Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Percentage of Days Goal Met
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control
Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals
Incentive
An incentive will be used for this arm to encourage participants to meet their step goals
Intervention: Incentive (Other)
Outcomes
Primary Outcomes
Percentage of Days Goal Met
Time Frame: 12 Weeks
The primary outcome will be percent of days meeting goal during the intervention period
Secondary Outcomes
- RAPID3(26 Weeks)
- Psoriasis(26 Weeks)
- Patient Feedback(14 Weeks and 26 Weeks)
- Sleep Disturbance and Fatigue(26 Weeks)
- Completion of Activities by Study Participants (Feasibility)(26 Weeks)