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

Trial Summary

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 data supports the effectiveness of the treatment DREAM Adaptive Intervention for arthritis?

Research shows that exercise programs, like the DREAM Adaptive Intervention, can help people with arthritis by improving their physical activity, muscle strength, and overall quality of life. Studies on similar treatments have found that regular physical activity and self-management education can lead to better health outcomes for those with arthritis. ^{1 2 3 4 5}

Is exercise generally safe for people with arthritis?

In studies on supervised exercise for people with rheumatoid arthritis or axial spondyloarthritis, pain was the most commonly reported harm, but many trials did not report harms adequately. It's important to consider both benefits and potential harms when deciding on exercise for arthritis. ^{6 7 8 9 10}

How is the DREAM Adaptive Intervention treatment for arthritis different from other treatments?

The DREAM Adaptive Intervention for arthritis is unique because it focuses on a self-directed exercise program, which is designed to be safe, evidence-based, and cost-effective, allowing for high reach among patients. This approach contrasts with traditional treatments that may rely more on medication or supervised therapy sessions. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

Research Team

Christine Pellegrini, PhD

Principal Investigator

University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical activity coaching of patients with rheumatoid arthritis in everyday practice: a long-term follow-up. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinically meaningful changes in functional performance resulting from self-directed interventions in individuals with arthritis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Team-based rehabilitation improves long-term aerobic capacity and health-related quality of life in patients with chronic inflammatory arthritis. [2022]

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

A home-based pedometer-driven walking program to increase physical activity in older adults with osteoarthritis of the knee: a preliminary study. [2022]

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

Home based exercise programme for knee pain and knee osteoarthritis: randomised controlled trial. [2022]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the self-directed format of Walk With Ease in patients with systemic lupus erythematosus: the Walk-SLE Pilot Study. [2019]

8. United States 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. [2020]

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

Achievement of exercise objectives and satisfaction with the walk with ease program-group and self-directed participants. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The steps to health randomized trial for arthritis: a self-directed exercise versus nutrition control program. [2022]

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

Examination of self-regulatory efficacy and pain among individuals challenged by arthritis flares. [2015]

14. England pubmed.ncbi.nlm.nih.gov

A 5-year follow-up of a controlled trial of an arthritis education programme. [2019]

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

A randomized controlled trial of the people with arthritis can exercise program: symptoms, function, physical activity, and psychosocial outcomes. [2008]