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Yoga for Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Yoga program
Arthritis-education
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring yoga, health-related quality of life, proinflammatory genes, inflammatory markers, rheumatoid arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Dubrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga program

Arthritis-education control

Arm Description

12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in pro-inflammatory gene expression
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
hs-CRP (mg/l) changes from baseline to 12 weeks
Change in blood levels of hs-CRP
hs-CRP (mg/l) changes from baseline to 24 weeks
Change in pain intensity
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Change in pain intensity
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Change in perceived stress
Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
Change in perceived stress
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
April 7, 2018
Last Updated
May 11, 2020
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT03500276
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
yoga, health-related quality of life, proinflammatory genes, inflammatory markers, rheumatoid arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Blinded rater will be used to assess disease activity by DAS28CRP score.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga program
Arm Type
Experimental
Arm Description
12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.
Arm Title
Arthritis-education control
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Yoga program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Arthritis-education
Intervention Description
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 Outcome Measure Information:
Title
Change in health-related quality of life
Description
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
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in pro-inflammatory gene expression
Description
RT-PCR analysis of expression of a set of pro-inflammatory genes. Changes from baseline to 12 weeks
Time Frame
baseline and 12 weeks
Title
Change in blood levels of hs-CRP
Description
hs-CRP (mg/l) changes from baseline to 12 weeks
Time Frame
baseline and 12 weeks
Title
Change in blood levels of hs-CRP
Description
hs-CRP (mg/l) changes from baseline to 24 weeks
Time Frame
baseline and 24 weeks
Title
Change in pain intensity
Description
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Time Frame
baseline and 12 weeks
Title
Change in pain intensity
Description
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Time Frame
baseline and 24 weeks
Title
Change in perceived stress
Description
Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
Time Frame
baseline and 12 weeks
Title
Change in perceived stress
Description
Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
Time Frame
baseline and 24 weeks
Title
Change in rheumatoid arthritis activity
Description
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
Time Frame
baseline and 12 weeks
Title
Change in rheumatoid arthritis activity
Description
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
Time Frame
baseline and 24 weeks
Title
Change in fatigue intensity
Description
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
Time Frame
baseline and 12 weeks
Title
Change in fatigue intensity
Description
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
Time Frame
baseline and 24 weeks
Title
Change in anxiety and depression symptoms
Description
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.
Time Frame
baseline and 12 weeks
Title
Change in anxiety and depression symptoms
Description
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.
Time Frame
baseline and 24 weeks
Title
Change in rheumatoid arthritis impact of disease
Description
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.
Time Frame
baseline and 12 weeks
Title
Change in rheumatoid arthritis impact of disease
Description
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.
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silva Pukšić, MD
Organizational Affiliation
University Hospital Dubrava
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jadranka Morović-Vergles, MD, PhD
Organizational Affiliation
University Hospital Dubrava
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Yoga for Patients With Rheumatoid Arthritis

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