Clinical trial NCT01617421: Yoga as Self-Care for Arthritis in Minority Communities
Official title: Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Arthritis
Keywords: Yoga
Arthritis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2012-06-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Self-Efficacy Exercise
timeFrame: Baseline
measure: Self-Efficacy Exercise
timeFrame: 8 weeks
measure: Health-Promoting Lifestyle Profile II Score
timeFrame: Baseline
measure: Health-Promoting Lifestyle Profile II Score
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Kimberly R Middleton, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Middleton KR, Haaz Moonaz S, Hasni SA, Magana Lopez 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.
citation: Middleton KR, Magana Lopez 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.
citation: Middleton KR, Ward MM, Haaz Moonaz S, Magana Lopez 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. 2018 Feb 20;4:53. doi: 10.1186/s40814-018-0248-x. eCollection 2018.