Stepping Up For Inflammatory Arthritis

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic
• Interventions: Other: Incentive

• Registration Number: NCT02912221
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-23
• Study Start: 2017-04-24
• Primary Completion: 2019-10-24
• Study Completion: 2019-11-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incentive	Incentive	An incentive will be used for this arm to encourage participants to meet their step goals

Primary Outcome Measures

Name	Time	Method
Percentage of Days Goal Met	12 Weeks	The primary outcome will be percent of days meeting goal during the intervention period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States