Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT02912221
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 Weeks
The primary outcome will be percent of days meeting goal during the intervention period
Time frame: 26 Weeks
Comparison of RAPID3 score and amount of physical activity
Time frame: 26 Weeks
Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.
Time frame: 14 Weeks and 26 Weeks
Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26
Time frame: 26 Weeks
Changes in sleep disturbance and fatigue as determined by PROMIS forms.
Time frame: 26 Weeks
Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic
University of Pennsylvania
Other
Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
Acronym: SUFIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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