Arthritis, Psoriatic, Arthritis, Rheumatoid
Conditions
Brief summary
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.
Detailed description
Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic, systemic inflammatory disorders affecting 1-2% of the US population. Ongoing chronic inflammation and lack of exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss, obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all of which impact physical functioning and quality of life. Increases in physical activity can significantly impact each one of these outcomes and are likely to positively impact a patients experience of their disease. This study will examine the benefits of a monitored physical activity program. This study will use a wearable activity device (e.g. fitbit) to monitor step counts and will incentivize one group to achieve higher step counts than the control group. The primary goal of this pilot study will be to determine whether one incentive (loss aversion) is better than no incentive in increasing step counts and maintaining an increased level of physical activity. Additional outcomes of interest are patient reported disease activity (using the RAPID3 patient reported outcome) and physician measured disease activity, quality of life assessments and weight loss.
Interventions
OTHERIncentive
Both groups will receive fitbits to track their physical activity, however one arm of the study may receive additional incentives to achieve their step count goal.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Goal Met | 12 Weeks | The primary outcome will be percent of days meeting goal during the intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAPID3 | 26 Weeks | Comparison of RAPID3 score and amount of physical activity |
| Psoriasis | 26 Weeks | Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis. |
| Patient Feedback | 14 Weeks and 26 Weeks | Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26 |
| Sleep Disturbance and Fatigue | 26 Weeks | Changes in sleep disturbance and fatigue as determined by PROMIS forms. |
| Completion of Activities by Study Participants (Feasibility) | 26 Weeks | Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic |
Countries
United States
Outcome results
None listed