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

Starting soon

Conditions studied: Auto Immune Disease, Auto-inflammatory Disease

In brief

"Systemic autoimmune and inflammatory diseases (SAIDs) are chronic disorders associated with substantial impairment in quality of life, largely due to persistent fatigue, chronic pain, and mood disorders. Fatigue affects more than two-thirds of patients with systemic autoimmune diseases, particularly those with systemic lupus erythematosus (SLE), and is one of the major determinants of health-related quality of life. Fatigue has also been associated with suboptimal treatment adherence. Mind-body interventions, including yoga, have demonstrated beneficial effects on fatigue, mood, and quality of life in several systemic autoimmune and inflammatory diseases. In patients with SLE, previous studies suggest that appropriately adapted physical activity is safe and may improve functional outcomes without increasing the risk of disease flares. Improving non-specific symptoms such as fatigue, pain, and mood disorders may also contribute to better treatment adherence, which is essential for long-term disease control. However, real-world data on the overall impact of yoga integrated into routine clinical care on disease activity and treatment adherence remain limited. This prospective observational study aims to evaluate the association between participation in a 12-session weekly yoga program delivered as part of standard care and changes in clinical outcomes among adults with systemic autoimmune and inflammatory diseases, predominantly systemic lupus erythematosus, followed in the Internal Medicine Department of Bichat-Claude Bernard Hospital. The study will assess changes in disease activity using disease-specific validated activity indices (including SELENA-SLEDAI for patients with SLE), fatigue, pain intensity, depressive symptoms, and health-related quality of life. Treatment adherence will be evaluated by whole-blood hydroxychloroquine concentrations obtained as part of routine clinical care. The frequency of disease flares and disease-related emergency department visits during follow-up will also be recorded. Participants will be enrolled over a 6-month period and followed for 6 months, which corresponds to routine clinical follow-up and allows assessment of clinically meaningful changes during and after the 3-month yoga program."

Key facts

Study ID

NCT07685288

Run by

Assistance Publique - Hôpitaux de Paris

People needed

100

Starts

2026-07-01

Expected to finish

2027-08-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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."

Where it is running

• Hôpital Bichat - Claude-Bernard — Paris, France

Full record on ClinicalTrials.gov

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