Auto Immune DiseaseYOGAMIDNCT07685288
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
An observational study of Auto Immune Disease and Auto-inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto Immune Disease, Auto-inflammatory Disease
- What is being tested?
- yoga program
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Bichat - Claude-Bernard
Paris, 75018
Tiphaine Goulenok, MD, 0140257289 ext. 33, tiphaine.goulenok@aphp.fr
About this study
"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.
Read more
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."
Read the detailed description
"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."
- Conditions
- Auto Immune Disease, Auto-inflammatory Disease
- Being tested
- yoga program
- Keywords
- YOGA, systemic autoimmune or inflammatory disease (SAID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga programOther
12-session weekly yoga program integrated into routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: yoga program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 month
Secondary outcomes (7)
To describe changes in fatigue over the course of follow-up
as assessed using PICOT fatigue scale.
Measured: 6 month
To describe changes in pain during follow-up
as assessed using a visual analogue scale (VAS)
Measured: 6 month
To describe changes in depressive symptoms during follow-up
as assessed using the Hospital Anxiety and Depression Scale (HADS)
Measured: 6 month
To describe changes in health-related quality of life during follow-up
as assessed using the 36-Item Short Form Health Survey (SF-36)
Measured: 6 month
To describe changes in adherence to hydroxychloroquine treatment during follow-up
as assessed by whole-blood hydroxychloroquine concentrations
Measured: 6 month
Number of disease flares during the follow-up period
Measured: 6 month
Number of disease-related emergency department visits during the follow-up period
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto Immune DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine Goulenok, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685288
- Sponsor's protocol ID
- APHP260560
- Other IDs
- 2026-A00913-48
- Acronym
- YOGAMID
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07685288
- Acronym / sponsor ID
- YOGAMID / APHP260560
- Conditions
- Auto Immune Disease, Auto-inflammatory Disease
- Keywords
- YOGA, systemic autoimmune or inflammatory disease (SAID)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Detailed description
"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."
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: yoga programParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yoga program12-session weekly yoga program integrated into routine clinical care | Other | YOGA group |
Primary outcome
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
7 secondary outcomes
To describe changes in fatigue over the course of follow-up
Time frame: 6 month
To describe changes in pain during follow-up
Time frame: 6 month
To describe changes in depressive symptoms during follow-up
Time frame: 6 month
To describe changes in health-related quality of life during follow-up
Time frame: 6 month
To describe changes in adherence to hydroxychloroquine treatment during follow-up
Time frame: 6 month
Number of disease flares during the follow-up period
Time frame: 6 month
Number of disease-related emergency department visits during the follow-up period
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiphaine Goulenok, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto Immune Disease and Auto-inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiphaine Goulenok, MD (0140257289 ext. 33, tiphaine.goulenok@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.