Exercise for Arthritis

(DREAM Trial)

Overseen By Ellen Wingard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Pregnancy, Uncontrolled hypertension, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying amounts of exercise can alleviate arthritis symptoms. Participants will exercise for 45, 90, or 150 minutes a week to determine which duration provides the most relief. It suits individuals diagnosed by a doctor with arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia who are not currently engaging in much exercise. As an unphased trial, this study offers a unique opportunity to enhance understanding of exercise benefits for arthritis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise protocol is safe for arthritis patients?

Research has shown that exercise is generally safe and beneficial for people with arthritis. Studies have found that physical activity can reduce pain and improve mobility, while also helping to prevent other health issues. A review of multiple studies found that exercise programs led to moderate improvements in activity levels and small reductions in pain for people with arthritis.

The DREAM Adaptive Intervention provides a personalized exercise plan designed for safety. It allows participants to adjust their activity levels based on their capabilities. Overall, regular exercise is well-tolerated and poses a low risk for most people with arthritis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Exercise for Arthritis" trial because it explores how different levels of physical activity might benefit people with arthritis. Unlike standard treatments, which often include medications like NSAIDs and DMARDs to manage pain and inflammation, this trial focuses on the potential of exercise as a direct intervention. The trial tests three specific exercise goals — 45, 90, and 150 minutes per week of moderate-to-vigorous activity — to determine which amount provides the best relief. This approach is unique because it examines exercise as a tailored prescription, potentially offering a natural, non-pharmaceutical way to manage arthritis symptoms.

What evidence suggests that this trial's treatments could be effective for arthritis?

Studies have shown that exercise programs can greatly benefit people with arthritis. Research indicates that regular physical activity reduces pain and improves mobility. In this trial, participants will follow different exercise goals within the DREAM Adaptive Intervention, which focuses on moderate-to-vigorous exercise. This type of exercise has been linked to healthier joints and reduced arthritis pain. Many participants in similar programs have experienced noticeable pain relief within one month of starting their exercise routine. This evidence suggests that regular exercise, as in the DREAM program, can effectively manage arthritis symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

Christine Pellegrini, PhD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with various forms of arthritis or related conditions, such as Fibromyalgia, Lupus, and Rheumatoid Arthritis. Participants should be able to perform physical activity and are looking to manage their symptoms through exercise.

Inclusion Criteria

Ability to read and write in English

I have been diagnosed with arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia.

Exclusion Criteria

Have a serious cognitive impairment

Are pregnant, breastfeeding, or planning to become pregnant in the next year

Are planning to relocate out of the Columbia, SC area in the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a physical activity program with goals of 45, 90, or 150 minutes per week for 6 months, supported by the Arthritis Foundation's Walk With Ease Guidebook, behavioral lessons, a Fitbit, and monthly coaching calls.

6 months

Follow-up

Participants are monitored for changes in physical function, quality of life, pain intensity, and depression symptoms.

6 months

Long-term Follow-up

Participants are further monitored for changes in physical function and pain intensity.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DREAM Adaptive Intervention

Trial Overview The study is testing the 'DREAM Adaptive Intervention' which involves participants engaging in one of three different levels of physical activity: light (45 minutes/week), moderate (90 minutes/week), or vigorous (150 minutes/week) to see how it affects arthritis management.

How Is the Trial Designed?

Group I: 90 minutes/week Experimental Treatment 1 Intervention

Participants will be given a goal of 90 minutes/week of moderate-to-vigorous intensity physical activity

Group II: 45 minutes/week Experimental Treatment 1 Intervention

Participants will be given a goal of 45 minutes/week of moderate-to-vigorous intensity physical activity

Group III: 150 minutes/week Experimental Treatment 1 Intervention

Participants will be given a goal of 150 minutes/week of moderate-to-vigorous intensity physical activity

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

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]

Both group and self-directed formats of the Arthritis Foundation's Walk With Ease program led to significant increases in walking duration, with participants averaging around 34 minutes of walking at the 1-year follow-up.

While both formats showed similar self-reported walking outcomes, group participants were more likely to engage in recommended stretching and warm-up/cool-down exercises, suggesting that group settings may enhance adherence to comprehensive exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achievement of exercise objectives and satisfaction with the walk with ease program-group and self-directed participants. Nyrop, KA., Cleveland, R., Callahan, LF.[2016]

A study involving 305 participants with musculoskeletal conditions found that a web-based exercise programming system significantly improved adherence to home exercise programs compared to traditional methods, with notable differences in overall adherence and specific exercise metrics.

Participants using the web-based system reported greater confidence in their ability to perform prescribed exercises, although both groups had similar satisfaction levels with the exercise delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Web-Based Exercise Programming System Improve Home Exercise Adherence for People With Musculoskeletal Conditions?: A Randomized Controlled Trial. Bennell, KL., Marshall, CJ., Dobson, F., et al.[2020]

A one-year coaching program aimed at increasing physical activity in 228 patients with early rheumatoid arthritis did not lead to significant long-term improvements in perceived general health or other health outcomes after two years.

While the intervention group showed different patterns of physical activity behavior compared to the control group, the lack of sustained behavioral elements may have contributed to the absence of lasting benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity coaching of patients with rheumatoid arthritis in everyday practice: a long-term follow-up. Sjöquist, ES., Brodin, N., Lampa, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00636454

https://clinicaltrials.gov/ct2/show/NCT00636454 No information is available for this page.

2. withpower.com withpower.com/trial/phase-fibromyalgia-fm-3-2025-e7ee6

Exercise for Arthritis (DREAM Trial) Research shows that exercise programs, like the DREAM Adaptive Intervention, can help people with arthritis by improving their physical activity, muscle ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085311/

Improving Clinical Management and Patient-Reported ... In MDA/HDA patients, pain decreased significantly from enrollment at month 1 (p < 0.0001), month 3 (p < 0.0001), and month 6 (p = 0.0094).

4. researchgate.net researchgate.net/publication/332736592_Cost-effectiveness_of_different_treat-to-target_strategies_in_rheumatoid_arthritis_results_from_the_DREAM_registry

(PDF) Cost-effectiveness of different treat-to-target ... Cost-effectiveness of different treat-to-target strategies in rheumatoid arthritis: results from the DREAM registry. April 2019; BMC Rheumatology 3(1). DOI ...

5. academic.oup.com academic.oup.com/rheumatology/article/64/3/1068/7643527

Deep learning enables automatic detection of joint damage ... Deep learning algorithms have demonstrated substantial potential in a variety of biomedical problems, including radiographic scoring in RA [6, 7] ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9870707/

Implementation of physical activity interventions for people ... A meta-analysis published in 2013 highlighted that across 21 studies of people with knee OA, only 13% of people met physical activity guidelines ...

7. jospt.org jospt.org/doi/10.2519/jospt.2018.7877

Physical Activity and Exercise Therapy Benefit More Than ... Physical activity and exercise therapy not only improve symptoms and impairments of OA, but are also effective in preventing at least 35 chronic conditions.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17888500/

Physical activity interventions among adults with arthritis Conclusions: Physical activity interventions resulted in moderate positive effects on physical activity behavior and small positive effects on pain and physical ...

9. researchgate.net researchgate.net/publication/5954723_Physical_Activity_Interventions_Among_Adults_with_Arthritis_Meta-Analysis_of_Outcomes

Physical Activity Interventions Among Adults with Arthritis This meta-analytic review integrates results from primary research studies testing interventions to increase physical activity in arthritis ...