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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00349869
Other study ID # F31AT003362-01A1
Secondary ID F31AT003362-01A1
Status Completed
Phase N/A
First received
Last updated
Start date August 2006
Est. completion date August 2011

Study information

Verified date June 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Other known NCT identifiers
  • NCT00346307

Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date August 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
yoga
8-week yoga program.

Locations

Country Name City State
United States Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14 Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Health Assessed using SF36 Physical Component Score baseline, post intervention, follow-up
Secondary Mobility/Fitness Change in flexibility, balance, strength, walk time baseline, posttest, follow-up
Secondary RA Disease Activity DAS28 CRP score baseline, post intervention, follow-up
Secondary Psychological Function Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy baseline, , posttest, follow-up
Secondary HRQL Change in SF36 domains baseline, post intervention, follow-up
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