Skip to main content
OpenTrials
Completed

NCT Number: NCT03500276

Yoga for Patients With Rheumatoid Arthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dubrava

Zagreb, 10 000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA)
  • disease activity measured by DAS28CRP< 5.1
  • 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

  • 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
  • history of drug or alcohol abuse
  • recent injury/ or surgery
  • 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
  • pregnant or planning pregnancy

Treatment and study plan

Yoga Program

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change in blood levels of hs-CRP

    Time frame: baseline and 12 weeks

    hs-CRP (mg/l) changes from baseline to 12 weeks

  3. Change in blood levels of hs-CRP

    Time frame: baseline and 24 weeks

    hs-CRP (mg/l) changes from baseline to 24 weeks

  4. Change in pain intensity

    Time frame: baseline and 12 weeks

    Visual analogue scale 0-10, with higher scores indicating higher pain intensity

  5. Change in pain intensity

    Time frame: baseline and 24 weeks

    Visual analogue scale 0-10, with higher scores indicating higher pain intensity

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2018
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.