Clinical trial NCT02912221: Stepping Up For Inflammatory Arthritis
Official title: Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Psoriatic
Arthritis, Rheumatoid
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Days Goal Met
timeFrame: 12 Weeks
Secondary outcomes:
measure: RAPID3
timeFrame: 26 Weeks
measure: Psoriasis
timeFrame: 26 Weeks
measure: Patient Feedback
timeFrame: 14 Weeks and 26 Weeks
measure: Sleep Disturbance and Fatigue
timeFrame: 26 Weeks
measure: Completion of Activities by Study Participants (Feasibility)
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: