Yoga as Self-Care for Arthritis in Minority Communities

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01617421
First received: June 8, 2012
Last updated: April 2, 2014
Last verified: January 2014
  Purpose

Background:

  • People with arthritis should be active. Regular exercise leads to less pain, more energy, improved sleep, and better day-to-day function. Yet arthritis is one of the most common reasons people give for limiting activities.
  • Yoga for arthritis has been studied before. However, few studies have included minorities. Making changes to yoga classes based on language and culture may help people use yoga to care for their arthritis symptoms. Researchers want to see if minority populations with arthritis will come to and benefit from yoga classes.

Objectives:

- To see if yoga classes designed for people with arthritis will be acceptable to minorities with arthritis.

Eligibility:

  • Adults at least 18 years of age who are enrolled in the Natural History of Rheumatic Disease in Minority Communities study.
  • Participants will have osteoarthritis or rheumatoid arthritis.
  • Participants will be able to speak and read English or Spanish.

Design:

  • The total study period covers 10 weeks.
  • The first study visit will include an initial questionnaire about health and arthritis. Participants will also have a physical exam.
  • Participants will have yoga classes twice a week for 8 weeks. The classes will be 1 hour long each.
  • After completing the yoga classes, participants will complete another questionnaire about their health. They will have a final physical exam.
  • Follow-up contact will be made 3 months after the end of the study.

Condition Intervention Phase
Rheumatoid Arthritis
Arthritis
Behavioral: Yoga
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine the feasibility and acceptability of providing yoga to an urban, minority population with arthritis

Secondary Outcome Measures:
  • To determine the appropriateness of specific physical and psychosocial measures for this population and intervention

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Yoga
    N/A
Detailed Description:

BACKGROUND:

Arthritis is the most common cause of disability, and is associated with activity limitation, work disability and significant health care costs. Approximately 50 million US adults have doctor-diagnosed arthritis. Non-Hispanic blacks and Hispanics have worse arthritis impact despite having the same or lower prevalence of arthritis compared to non-Hispanic whites. People with arthritis who exercise regularly have less pain, more energy, improved sleep and better day-to-day function. Yet, arthritis is one of the most common reasons for limiting physical activity. Improving health quality for people with chronic disease requires patients to take responsibility for their own care. Self-efficacy enhancing interventions may enable individuals to undertake selfcare activities that improve physical and mental well-being. Attention is now being focused on complementary and integrated non-pharmacologic self-care approaches. Yoga is among the top 10 complementary and alternative medicine (CAM) modalities. Stretching, strength, posture, balance, and the ability to adjust pace and intensity are important safety components for patients with arthritis, all of which yoga encompasses.

Mind-body interventions, such as yoga, that teach stress management with physical activity may be well suited for investigation in both osteoarthritis (OA) and rheumatoid arthritis (RA). Yoga users are predominately white, female, and college educated. In a descriptive study of patients enrolled in the Natural History of Rheumatic Disease in Minority Communities protocol only 4.6% were doing yoga. These disparities may be related to cost, access, and cultural beliefs. There are few studies that examine yoga in minority populations; none of these address arthritis.

STUDY OBJECTIVE:

The primary objective of this study is to determine the feasibility and acceptability of providing yoga to an urban, minority population with arthritis.

Secondary Objective: To determine the appropriateness of specific physical and psychosocial measures for this population, and intervention with a focus on physical function and patient reported measures.

Tertiary Objective: To determine the feasibility of using computerized self-interview (with assistance) to capture baseline and final status.

ELIGIBILITY:

Adult patients (18 years or older) enrolled in the Natural History of Rheumatoid Disease in Minority Communities protocol with a diagnosis of osteoarthritis or rheumatoid arthritis.

DESIGN:

A pilot study to evaluate the feasibility and acceptability of conducting a study based on a yoga intervention for arthritis in minority communities. Assessments will be made from a convenience sample of 20 participants undergoing an 8-week program of yoga classes consisting of 60-minute sessions, twice a week. The yoga classes are designed especially for people with arthritis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

-

INCLUSION CRITERIA:

- Adult patients enrolled in the NIAMS Natural History of

Rheumatic Disease in Minority Communities

  • Diagnosis of osteoarthritis (OA) or rheumatoid arthritis (RA)
  • Willingness and ability to provide informed consent
  • Age greater than or equal to 18 years

EXCLUSION CRITERIA:

  • Recent (less than 6 months) or planned joint surgery
  • Use of assistive ambulatory devices
  • Other significant medical or psychiatric conditions, including other inflammatory conditions
  • Hyper-mobility or unstable disease that could compromise participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617421

Contacts
Contact: Kimberly R Middleton, R.N. (301) 496-9083 middletonk@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Kimberly R Middleton, R.N. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01617421     History of Changes
Other Study ID Numbers: 120145, 12-CC-0145
Study First Received: June 8, 2012
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Yoga
Arthritis

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

ClinicalTrials.gov processed this record on August 20, 2014