Remote Exercise Program for Rheumatoid Arthritis

(TRAINERa Trial)

Overseen By Alyssa Sudnick, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Statins, Metformin, SGLT2 inhibitors, GLP1RA

Must not be taking: Exogenous insulin

Disqualifiers: Pregnancy, Malignancy, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of all RA and cardiovascular risk-related medications for at least one month, except for glucocorticoids. This means you should not change your current medications unless they are glucocorticoids.

What data supports the effectiveness of the treatment TRAINERa intensive exercise training for rheumatoid arthritis?

Research shows that home-based exercise programs for rheumatoid arthritis can improve muscle strength, physical function, and mood, and help maintain bone health over time. These findings suggest that similar remote exercise programs, like TRAINERa, could be effective in managing rheumatoid arthritis symptoms. ^{1 2 3 4 5}

Is the Remote Exercise Program for Rheumatoid Arthritis safe for humans?

Research on exercise programs for rheumatoid arthritis shows that while many studies report benefits, the reporting of harms is often inadequate. Pain is the most commonly reported harm, but overall, exercise is generally considered safe with proper supervision and guidelines. ^{4 6 7 8 9}

How is the TRAINERa intensive exercise training treatment different from other treatments for rheumatoid arthritis?

The TRAINERa intensive exercise training is unique because it focuses on a remote exercise program specifically designed for rheumatoid arthritis, which may include a combination of strength and aerobic exercises. This approach is different from traditional treatments that often emphasize medication and rest, as it aims to improve physical function and potentially reduce disease activity through regular, structured physical activity. ^{2 10 11 12 13}

Research Team

Brian J Andonian, MD, MHSc

Principal Investigator

Duke University

Eligibility Criteria

This trial is for individuals with Rheumatoid Arthritis who can participate in an intensive exercise program delivered remotely. Specific eligibility criteria are not provided, but typically participants would need to be stable enough to engage in physical activity and have internet access for remote participation.

Inclusion Criteria

History of fulfilling 2010 ACR/EULAR Classification Criteria for RA

I was diagnosed with RA less than 6 months ago and haven't started biologic DMARD therapy.

I have positive tests or signs of rheumatoid arthritis on X-rays.

Exclusion Criteria

Pregnant or intending to become pregnant during the intervention period

Lack of internet access

I do not have conditions like Paget's disease or hemochromatosis affecting my joints or muscles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TRAINERa intensive exercise training

Trial Overview The study is testing a new intensive exercise training program called TRAINERa, which combines aerobic and resistance exercises. It's designed specifically for people with Rheumatoid Arthritis and is delivered through remote means to assess its feasibility.

Participant Groups

Group I: TRAINERa intensive exercise training Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Out of 40 randomized controlled trials (RCTs) for rheumatoid arthritis (RA) and 25 for axial spondyloarthritis (axSpA), only 73% and 52% respectively reported information on harms, indicating a significant gap in the quality of reporting regarding adverse effects of supervised exercises.

Pain was the most commonly reported harm in both prespecified and non-prespecified outcomes, highlighting the need for better adherence to reporting guidelines like the CONSORT Harms 2022 Checklist to ensure a clearer understanding of the risks associated with exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. Teuwen, MMH., Vlieland, TPMV., van Weely, SFE., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Home exercise in rheumatoid arthritis functional class II: goal setting versus pain attention. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A home-based two-year strength training period in early rheumatoid arthritis led to good long-term compliance: a five-year followup. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Using internet technology to deliver a home-based physical activity intervention for patients with rheumatoid arthritis: A randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Recommendations and the state of the evidence for physical activity interventions for adults with rheumatoid arthritis: 2007 to present. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Sustained maintenance of exercise induced muscle strength gains and normal bone mineral density in patients with early rheumatoid arthritis: a 5 year follow up. [2018]

6. Sweden pubmed.ncbi.nlm.nih.gov

Supervised aerobic exercise is more effective than home aerobic exercise in female chinese patients with rheumatoid arthritis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Participant evaluation of a behavioral intervention targeting reduction of sedentary behavior in patients with rheumatoid arthritis: a mixed methods study. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Exercise intervention on cardiorespiratory fitness in rheumatoid arthritis patients with high cardiovascular disease risk: a single-arm pilot study. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Physical training of patients with rheumatoid arthritis]. [2006]

11. England pubmed.ncbi.nlm.nih.gov

Physical training in rheumatoid arthritis: A controlled long-term study. II. Functional capacity and general attitudes. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Education, self-management, and upper extremity exercise training in people with rheumatoid arthritis: a randomized controlled trial. [2014]

13. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an overall progressive resistance strength program for improving the functional capacity of patients with rheumatoid arthritis: a randomized controlled trial. [2019]