NCT01617421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

April 17, 2018

Enrollment Period

4.6 years

First QC Date

June 8, 2012

Results QC Date

June 11, 2019

Last Update Submit

July 2, 2019

Conditions

Keywords

YogaArthritis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

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.

Yoga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

  • 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.

    PMID: 23548052BACKGROUND
  • 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.

    PMID: 26667286BACKGROUND
  • 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.

    PMID: 30477826BACKGROUND
  • 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.

    PMID: 28434476BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

Yoga

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Limitations and Caveats

As some patients experienced arthritis pain prior to participating in yoga study, it's not easy to differentiate between pre-existing arthritis pain symptoms and effects of yoga practice.

Results Point of Contact

Title
Middleton, Kimberly
Organization
Clinical Center

Study Officials

  • Kimberly R Middleton, R.N.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Study Start

May 31, 2012

Primary Completion

January 3, 2017

Study Completion

January 3, 2017

Last Updated

July 16, 2019

Results First Posted

July 1, 2019

Record last verified: 2018-04-17

Locations