Yoga for Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500276
• Other study ID #: DUBRAVA-YOGRA-01
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Yoga program
Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.
• Arthritis-education
Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health-related quality of life	The Medical Outcomes Survey 36-item Short-Form Healthy Survey ( SF-36). A 36 item generic health survey measures general health concepts through 8 domains: physical functioning, role physical, bodily pain, global health, vitality, social functioning, role emotional, mental health. Scores 0-100, with higher scores indicating better health	baseline and 12 weeks
Secondary	Change in pro-inflammatory gene expression	RT-PCR analysis of expression of a set of pro-inflammatory genes. Changes from baseline to 12 weeks	baseline and 12 weeks
Secondary	Change in blood levels of hs-CRP	hs-CRP (mg/l) changes from baseline to 12 weeks	baseline and 12 weeks
Secondary	Change in blood levels of hs-CRP	hs-CRP (mg/l) changes from baseline to 24 weeks	baseline and 24 weeks
Secondary	Change in pain intensity	Visual analogue scale 0-10, with higher scores indicating higher pain intensity	baseline and 12 weeks
Secondary	Change in pain intensity	Visual analogue scale 0-10, with higher scores indicating higher pain intensity	baseline and 24 weeks
Secondary	Change in perceived stress	Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress	baseline and 12 weeks
Secondary	Change in perceived stress	Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress	baseline and 24 weeks
Secondary	Change in rheumatoid arthritis activity	Disease Activity Score 28 (DAS28CRP). Composite index including a non-graded 28 tender and swollen joint count, patients global health (VAS-GH scored 0-100), and CRP in mg/l. It is based on a complex equasion DAS28 = 0.56 × v[t28] + 0.28 × v[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity	baseline and 12 weeks
Secondary	Change in rheumatoid arthritis activity	Disease Activity Score 28 (DAS28CRP). Composite index including a non-graded 28 tender and swollen joint count, patients global health (VAS-GH scored 0-100), and CRP in mg/l. It is based on a complex equasion DAS28 = 0.56 × v[t28] + 0.28 × v[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity	baseline and 24 weeks
Secondary	Change in fatigue intensity	Functional assessment of chronic illness therapy - fatigue (FACIT-F) scale consisting of 13 items. Range 0-52 with higher scores indicating higher levels of fatigue	baseline and 12 weeks
Secondary	Change in fatigue intensity	Functional assessment of chronic illness therapy - fatigue (FACIT-F) scale consisting of 13 items. Range 0-52 with higher scores indicating higher levels of fatigue	baseline and 24 weeks
Secondary	Change in anxiety and depression symptoms	Hospital anxiety and depression scale (HADS) measures levels of anxiety and depression (total score range 0-42 points) consists of subscale for anxiety 0-21 points and sub-scale for depression 0-21 points. Higher scores indicate higher levels of anxiety / depression.	baseline and 12 weeks
Secondary	Change in anxiety and depression symptoms	Hospital anxiety and depression scale (HADS) measures levels of anxiety and depression (total score range 0-42 points) consists of subscale for anxiety 0-21 points and sub-scale for depression 0-21 points. Higher scores indicate higher levels of anxiety / depression.	baseline and 24 weeks
Secondary	Change in rheumatoid arthritis impact of disease	Rheumatoid arthritis impact of disease questionnaire (RAID) is a patient-derived scores assessing 7 most important domains of impact of rheumatoid arthritis. Domains include pain, functional disability, fatigue, emotional and physical well-being, sleep and coping. Range 0-10.Higher scores reflect higher levels of symptoms.	baseline and 12 weeks
Secondary	Change in rheumatoid arthritis impact of disease	Rheumatoid arthritis impact of disease questionnaire (RAID) is a patient-derived scores assessing 7 most important domains of impact of rheumatoid arthritis. Domains include pain, functional disability, fatigue, emotional and physical well-being, sleep and coping. Range 0-10.Higher scores reflect higher levels of symptoms.	baseline and 24 weeks