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Yoga for Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03500276
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
SILVA PUKŠIĆ, University Hospital Dubrava

Tracking Information
First Submitted Date  ICMJE April 7, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE April 4, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03500276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Patients With Rheumatoid Arthritis
Official Title  ICMJE Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description:
Blinded rater will be used to assess disease activity by DAS28CRP score.
Primary Purpose: Supportive Care
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Yoga program
  • 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.
    Intervention: Behavioral: Arthritis-education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Silva Pukšić, MD 00385989365148 puksic.silva@gmail.com
Listed Location Countries  ICMJE Croatia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03500276
Other Study ID Numbers  ICMJE DUBRAVA-YOGRA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SILVA PUKŠIĆ, University Hospital Dubrava
Study Sponsor  ICMJE University Hospital Dubrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silva Pukšić, MD University Hospital Dubrava
Study Chair: Jadranka Morović-Vergles, MD, PhD University Hospital Dubrava
PRS Account University Hospital Dubrava
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP