Physical Activity Through Health Technology in Axial Spondyloarthritis
2026年6月9日 更新者：Rachael Stovall、University of Washington
Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach
The purpose of this study is to find out whether a mobile app called the ExerciseRx app is a practical and helpful way for people with axial spondyloarthritis (axSpA) to receive exercise recommendations as part of their regular rheumatology care.
Researchers want to learn:
Whether people with axSpA find the ExerciseRx app easy to use and helpful for supporting regular exercise.
Whether using the ExerciseRx app leads to improvements in symptoms, physical function, and disease activity compared with usual care.
Participants assigned to the ExerciseRx group will use the app to complete guided exercises for 20-30 minutes, four times per week. They will also receive personalized weekly step-count goals to help increase their physical activity. Researchers will compare outcomes between participants using the app and those receiving usual care.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Joy Chan
- 电话号码：206-744-3626
- 邮箱：joychan@uw.edu
学习地点
-
-
Washington
-
Seattle、Washington、美国、98195
- 招聘中
- University of Washington
-
接触：
- Joy Chan
- 电话号码：206-744-3626
- 邮箱：exerciserx@uw.edu
-
Seattle、Washington、美国、98104
- 招聘中
- Harborview Medical Center
-
接触：
- Joy Chan
- 电话号码：206-744-3626
- 邮箱：exerciserx@uw.edu
-
首席研究员：
- Rachael Stovall, MD, MAS
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Diagnosis of axial spondyloarthritis by a rheumatologist
- English speaking
- Insufficiently active (less than 150 minutes of moderate intensity aerobic activity per week)
- Willing to wear a Fitbit for the study duration
- Willing to have or create a Google account and download the Google Health app (previously known as the Fitbit app)
Exclusion Criteria:
- Currently pregnant
- International travel or any circumstance causing lack of access to wi-fi/Internet at any point during the study period
- Recent or planned surgery that may affect ability to engage in physical activity
- Unable to exercise for health reasons, or a provider has recommended against exercising for safety/health reasons
- Unable to walk safely without difficulty, or is a fall risk (i.e., 3+ falls in past 6 months)
- History of a fall resulting in a fracture or head injury in the past 6 months
- Cardiovascular contraindicators for physical activity, or history of cardiovascular problems that may be exacerbated by physical activity, as defined by their rheumatologist
- Diabetes causing hypoglycemia following physical activity
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ExerciseRx app
the ExerciseRx app with personalized exercise recommendations, an educational handout, Fitbit-guided step goals, and physical therapy referral
|
Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive daily step count goals.
Patients also receive a FitBit to wear continuously throughout the study, and are given access to view their step counts via the ExerciseRx app, and receive an educational handout with exercises for axial spondyloarthritis.
|
|
有源比较器：Usual care
An educational handout, Fitbit monitoring without step goals, and physical therapy referral
|
Patients receive recommendations from their physicians to continue their usual physical activity as tolerated, receive a FitBit to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen, and receive an educational handout with exercises for axial spondyloarthritis.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Average minutes of physical activity/exercise during the week and % of participants with adherence to 60% or higher of the recommended exercises
大体时间：Week 0 (baseline), 6 and 12
|
We will measure feasibility by adherence to the recommended exercises in the intervention arm, including any additional reported physical activity throughout each week.
In the usual care arm, participants will report any physical therapy exercises completed from the handout, as well as other physical activity/exercise.
Adherence will be measured using the modified Short QUestionnaire to ASsess Health-enhancing physical activity (mSQUASH), a validated tool for capturing physical activity in axSpA.
For those in the intervention arm, adherence will also be captured via the built-in tracking features of the ExerciseRx app, providing an additional measure of feasibility.
Adherence or engagement with the ExerciseRx app will be measured in three domains: frequency of app use, adherence to recommended exercises, and interaction with behavioral features.
|
Week 0 (baseline), 6 and 12
|
|
Acceptability of the ExeriseRx app as a platform to complete recommended exercises for axial spondyloarthritis including % of participants with average score above 5 on MAUQ indicating usability
大体时间：Weeks 6 and 12
|
We will measure acceptability using the mHealth App Usability Questionnaire (MAUQ).
Scores range from 1 to 7 with scores above 5 on a 7-point Likert scale considered to show usability.
|
Weeks 6 and 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in disease activity over 12 weeks
大体时间：Weeks 0 (baseline), 6, and 12
|
We will measure changes in disease activity over the course of the study with Bath Axial Spondyloarthritis Disease Activity Index (BASDAI), a validated measure in axSpA.
BASDAI ranges from 0-10 with 0 indicating remission and 10 indicated very high disease activity.
|
Weeks 0 (baseline), 6, and 12
|
|
Change in functional status
大体时间：Weeks 0 (baseline), 6, and 12
|
We will measure changes in functional status over the course of the study via the Bath Axial Spondyloarthritis Functional Index (BASFI), a validated measure in axSpA.
BASFI ranges from 0-10 with 0 indicating full function and 10 indicating severe functional impairment.
|
Weeks 0 (baseline), 6, and 12
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Barriers and facilitators to physical activity/exercise
大体时间：Weekly throughout the 12 week study
|
Participants will receive weekly surveys from the ExerciseRx app regarding any barriers and facilitator to physical activity/exercise during the week.
|
Weekly throughout the 12 week study
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rachael Stovall, MD、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.