Rheumatoid Arthritis Clinical Trial
Official title:
Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities
Verified date | April 17, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
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
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 |
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