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

Обзор

"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."

Подробное описание

"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."

Вмешательства

• Другое yoga program
  12-session weekly yoga program integrated into routine clinical care

Первичные конечные точки

• To evaluate the change in disease activity, assessed using validated disease-specific clinical activity indices routinely used in clinical practice (e.g., SELENA-SLEDAI for systemic lupus erythematosus). [Срок оценки: 6 month]

Вторичные конечные точки (7)

• To describe changes in fatigue over the course of follow-up [Срок оценки: 6 month]
• To describe changes in pain during follow-up [Срок оценки: 6 month]
• To describe changes in depressive symptoms during follow-up [Срок оценки: 6 month]
• To describe changes in health-related quality of life during follow-up [Срок оценки: 6 month]
• To describe changes in adherence to hydroxychloroquine treatment during follow-up [Срок оценки: 6 month]
• Number of disease flares during the follow-up period [Срок оценки: 6 month]
• Number of disease-related emergency department visits during the follow-up period [Срок оценки: 6 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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."

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• Hôpital Bichat - Claude-Bernard — Paris

Идентификаторы

NCT: NCT07685288 · APHP260560 · 2026-A00913-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗