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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
"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."
详细描述
"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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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."
研究组 & 干预措施
YOGA group
Participants in the yoga group will participate in a 12-session weekly yoga program integrated into routine clinical care while continuing their usual medical management for systemic autoimmune and inflammatory diseases
干预措施: yoga program (Other)
control group
The control group will include patients with a systemic autoimmune or inflammatory disease receiving routine care who do not participate in the weekly yoga program and do not receive any structured therapeutic education or psychological support intervention during the study period
结局指标
主要结局
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).
时间窗: 6 month
次要结局
- To describe changes in fatigue over the course of follow-up(6 month)
- To describe changes in pain during follow-up(6 month)
- To describe changes in depressive symptoms during follow-up(6 month)
- To describe changes in health-related quality of life during follow-up(6 month)
- To describe changes in adherence to hydroxychloroquine treatment during follow-up(6 month)
- Number of disease flares during the follow-up period(6 month)
- Number of disease-related emergency department visits during the follow-up period(6 month)