daily step targets and weekly goals. They will receive MS Exercise and Physical Activity Recommendations and complete in-app surveys about barriers to being active and physical activity level. The ExerciseRx app will adjust the personalized step count goals based on percentage met of the previous week goal and providers will send supportive messages based on participant activity. Participants will complete validated self-report assessments.
Providers may also provide participants with additional guidance, make referrals, or schedule telemedicine or in-person clinic follow ups if needed to support the participant's physical activity progression.
干预措施: ExerciseRx intervention (Other)
结局指标
主要结局
Physical activity: daily average step count
时间窗: 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.
次要结局
- Pain interference - PROMIS Pain Interference Scale Short Form 6a(Baseline, weeks 13 and 26)
- Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a(Baseline, weeks 13 and 26)
- Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a(Baseline, weeks 13 and 26)
- Pain intensity - PROMIS Pain Intensity Short Form 3a(Baseline, weeks 13 and 26)
- Depressive symptom severity - PROMIS Depression Short Form 8a(Baseline, weeks 13 and 26)
- Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a(Baseline, weeks 13 and 26)
- Activity volume(Baseline, weeks 13 and 26)
- Minutes/week of moderate intensity aerobic activity(Baseline, weeks 13 and 26)
- Fatigue - PROMIS Fatigue-MS Short Form 8a(Baseline, weeks 13 and 26)
- Physical functioning - PROMIS Physical Function 10a(Baseline, weeks 13 and 26)
研究者
Dawn Ehde
Principal Investigator
University of Washington