Yoga for Patients With Rheumatoid Arthritis

University Hospital Dubrava

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Arthritis-education; Behavioral: Yoga program

Study type: Interventional

Funder types: Other

Identifiers

NCT03500276

DUBRAVA-YOGRA-01

Details and patient eligibility

About

The purpose of this study is to investigate the effects of a yoga program based on "Yoga in daily life system" in patients with rheumatoid arthritis.

The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.

Full description

Rheumatoid arthritis (RA) is a chronic disabling inflammatory disease that substantially impacts health-related quality of life (HRQOL) of patients. In addition to pain, fatigue and physical disability the disease also affects psychological health. Yoga, a mind-body therapy, integrates physical exercises with relaxation and meditation. Published data suggest its beneficial effects on both physical and mental health in various chronic conditions. The true biological mechanism underlying these effects is not well known. Recent research suggests potential modulation of the immune system and inflammation-related gene expression changes.

Hypothesis: Yoga program based on Yoga in daily life system has positive impact on clinical and biologic outcomes in RA patients.

Aims: To determine the impact of a 12-week yoga program on measures of psychological distress, HRQOL, fatigue, pain, disease activity, levels of circulating inflammatory markers and pro-inflammatory gene expression.

Materials and methods: 50 RA patients, aged 18-65 years, on stable standard pharmacological treatment will be randomly assigned to a 12-week yoga intervention (based on "Yoga in daily life system") or arthritis-education control. Self-administered questionnaires will be used to assess quality of life and psychological well-being of the patients. Blood samples will be collected for measurement of inflammatory markers and expression of a set of pro-inflammatory genes. Disease activity will be assessed by DAS28CRP score. The patients will be assessed on baseline, post-treatment and at 3 months follow-up.

This research will provide information on potential efficacy of yoga program in improving physical and psychological outcomes in persons with RA and explore its influence on immunological system.

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA)
2. disease activity measured by DAS28CRP< 5.1
3. patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months

Exclusion criteria

1. significant co-morbidity (active malignant disease, symptomatic ischemic heart disease or heart failure, severe lung disease, uncontrolled thyroid disease, neurological disease that impairs mobility) that is more limiting than RA
2. history of drug or alcohol abuse
3. recent injury/ or surgery
4. regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for >=2 times weekly, patients that are currently engaged in physical therapy
5. pregnant or planning pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Yoga program

Experimental group

Description:

12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.

Treatment:

Behavioral: Yoga program

Arthritis-education control

Active Comparator group

Description:

12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion.

Treatment:

Behavioral: Arthritis-education