Yoga as Self-Care for Arthritis in Minority Communities
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Self-Efficacy Exercise [Baseline]
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.
- Self-Efficacy Exercise [8 weeks]
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.
- Health-Promoting Lifestyle Profile II Score [Baseline]
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.
- Health-Promoting Lifestyle Profile II Score [8 weeks]
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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
Investigators
- Principal Investigator: Kimberly R Middleton, R.N., National Institutes of Health Clinical Center (CC)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
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Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 18 |
| COMPLETED | 12 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 18 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
16
88.9%
|
| >=65 years |
2
11.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
94.4%
|
| Male |
1
5.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
13
72.2%
|
| Not Hispanic or Latino |
4
22.2%
|
| Unknown or Not Reported |
1
5.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
22.2%
|
| White |
7
38.9%
|
| More than one race |
1
5.6%
|
| Unknown or Not Reported |
6
33.3%
|
Outcome Measures
| Title | Self-Efficacy Exercise |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 12 |
| Mean (95% Confidence Interval) [units on a scale] |
6.1
|
| Title | Self-Efficacy Exercise |
|---|---|
| Description | 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. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 12 |
| Mean (95% Confidence Interval) [units on a scale] |
7.5
|
| Title | Health-Promoting Lifestyle Profile II Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 12 |
| Mean (95% Confidence Interval) [units on a scale] |
2.3
|
| Title | Health-Promoting Lifestyle Profile II Score |
|---|---|
| Description | 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. |
| Time Frame | 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Yoga |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 12 |
| Mean (95% Confidence Interval) [units on a scale] |
2.8
|
Adverse Events
| Time Frame | 8 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Yoga | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Yoga | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | |
Serious Adverse Events |
||
| Yoga | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Yoga | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/18 (27.8%) | |
| General disorders | ||
| Pain | 2/18 (11.1%) | 2 |
| Discomfort | 1/18 (5.6%) | 1 |
| Fatigue | 1/18 (5.6%) | 1 |
| Injury, poisoning and procedural complications | ||
| Fall | 1/18 (5.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Middleton, Kimberly |
|---|---|
| Organization | Clinical Center |
| Phone | +1 301 496 9083 |
| middletonk@mail.nih.gov |
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