Clinical trial NCT03500276: Yoga for Patients With Rheumatoid Arthritis
Official title: Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: yoga
health-related quality of life
proinflammatory genes
inflammatory markers
rheumatoid arthritis
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in pro-inflammatory gene expression
timeFrame: baseline and 12 weeks
measure: Change in blood levels of hs-CRP
timeFrame: baseline and 12 weeks
measure: Change in blood levels of hs-CRP
timeFrame: baseline and 24 weeks
measure: Change in pain intensity
timeFrame: baseline and 12 weeks
measure: Change in pain intensity
timeFrame: baseline and 24 weeks
measure: Change in perceived stress
timeFrame: baseline and 12 weeks
measure: Change in perceived stress
timeFrame: baseline and 24 weeks
measure: Change in rheumatoid arthritis activity
timeFrame: baseline and 12 weeks
measure: Change in rheumatoid arthritis activity
timeFrame: baseline and 24 weeks
measure: Change in fatigue intensity
timeFrame: baseline and 12 weeks
measure: Change in fatigue intensity
timeFrame: baseline and 24 weeks
measure: Change in anxiety and depression symptoms
timeFrame: baseline and 12 weeks
measure: Change in anxiety and depression symptoms
timeFrame: baseline and 24 weeks
measure: Change in rheumatoid arthritis impact of disease
timeFrame: baseline and 12 weeks
measure: Change in rheumatoid arthritis impact of disease
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Silva Pukšić, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Dubrava
name: Jadranka Morović-Vergles, MD, PhD
role: STUDY_CHAIR
References: