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

NCT07685288 | Not Yet Recruiting

• 2 other identifiers: APHP2605602026-A00913-48
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Auto Immune Disease; Auto-inflammatory Disease

Keywords

YOGA; systemic autoimmune or inflammatory disease (SAID)

Outcome Measures

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).

  6 month

Secondary Outcomes (7)

• 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

Study Arms (2)

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

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

Other: yoga program

Interventions

yoga program OTHER

12-session weekly yoga program integrated into routine clinical care

YOGA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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."

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat - Claude-Bernard

Paris, 75018, France

Location

Study Officials

• Tiphaine Goulenok, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiphaine Goulenok, MD

CONTACT

0140257289; tiphaine.goulenok@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

FR (1)