Yoga for Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
yoga
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring inflammatory arthritis, rheumatoid arthritis, knee osteoarthritis, arthritis, yoga
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
8-week yoga program
Usual care control
Outcomes
Primary Outcome Measures
Physical Health
Assessed using SF36 Physical Component Score
Secondary Outcome Measures
Mobility/Fitness
Change in flexibility, balance, strength, walk time
RA Disease Activity
DAS28 CRP score
Psychological Function
Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy
HRQL
Change in SF36 domains
Full Information
NCT ID
NCT00349869
First Posted
July 6, 2006
Last Updated
June 14, 2023
Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00349869
Brief Title
Yoga for Rheumatoid Arthritis
Official Title
Yoga for Persons With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis
Keywords
inflammatory arthritis, rheumatoid arthritis, knee osteoarthritis, arthritis, yoga
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Assessors masked to study condition
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
8-week yoga program
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care control
Intervention Type
Behavioral
Intervention Name(s)
yoga
Intervention Description
8-week yoga program.
Primary Outcome Measure Information:
Title
Physical Health
Description
Assessed using SF36 Physical Component Score
Time Frame
baseline, post intervention, follow-up
Secondary Outcome Measure Information:
Title
Mobility/Fitness
Description
Change in flexibility, balance, strength, walk time
Time Frame
baseline, posttest, follow-up
Title
RA Disease Activity
Description
DAS28 CRP score
Time Frame
baseline, post intervention, follow-up
Title
Psychological Function
Description
Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy
Time Frame
baseline, , posttest, follow-up
Title
HRQL
Description
Change in SF36 domains
Time Frame
baseline, post intervention, follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J. Bartlett, Ph.D.
Organizational Affiliation
Associate Professor of Medicine, Johns Hopkins Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24173693
Citation
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.
Results Reference
result
PubMed Identifier
21220084
Citation
Haaz 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 Reference
result
Citation
Haaz 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 Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
25834206
Citation
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.
Results Reference
result
Links:
URL
http://www.hopkinsarthritis.org/patient-corner/disease-management/yoga-for-arthritis/
Description
Yoga for Arthritis
Learn more about this trial
Yoga for Rheumatoid Arthritis
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