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Trial record 5 of 16 for:    +yoga+arthritis

Yoga for Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 6, 2006
First Posted Date  ICMJE July 10, 2006
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Physical Health [ Time Frame: baseline, post intervention, follow-up ]
Assessed using SF36 Physical Component Score
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
quality of life
Change History Complete list of historical versions of study NCT00349869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
  • Mobility/Fitness [ Time Frame: baseline, posttest, follow-up ]
    Change in flexibility, balance, strength, walk time
  • RA Disease Activity [ Time Frame: baseline, post intervention, follow-up ]
    DAS28 CRP score
  • Psychological Function [ Time Frame: baseline, , posttest, follow-up ]
    Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy
  • HRQL [ Time Frame: baseline, post intervention, follow-up ]
    Change in SF36 domains
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
  • physical function
  • disease activity
  • medication use
  • C-reactive protein (CRP)
  • swollen/tender joint count
  • Arthritis Impact Measurement Scale (AIMS 2-SF)
  • 6-minute walk test
  • CES-D
  • PANAS
  • SF-36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Rheumatoid Arthritis
Official Title  ICMJE Yoga for Persons With Rheumatoid Arthritis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Rheumatoid Arthritis
  • Osteoarthritis
Intervention  ICMJE Behavioral: yoga
8-week yoga program.
Study Arms  ICMJE
  • Experimental: 1
    8-week yoga program
    Intervention: Behavioral: yoga
  • No Intervention: 2
    Usual care control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
75
Original Enrollment  ICMJE
 (submitted: July 6, 2006)
30
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00349869
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Susan J. Bartlett, Ph.D. Associate Professor of Medicine, Johns Hopkins Rheumatology
PRS Account Johns Hopkins University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP