Yoga as Self-Care for Arthritis in Minority Communities

Rheumatoid Arthritis Clinical Trial

Official title:

Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617421
• Other study ID #: 120145
• Secondary ID: 12-CC-0145
• Status: Completed
• Phase: N/A
• Start date: May 31, 2012
• Est. completion date: January 3, 2017

Study information

• Verified date: April 17, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 self-care 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, rheumatoid arthritis or systemic lupus erythematosus (SLE).

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 RA/OA participants and 5 SLE 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 3, 2017
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

-

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Yoga
This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Middleton KR, Andrade R, Moonaz SH, Muhammad C, Wallen GR. Yoga Research and Spirituality: A Case Study Discussion. Int J Yoga Therap. 2015;25(1):33-5. doi: 10.17761/1531-2054-25.1.33. — View Citation

Middleton KR, Haaz Moonaz S, Hasni SA, Magaña López M, Tataw-Ayuketah G, Farmer N, Wallen GR. Yoga for systemic lupus erythematosus (SLE): Clinician experiences and qualitative perspectives from students and yoga instructors living with SLE. Complement Ther Med. 2018 Dec;41:111-117. doi: 10.1016/j.ctim.2018.09.001. Epub 2018 Sep 8. — View Citation

Middleton KR, Magaña López M, Haaz Moonaz S, Tataw-Ayuketah G, Ward MM, Wallen GR. A qualitative approach exploring the acceptability of yoga for minorities living with arthritis: 'Where are the people who look like me?' Complement Ther Med. 2017 Apr;31:82-89. doi: 10.1016/j.ctim.2017.02.006. Epub 2017 Mar 1. — View Citation

Middleton KR, Ward MM, Haaz Moonaz S, Magaña López M, Tataw-Ayuketah G, Yang L, Acevedo AT, Brandon Z, Wallen GR. Feasibility and assessment of outcome measures for yoga as self-care for minorities with arthritis: a pilot study. Pilot Feasibility Stud. 20 — View Citation

Middleton KR, Ward MM, Haaz S, Velummylum S, Fike A, Acevedo AT, Tataw-Ayuketah G, Dietz L, Mittleman BB, Wallen GR. A pilot study of yoga as self-care for arthritis in minority communities. Health Qual Life Outcomes. 2013 Apr 2;11:55. doi: 10.1186/1477-7525-11-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Efficacy Exercise	The Chronic Disease Self-Efficacy-Exercise Regularly Scale is a 3-item scale used to measure confidence in exercising regularly based on a Likert scale from 1 (not at all confident) to 10 (totally confident). The mean value was calculated based on participant responses to all three items.	Baseline
Primary	Self-Efficacy Exercise	The Chronic Disease Self-Efficacy-Exercise Regularly Scale is a 3-item scale used to measure confidence in exercising regularly based on a Likert scale from 1 (not at all confident) to 10 (totally confident). The mean value was calculated based on participant responses to all three items.	8 weeks
Primary	Health-Promoting Lifestyle Profile II Score	Health Promoting Lifestyle Profile (HPLP II) was used to measure the extent to which adults engage in a health-promoting lifestyle - Likert-type scales ranged from (1-never to 4-routinely). Subscales included: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management. The mean value was calculated based on participant responses to all six subscales.	Baseline
Primary	Health-Promoting Lifestyle Profile II Score	Health Promoting Lifestyle Profile (HPLP II) was used to measure the extent to which adults engage in a health-promoting lifestyle - Likert-type scales ranged from (1-never to 4-routinely). Subscales included: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management. The mean value was calculated based on participant responses to all six subscales.	8 weeks

External Links

•   NIH Clinical Center Detailed Web Page