Rheumatoid ArthritisNCT01617421
Yoga as Self-Care for Arthritis in Minority Communities
A study testing Yoga in people with Rheumatoid Arthritis and Arthritis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2012to 3 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities
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.
Read more
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Arthritis
- Being tested
- Yoga
- Keywords
- Yoga, Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 8 weeks
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.
Measured: Baseline
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start31 May 2012
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kimberly R Middleton, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617421
- Sponsor's protocol ID
- 120145
- Other IDs
- 12-CC-0145
- Status last verified
- 17 Apr 2018
- First submitted
- 8 Jun 2012
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23548052Middleton 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.
PubMed 26667286Middleton 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.
PubMed 30477826Middleton 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.
PubMed 28434476Middleton 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.
PubMed 29484197
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Yoga as Self-Care for Arthritis in Minority Communities
- ClinicalTrials.gov ID
- NCT01617421
- Acronym / sponsor ID
- 120145
- Conditions
- Rheumatoid Arthritis, Arthritis
- Keywords
- Yoga, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 31 May 2012
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaThis 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. | Behavioural | Yoga |
Primary outcome
Self-Efficacy Exercise
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23548052Middleton 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.
- Background: PubMed 26667286Middleton 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.
- Background: PubMed 30477826Middleton 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.
- Background: PubMed 28434476Middleton 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.
- Results publication: PubMed 29484197Middleton 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly R Middleton, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Rheumatoid Arthritis and Arthritis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy Exercise (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617421, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.