Effect of a Weekly Yoga Program Integrated Into Standard Care on Disease Activity, Fatigue, Mood, and Treatment Adherence in Patients With Systemic Autoimmune and Inflammatory Diseases: A Prospective Observational Study

"Background

Systemic autoimmune and inflammatory diseases (SAIDs) are chronic disorders associated with substantial impairment in health-related quality of life. Persistent fatigue, chronic pain, and mood disorders are among the most burdensome manifestations and remain insufficiently controlled despite advances in pharmacological treatment. Fatigue is particularly common in patients with systemic lupus erythematosus (SLE), affecting more than two-thirds of patients, and has been associated with reduced quality of life and poorer treatment adherence.

Mind-body interventions, including yoga, have demonstrated beneficial effects on fatigue, psychological well-being, and quality of life in several chronic inflammatory diseases. In patients with SLE, adapted physical activity has been shown to be safe and is not associated with an increased risk of disease flares. Improving non-specific symptoms such as fatigue, pain, and mood disorders may also enhance long-term adherence to treatment, an essential component of disease management.

Although yoga is increasingly offered as a complementary intervention in routine clinical practice, evidence regarding its overall impact on disease activity, patient-reported outcomes, and treatment adherence in real-world settings remains limited.

Study Rationale

The purpose of this prospective observational study is to evaluate the association between participation in a weekly yoga program integrated into routine care and clinical outcomes in adults with systemic autoimmune and inflammatory diseases, predominantly systemic lupus erythematosus. Because the yoga program is part of standard care, no study-specific intervention will be assigned.

Study Population

The study will include adults (≥18 years) with a diagnosis of a systemic autoimmune or inflammatory disease, predominantly systemic lupus erythematosus, who are followed in the Department of Internal Medicine at Bichat-Claude Bernard Hospital. Eligible participants will have stable disease or low disease activity and will voluntarily participate in the weekly yoga program offered as part of routine care.

Study Design

This is a single-center, prospective observational study conducted in a real-world clinical setting. Participants enrolled in the study will attend a standardized weekly yoga program consisting of 12 sessions over a 3-month period while continuing their usual medical management. Clinical and biological data routinely collected during standard follow-up visits will be recorded prospectively. Participants will be followed for 6 months, allowing assessment of changes occurring during and after completion of the yoga program.

The planned recruitment period is 6 months, which is expected to provide an adequate sample of eligible patients receiving routine care in the study center."

Inclusion criteria

• Adults aged 18 years or older.
• Diagnosis of a systemic autoimmune or inflammatory disease established according to the current internationally accepted classification criteria for the specific disease.
• Stable disease or low disease activity at the time of enrollment.
• Receiving regular follow-up in the Department of Internal Medicine at Bichat-Claude Bernard Hospital.

Exclusion criteria

• Severe disease flare requiring a major change in treatment at the time of enrollment.
• Medical contraindication to gentle physical activity.
• Refusal to participate in the study after receiving study information."