Stepping Up For Inflammatory Arthritis

NCT02912221 | Completed

• 1 other identifier: 825214
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Psoriatic; Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Percentage of Days Goal Met

  The primary outcome will be percent of days meeting goal during the intervention period

  12 Weeks

Secondary Outcomes (5)

• RAPID3

  26 Weeks

• Psoriasis

  26 Weeks

• Patient Feedback

  14 Weeks and 26 Weeks

• Sleep Disturbance and Fatigue

  26 Weeks

• Completion of Activities by Study Participants (Feasibility)

  26 Weeks

Study Arms (2)

Control

NO INTERVENTION

Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals

Incentive

ACTIVE COMPARATOR

An incentive will be used for this arm to encourage participants to meet their step goals

Other: Incentive

Interventions

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.

Incentive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alexis Ogdie-Beatty, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: April 24, 2017
• Primary Completion: October 24, 2019
• Study Completion: November 24, 2019
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)