Stepping Up For Inflammatory Arthritis

Arthritis, Rheumatoid Clinical Trial

— SUFIA  

Official title:

Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912221
• Other study ID #: 825214
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: November 24, 2019

Study information

• Verified date: December 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid

Intervention

Other:
• Incentive
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.

Locations

Country	Name	City	State
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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