Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and prior to starting biologic DMARD therapy. Participants may be on one or a combination of the following conventional synthetic DMARDs: hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, azathioprine

• Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs

• History of fulfilling 2010 ACR/EULAR Classification Criteria for RA

• Active RA, not in clinical disease remission (Clinical Disease Activity Index for RA (CDAI) \> 2.8)

• Stable doses (for ≥ 1 month) of all RA and cardiovascular risk-related medications (including statins, metformin, SGLT2 inhibitors, GLP1RA) except for glucocorticoids

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Johanna Johnson, MS
johanna.johnson@duke.edu
19196606766
Backup
Brian J Andonian, MD, MHSc
brian.andonian@duke.edu
19196606743
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2026-09
Participants
Target number of participants: 15
Treatments
Experimental: TRAINERa intensive exercise training
Participants with early and active rheumatoid arthritis (RA) will complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program.
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov

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