Rheumatoid ArthritisNCT00349869
Yoga for Rheumatoid Arthritis
A study testing yoga in people with Rheumatoid Arthritis and Osteoarthritis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis
- What is being tested?
- yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+ (RA only upper age limit 70)
- Confirmed or probable OA (using pre-specified criteria) OR Rheumatoid arthritis (participation approved by rheumatologist)
- Currently sedentary (physically active for 20 min < 3times/week)
Who cannot join
- Inability to ambulate without use of assistive device
- Uncontrolled high blood pressure or existing heart condition
- Co-morbid inflammatory condition with overlapping symptoms (i.e., fibromyalgia)
- Surgery within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14
Baltimore, Maryland, 21224
About this study
Official title: Yoga for Persons With Rheumatoid Arthritis
The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.
Read the detailed description
Yoga is a set of ancient Indian theories and practices, focusing on unifying mind, body, and spirit, and promoting strength, balance, and flexibility. The physical aspect of yoga includes poses, breathing techniques, and relaxation. Inflammatory arthritis, a chronic disease characterized by inflammation of the lining of the joints, can cause long-term joint damage, resulting in chronic pain, loss of function, and disability.
The primary objective of this study is to learn how people with inflammatory arthritis and knee osteoarthritis respond to an exercise program of yoga. To accomplish this, 30 persons with inflammatory arthritis or knee osteoarthritis will be randomly assigned to one of two groups. Group one will begin an immediate 8-week program of yoga classes consisting of 60-minute sessions, twice a week. Group two, or the "waitlist" control group, will receive 8 weeks of arthritis education followed by the same 8-week yoga program as group one. Participants also will have blood drawn, and complete various tests. The yoga classes will be taught by an experienced, certified yoga instructor, and are designed especially for the needs of people with inflammatory arthritis and knee osteoarthritis.
This study will provide important data on integrating mind-body activities into the treatment of inflammatory arthritis and knee osteoarthritis.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Being tested
- yoga
- Keywords
- inflammatory arthritis, rheumatoid arthritis, knee osteoarthritis, arthritis, yoga
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Arthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
8-week yoga program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 8-week yoga program Receives: Behavioral: yoga |
| 2 | No intervention | Usual care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Health
Assessed using SF36 Physical Component Score
Measured: baseline, post intervention, follow-up
Secondary outcomes (4)
Mobility/Fitness
Change in flexibility, balance, strength, walk time
Measured: baseline, posttest, follow-up
RA Disease Activity
DAS28 CRP score
Measured: baseline, post intervention, follow-up
Psychological Function
Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy
Measured: baseline, , posttest, follow-up
HRQL
Change in SF36 domains
Measured: baseline, post intervention, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Susan J. Bartlett, Ph.D., Principal investigator, Associate Professor of Medicine, Johns Hopkins Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349869
- Sponsor's protocol ID
- F31AT003362-01A1
- Other IDs
- F31AT003362-01A1, R24AT004641, Doctoral Dissertation Award
- Status last verified
- Jun 2023
- First submitted
- 6 Jul 2006
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bartlett SJ, Moonaz SH, Mill C, Bernatsky S, Bingham CO 3rd. Yoga in rheumatic diseases. Curr Rheumatol Rep. 2013 Dec;15(12):387. doi: 10.1007/s11926-013-0387-2.
PubMed 24173693Haaz S, Bartlett SJ. Yoga for arthritis: a scoping review. Rheum Dis Clin North Am. 2011 Feb;37(1):33-46. doi: 10.1016/j.rdc.2010.11.001. Epub 2010 Dec 3.
PubMed 21220084Haaz S, Bingham CO, Bathon JM, Bartlett SJ. The effect of yoga on clinical parameters in patients with rheumatoid arthritis. Arthritis & Rheumatism 2008;58:S893-S4.
Haaz S, Bingham III CO, Bartlett SJ. Adherence to an 8-week yoga program for RA and OA: Who drops out and why? Arthritis & Rheumatism 2009;60:1978.
Moonaz SH, Bingham CO 3rd, Wissow L, Bartlett SJ. Yoga in Sedentary Adults with Arthritis: Effects of a Randomized Controlled Pragmatic Trial. J Rheumatol. 2015 Jul;42(7):1194-202. doi: 10.3899/jrheum.141129. Epub 2015 Apr 1.
PubMed 25834206
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Persons With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00349869
- Acronym / sponsor ID
- F31AT003362-01A1
- Conditions
- Rheumatoid Arthritis, Osteoarthritis
- Keywords
- inflammatory arthritis, rheumatoid arthritis, knee osteoarthritis, arthritis, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Jul 2006 (estimated)
- 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 evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.
Detailed description
Yoga is a set of ancient Indian theories and practices, focusing on unifying mind, body, and spirit, and promoting strength, balance, and flexibility. The physical aspect of yoga includes poses, breathing techniques, and relaxation. Inflammatory arthritis, a chronic disease characterized by inflammation of the lining of the joints, can cause long-term joint damage, resulting in chronic pain, loss of function, and disability.
The primary objective of this study is to learn how people with inflammatory arthritis and knee osteoarthritis respond to an exercise program of yoga. To accomplish this, 30 persons with inflammatory arthritis or knee osteoarthritis will be randomly assigned to one of two groups. Group one will begin an immediate 8-week program of yoga classes consisting of 60-minute sessions, twice a week. Group two, or the "waitlist" control group, will receive 8 weeks of arthritis education followed by the same 8-week yoga program as group one. Participants also will have blood drawn, and complete various tests. The yoga classes will be taught by an experienced, certified yoga instructor, and are designed especially for the needs of people with inflammatory arthritis and knee osteoarthritis.
This study will provide important data on integrating mind-body activities into the treatment of inflammatory arthritis and knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: yoga8-week yoga program |
| 2 | No intervention | –Usual care control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+ (RA only upper age limit 70)
- Confirmed or probable OA (using pre-specified criteria) OR Rheumatoid arthritis (participation approved by rheumatologist)
- Currently sedentary (physically active for 20 min < 3times/week)
Key exclusion criteria (4 listed)
- Inability to ambulate without use of assistive device
- Uncontrolled high blood pressure or existing heart condition
- Co-morbid inflammatory condition with overlapping symptoms (i.e., fibromyalgia)
- Surgery within 6 months
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 |
|---|---|---|
| yoga8-week yoga program. | Behavioural | 1 |
Primary outcome
Physical Health
Time frame: baseline, post intervention, follow-up
Assessed using SF36 Physical Component Score
4 secondary outcomes
Mobility/Fitness
Time frame: baseline, posttest, follow-up
RA Disease Activity
Time frame: baseline, post intervention, follow-up
Psychological Function
Time frame: baseline, , posttest, follow-up
HRQL
Time frame: baseline, post intervention, follow-up
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 18 Jun 2023.
- Results publication: PubMed 24173693Bartlett SJ, Moonaz SH, Mill C, Bernatsky S, Bingham CO 3rd. Yoga in rheumatic diseases. Curr Rheumatol Rep. 2013 Dec;15(12):387. doi: 10.1007/s11926-013-0387-2.
- Results publication: PubMed 21220084Haaz S, Bartlett SJ. Yoga for arthritis: a scoping review. Rheum Dis Clin North Am. 2011 Feb;37(1):33-46. doi: 10.1016/j.rdc.2010.11.001. Epub 2010 Dec 3.
- Results publicationHaaz S, Bingham CO, Bathon JM, Bartlett SJ. The effect of yoga on clinical parameters in patients with rheumatoid arthritis. Arthritis & Rheumatism 2008;58:S893-S4.
- Results publicationHaaz S, Bingham III CO, Bartlett SJ. Adherence to an 8-week yoga program for RA and OA: Who drops out and why? Arthritis & Rheumatism 2009;60:1978.
- Results publication: PubMed 25834206Moonaz SH, Bingham CO 3rd, Wissow L, Bartlett SJ. Yoga in Sedentary Adults with Arthritis: Effects of a Randomized Controlled Pragmatic Trial. J Rheumatol. 2015 Jul;42(7):1194-202. doi: 10.3899/jrheum.141129. Epub 2015 Apr 1.
- Yoga for ArthritisLink provided by the sponsor.
Related trials for Rheumatoid Arthritis
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
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.
Susan J. Bartlett, Ph.D. principal investigator
Associate Professor of Medicine, Johns Hopkins Rheumatology
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 in people with Rheumatoid Arthritis and Osteoarthritis, run by Johns Hopkins University at 1 site in United States.
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 4 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 18 Jun 2023. 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 United States. 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?
Physical Health (time frame: baseline, post intervention, follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00349869, which also lists 5 linked publications.
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 18 Jun 2023.