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Yoga for Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00349869
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Behavioral: yoga Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessors masked to study condition
Primary Purpose: Treatment
Official Title: Yoga for Persons With Rheumatoid Arthritis
Study Start Date : August 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
8-week yoga program
Behavioral: yoga
8-week yoga program.

No Intervention: 2
Usual care control



Primary Outcome Measures :
  1. Physical Health [ Time Frame: baseline, post intervention, follow-up ]
    Assessed using SF36 Physical Component Score


Secondary Outcome Measures :
  1. Mobility/Fitness [ Time Frame: baseline, posttest, follow-up ]
    Change in flexibility, balance, strength, walk time

  2. RA Disease Activity [ Time Frame: baseline, post intervention, follow-up ]
    DAS28 CRP score

  3. Psychological Function [ Time Frame: baseline, , posttest, follow-up ]
    Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy

  4. HRQL [ Time Frame: baseline, post intervention, follow-up ]
    Change in SF36 domains



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349869


Locations
United States, Maryland
Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Susan J. Bartlett, Ph.D. Associate Professor of Medicine, Johns Hopkins Rheumatology

Additional Information:
Publications of Results:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00349869     History of Changes
Obsolete Identifiers: NCT00346307
Other Study ID Numbers: F31AT003362-01A1 ( U.S. NIH Grant/Contract )
F31AT003362-01A1 ( U.S. NIH Grant/Contract )
R24AT004641 ( U.S. NIH Grant/Contract )
Doctoral Dissertation Award ( Other Identifier: Arthritis Foundation )
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Johns Hopkins University:
inflammatory arthritis
rheumatoid arthritis
knee osteoarthritis
arthritis
yoga

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases