Stepping Up For Inflammatory Arthritis (SUFIA)

December 4, 2020 updated by: University of Pennsylvania

Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital at the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals
Active Comparator: Incentive
An incentive will be used for this arm to encourage participants to meet their step goals
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days Goal Met
Time Frame: 12 Weeks
The primary outcome will be percent of days meeting goal during the intervention period
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAPID3
Time Frame: 26 Weeks
Comparison of RAPID3 score and amount of physical activity
26 Weeks
Psoriasis
Time Frame: 26 Weeks
Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.
26 Weeks
Patient Feedback
Time Frame: 14 Weeks and 26 Weeks
Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26
14 Weeks and 26 Weeks
Sleep Disturbance and Fatigue
Time Frame: 26 Weeks
Changes in sleep disturbance and fatigue as determined by PROMIS forms.
26 Weeks
Completion of Activities by Study Participants (Feasibility)
Time Frame: 26 Weeks
Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

November 24, 2019

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 825214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share the results of the study after completion of the study through publication in a peer-reviewed journal. Investigators wishing to use the de-identified dataset for additional analyses can contact the PI after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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