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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

"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."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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."

Trial population

The target population consists of adults with systemic autoimmune and inflammatory diseases (SAIDs), predominantly systemic lupus erythematosus (SLE), who receive routine follow-up in the Department of Internal Medicine at Bichat-Claude Bernard Hospital. This population is particularly affected by chronic fatigue and mood disorders, making it an appropriate population in which to evaluate the potential benefits of a mind-body intervention such as yoga.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • yoga program

    Other intervention

    12-session weekly yoga program integrated into routine clinical care

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: control group0 interventions
Group B: YOGA group1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 month

Secondary outcomes

1

To describe changes in fatigue over the course of follow-up

as assessed using PICOT fatigue scale.

Time frame
6 month
2

To describe changes in pain during follow-up

as assessed using a visual analogue scale (VAS)

Time frame
6 month
3

To describe changes in depressive symptoms during follow-up

as assessed using the Hospital Anxiety and Depression Scale (HADS)

Time frame
6 month
4

To describe changes in health-related quality of life during follow-up

as assessed using the 36-Item Short Form Health Survey (SF-36)

Time frame
6 month

Other outcomes

Sponsors and contacts

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