Arthritis, Rheumatoid Clinical Trial
— SUFIAOfficial title:
Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
NCT number | NCT02912221 |
Other study ID # | 825214 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 24, 2017 |
Est. completion date | November 24, 2019 |
Verified date | December 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.
Status | Completed |
Enrollment | 71 |
Est. completion date | November 24, 2019 |
Est. primary completion date | October 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - A diagnosis of RA or PsA by a rheumatologist - Followed by a Penn rheumatologist - Age 18-80 - A RAPID3 score of 3 - An active email account - Owns a smart phone and able to download an application - Willing to take internet based surveys weekly and allow data from a smart phone application to be uploaded Exclusion Criteria: - Inability to walk or regular use of a wheel chair or assistive device (e.g., walker or cane) - Hospitalization within the past 30 days - Heart or lung disease that precludes participation in an exercise study |
Country | Name | City | State |
---|---|---|---|
United States | Hospital at the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Days Goal Met | The primary outcome will be percent of days meeting goal during the intervention period | 12 Weeks | |
Secondary | RAPID3 | Comparison of RAPID3 score and amount of physical activity | 26 Weeks | |
Secondary | Psoriasis | Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis. | 26 Weeks | |
Secondary | Patient Feedback | Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26 | 14 Weeks and 26 Weeks | |
Secondary | Sleep Disturbance and Fatigue | Changes in sleep disturbance and fatigue as determined by PROMIS forms. | 26 Weeks | |
Secondary | Completion of Activities by Study Participants (Feasibility) | Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic | 26 Weeks |
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