Rheumatoid ArthritisNCT03500276
Yoga for Patients With Rheumatoid Arthritis
A study testing Yoga program and Arthritis-education in people with Rheumatoid Arthritis, run by University Hospital Dubrava at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Yoga program and Arthritis-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCroatia
- Study dates
- 4 Apr 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Yoga program, Arthritis-education
- Keywords
- yoga, health-related quality of life, proinflammatory genes, inflammatory markers, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga programBehavioural
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-educationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Yoga program | Experimental | 12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises. Receives: Behavioral: Yoga program |
| Arthritis-education control | Active comparator | 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. Receives: Behavioral: Arthritis-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 12 weeks
Secondary outcomes (15)
Change in pro-inflammatory gene expression
RT-PCR analysis of expression of a set of pro-inflammatory genes. Changes from baseline to 12 weeks
Measured: baseline and 12 weeks
Change in blood levels of hs-CRP
hs-CRP (mg/l) changes from baseline to 12 weeks
Measured: baseline and 12 weeks
Change in blood levels of hs-CRP
hs-CRP (mg/l) changes from baseline to 24 weeks
Measured: baseline and 24 weeks
Change in pain intensity
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Measured: baseline and 12 weeks
Change in pain intensity
Visual analogue scale 0-10, with higher scores indicating higher pain intensity
Measured: baseline and 24 weeks
Change in perceived stress
Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
Measured: baseline and 12 weeks
Change in perceived stress
Perceived Stress Scale (PSS) consists of 10 items. Range 0-40 points with higher scores indicating greater levels of stress
Measured: baseline and 24 weeks
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
Measured: baseline and 12 weeks
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
Measured: baseline and 24 weeks
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
Measured: baseline and 12 weeks
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
Measured: baseline and 24 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 24 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start4 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SILVA PUKŠIĆ, University Hospital Dubrava
- Investigators
- Silva Pukšić, MD, Principal investigator, University Hospital DubravaJadranka Morović-Vergles, MD, PhD, Study chair, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500276
- Sponsor's protocol ID
- DUBRAVA-YOGRA-01
- Status last verified
- May 2020
- First submitted
- 7 Apr 2018
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yoga on Quality of Life and Markers of Inflammation in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT03500276
- Acronym / sponsor ID
- DUBRAVA-YOGRA-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- yoga, health-related quality of life, proinflammatory genes, inflammatory markers, rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Yoga program | Experimental | Behavioral: Yoga program12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises. |
| Arthritis-education control | Active comparator | Behavioral: Arthritis-education12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga programYoga 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. | Behavioural | Yoga program |
| Arthritis-educationArthritis-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. | Behavioural | Arthritis-education control |
Primary outcome
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
15 secondary outcomes
Change in pro-inflammatory gene expression
Time frame: baseline and 12 weeks
Change in blood levels of hs-CRP
Time frame: baseline and 12 weeks
Change in blood levels of hs-CRP
Time frame: baseline and 24 weeks
Change in pain intensity
Time frame: baseline and 12 weeks
Change in pain intensity
Time frame: baseline and 24 weeks
Change in perceived stress
Time frame: baseline and 12 weeks
Change in perceived stress
Time frame: baseline and 24 weeks
Change in rheumatoid arthritis activity
Time frame: baseline and 12 weeks
Change in rheumatoid arthritis activity
Time frame: baseline and 24 weeks
Change in fatigue intensity
Time frame: baseline and 12 weeks
Change in fatigue intensity
Time frame: baseline and 24 weeks
Change in anxiety and depression symptoms
Time frame: baseline and 12 weeks
Change in anxiety and depression symptoms
Time frame: baseline and 24 weeks
Change in rheumatoid arthritis impact of disease
Time frame: baseline and 12 weeks
Change in rheumatoid arthritis impact of disease
Time frame: baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silva Pukšić, MD principal investigator
University Hospital Dubrava
Jadranka Morović-Vergles, MD, PhD study chair
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga program and Arthritis-education in people with Rheumatoid Arthritis, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.