15 Participants Needed

Yoga-Based Coaching for Lupus

(MiPAL Trial)

VK
RB
Overseen ByRachel Bergmans, MPH, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
Must be taking: Lupus medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special yoga coaching program can reduce pain for people with lupus, a condition where the immune system attacks its own tissues, causing inflammation and pain. The study involves participants following the MiPAL program, which includes yoga sessions tailored to their needs. Individuals diagnosed with lupus, experiencing constant pain for at least three months, and stable on their medications are suitable candidates for this trial. Participants must be able to join virtual sessions and have the necessary technology to participate from home.

As an unphased study, this trial offers a unique opportunity to explore innovative pain management strategies tailored to participants' needs.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on stable doses of your lupus-related medications, including prednisone, for at least 3 months before joining. It doesn't specify stopping any current medications, so you likely won't have to stop taking them.

What prior data suggests that this yoga-based coaching program is safe for people with lupus?

This trial studies a yoga-based coaching program for people with lupus. Yoga, which involves physical exercise and relaxation, generally poses minimal risk to participants. Available research has not identified specific safety concerns or negative effects linked to yoga.

The trial is marked as "Not Applicable" for its phase, indicating it does not test a new drug or device. Instead, it examines how well yoga can help manage lupus symptoms. This suggests that any safety risks are likely very low, as yoga is widely practiced and well-tolerated by many.

In summary, research data has not raised safety concerns about using yoga for lupus. This approach is typically safe, with the main focus on its potential benefits for reducing pain-related symptoms.12345

Why are researchers excited about this trial?

Unlike traditional lupus treatments, which often involve medications like corticosteroids or immunosuppressants, the yoga-based coaching approach focuses on lifestyle modification and mind-body techniques. Researchers are excited about this treatment because it emphasizes holistic wellness and stress reduction, potentially reducing flare-ups and improving overall quality of life. By integrating mindfulness and physical activity, this method may offer a complementary pathway to manage lupus symptoms without the side effects commonly associated with medication.

What evidence suggests that this yoga-based coaching is effective for reducing pain in lupus?

Research has shown that yoga can reduce pain and improve the quality of life for individuals with long-term health issues. Although specific research on yoga for systemic lupus erythematosus (SLE) is limited, yoga is known to lower stress, which often triggers lupus flare-ups. By reducing stress, yoga might decrease pain and fatigue in people with lupus. Additionally, yoga can enhance flexibility and muscle strength, potentially helping to manage symptoms. While more research is needed specifically on lupus, these benefits suggest yoga could be a useful tool for those with the condition.46789

Who Is on the Research Team?

RB

Rachel Bergmans, MPH, PhD

Principal Investigator

University of Michigan

DK

Dominique Kinnett-Hopkins, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with systemic lupus erythematosus (SLE) who have chronic pain. Participants must have internet access, stable lupus medication doses for the past 3 months, and be willing to attend virtual yoga coaching sessions. Pregnant individuals or those in other trials, taking high steroid doses, or unable to commit fully are excluded.

Inclusion Criteria

Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions
Access to necessary resources for participating in a remote intervention, including a smartphone, computer, or tablet with internet
I have had pain for 3 months or more and scored 8 or higher on a pain survey.
See 4 more

Exclusion Criteria

Pregnancy
Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials
I am taking more than 10 mg of prednisone or a similar steroid daily.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a tailored yoga coaching program to reduce pain-related symptoms

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MiPAL
Trial Overview The study is testing a personalized yoga-based coaching program called MiPAL designed to reduce pain in people with SLE. It involves attending recorded virtual sessions and practicing yoga as outlined by the program.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MiPAL participantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Rheumatology Research Foundation

Collaborator

Trials
14
Recruited
8,200+

Citations

Outcomes of patients with systemic lupus erythematosus ...A total of 3086 patients received belimumab (n=1869) or placebo (n=1217). BICLA response frequencies at week 52 were greater with belimumab vs ...
Mycophenolate Mofetil and New-Onset Systemic Lupus ...This randomized clinical trial of 130 participants found that MMF in addition to oral prednisone and hydroxychloroquine sulfate decreased severe flares.
Real-world effectiveness of belimumab and anifrolumab in ...Clinical trials have demonstrated that adding belimumab to standard lupus therapy is effective in active lupus patients aged ≥18 years across diverse ethnical ...
a comparative cohort study from the Medical Expenditure ...Although this study involved patient-reported data from the Medical Expenditure Panel Survey, these data are publicly available and ...
Towards a novel clinical outcome assessment for systemic ...Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40701623/
Safety of mycophenolate mofetil in systemic lupus ...Conclusions: MMF does not significantly increase the risk of severe infections compared with other immunosuppressants in SLE maintenance therapy ...
Patient-Reported Outcomes in Systemic Lupus ...In the French SLE sample, MCIDs ranged from 1.1 to 9.2 for respondents with global improvement in health status and from −0.5 to −6.4 for respondents with ...
Modelling long-term outcomes for patients with systemic ...This study sought to develop natural history models to identify predictors of long-term outcomes with current SoC SLE treatment.
Prediction of mortality risk in critically ill patients with ...The machine learning model provides a superior tool for predicting mortality risk in patients with SLE, offering a basis for clinical decision-making.
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