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OpenTrials
Completed

NCT Number: NCT02912221

Stepping Up For Inflammatory Arthritis

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentive

Other

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.

Primary outcomes

  1. 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

  1. RAPID3

    Time frame: 26 Weeks

    Comparison of RAPID3 score and amount of physical activity

  2. Psoriasis

    Time frame: 26 Weeks

    Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.

  3. Patient Feedback

    Time frame: 14 Weeks and 26 Weeks

    Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26

  4. Sleep Disturbance and Fatigue

    Time frame: 26 Weeks

    Changes in sleep disturbance and fatigue as determined by PROMIS forms.

  5. Completion of Activities by Study Participants (Feasibility)

    Time frame: 26 Weeks

    Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: SUFIA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2016
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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