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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a remote exercise program to determine its effectiveness for individuals with early-stage Rheumatoid Arthritis (RA), a condition that causes joint pain and stiffness. The goal is to assess whether a 12-week program combining aerobic and resistance exercises, known as TRAINERa intensive exercise training, can be effectively performed at home. Participants must have been diagnosed with RA within the last six months, exhibit active symptoms, and not have started certain advanced medications. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance home-based RA management.

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 prior data suggests that this exercise program is safe for patients with Rheumatoid Arthritis?

Research has shown that aerobic exercise is generally safe and beneficial for people with rheumatoid arthritis (RA). It can enhance movement and alleviate RA symptoms. Studies also suggest that exercise helps maintain bone strength, particularly in the hips. Although limited data exists on long-term, high-intensity exercise for RA patients, existing research indicates that exercise is usually well-tolerated, with few serious side effects. This trial aims to determine the effectiveness of an intensive exercise program for RA without causing complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TRAINERa intensive exercise training for rheumatoid arthritis (RA) because it offers a unique approach compared to standard medications like NSAIDs, DMARDs, and biologics. Unlike traditional treatments, which focus on reducing inflammation through drugs, TRAINERa combines moderate to vigorous aerobic exercise with resistance training, tailored specifically for RA patients, and is delivered remotely. This allows participants to benefit from a personalized fitness program that could improve joint function and overall health without the side effects often associated with medication. The remote supervision aspect also makes it more accessible and convenient for individuals who may have difficulty attending in-person sessions.

What evidence suggests that this exercise program is effective for Rheumatoid Arthritis?

Research shows that exercise programs like TRAINERa, which participants in this trial will undergo, can help manage rheumatoid arthritis (RA) symptoms. Studies have found that moderate exercise improves muscle strength and overall function more effectively than intense exercise. However, intensive exercise programs boost muscle strength better than less demanding options for people with active RA. Specifically, patients who participated in intensive exercise for two years improved their ability to perform daily activities. These findings suggest that a structured exercise program could benefit those with RA. ^{3 4 6 7 8}

Who Is on the Research Team?

Brian J Andonian, MD, MHSc

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06841562?cond=Arthritis&aggFilters=status:rec&country=United%20States&locStr=United%20States&viewType=Table&rank=8

Targeted Remotely-delivered Anti-inflammatory ... New clinical data will be collected from 15 participants with rheumatoid arthritis before and after a 12-week exercise training intervention. All de ...

2. withpower.com withpower.com/trial/remote-exercise-program-for-rheumatoid-arthritis-ae98f

Remote Exercise Program for Rheumatoid Arthritis These findings suggest that similar remote exercise programs, like TRAINERa, could be effective in managing rheumatoid arthritis symptoms. Show more ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12495934/

Effect of Exercise Interventions for Rheumatoid Arthritis Basic experimental studies have demonstrated that moderate-intensity exercise interventions yield superior outcomes compared to high-intensity ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724425326

Effect of intensive exercise on patients with active ... CONCLUSION. A short term intensive exercise programme in active RA is more effective in improving muscle strength than a conservative exercise programme and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00434200

NCT00434200 | Rheumatoid Arthritis Patients in Training The patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06841562

Study Details | NCT06841562 | Targeted Remotely ... New clinical data will be collected from 15 participants with rheumatoid arthritis before and after a 12-week exercise training intervention. All de ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/13130460/

Is a long-term high-intensity exercise program effective and ... Objective: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA).

8. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-022-00408-2

Effectiveness and safety of aerobic exercise for rheumatoid ... Generally, aerobic exercise is beneficial and safe for RA patients and has a certain alleviating effect on the disease, such as functional ability improvement, ...