Yoga for Patients With Rheumatoid Arthritis

Overview

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 Title of Study: “Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2019

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.

Interventions

  • 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.
  • Behavioral: 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.

Arms, Groups and Cohorts

  • Experimental: Yoga program
    • 12 weeks of “Yoga in daily life practice”, 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.
  • Active Comparator: Arthritis-education control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in health-related quality of life
    • Time Frame: baseline and 12 weeks
    • 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

Secondary Measures

  • Change in pro-inflammatory gene expression
    • Time Frame: baseline and 12 weeks
    • RT-PCR analysis of expression of a set of pro-inflammatory genes. Changes from baseline to 12 weeks
  • Change in blood levels of hs-CRP
    • Time Frame: baseline and 12 weeks
    • hs-CRP (mg/l) changes from baseline to 12 weeks
  • Change in blood levels of hs-CRP
    • Time Frame: baseline and 24 weeks
    • hs-CRP (mg/l) changes from baseline to 24 weeks
  • Change in pain intensity
    • Time Frame: baseline and 12 weeks
    • Visual analogue scale 0-10, with higher scores indicating higher pain intensity
  • Change in pain intensity
    • Time Frame: baseline and 24 weeks
    • Visual analogue scale 0-10, with higher scores indicating higher pain intensity
  • Change in perceived stress
    • Time Frame: baseline and 12 weeks
    • Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
  • Change in perceived stress
    • Time Frame: baseline and 24 weeks
    • Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
  • Change in rheumatoid arthritis activity
    • Time Frame: baseline and 12 weeks
    • 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 × √[t28] + 0.28 × √[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity
  • Change in rheumatoid arthritis activity
    • Time Frame: baseline and 24 weeks
    • 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 × √[t28] + 0.28 × √[sw28] + 0.70 × Ln [CRP] + 0.014 × GH. Lower range 0, no higher range. Higher levels indicating higher disease activity
  • Change in fatigue intensity
    • Time Frame: baseline and 12 weeks
    • 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
  • Change in fatigue intensity
    • Time Frame: baseline and 24 weeks
    • 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
  • Change in anxiety and depression symptoms
    • Time Frame: baseline and 12 weeks
    • 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.
  • Change in anxiety and depression symptoms
    • Time Frame: baseline and 24 weeks
    • 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.
  • Change in rheumatoid arthritis impact of disease
    • Time Frame: baseline and 12 weeks
    • 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.
  • Change in rheumatoid arthritis impact of disease
    • Time Frame: baseline and 24 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Dubrava
  • Provider of Information About this Clinical Study
    • Principal Investigator: SILVA PUKŠIĆ, MD, PhD candidate – University Hospital Dubrava
  • Overall Official(s)
    • Silva Pukšić, MD, Principal Investigator, University Hospital Dubrava
    • Jadranka Morović-Vergles, MD, PhD, Study Chair, University Hospital Dubrava
  • Overall Contact(s)
    • Silva Pukšić, MD, 00385989365148, puksic.silva@gmail.com

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