Effect of Chair Yoga on Elders With Osteoarthritis
Effect of Sit 'N' Fit Chair Yoga on Community-Dwelling Elders With Osteoarthritis
2 other identifiers
interventional
131
1 country
2
Brief Summary
The current study is a two-arm randomized controlled clinical trial to test the feasibility of recruiting, randomizing, and having older adults with osteoarthritis (OA) adhere to and safely complete the 8-week Sit 'N' Fit Chair Yoga program and the HEP program (primary objective). Secondary objectives of the study were to determine the effect of the Sit 'N' Fit Chair Yoga Program to reduce levels of pain; improve physical function, psychosocial function, and life satisfaction in adults over 65 years of age who were unable to participate in standing exercise. Participants at two sites were randomly assigned to either the intervention group (Sit 'N' Fit Chair Yoga) or attention control group (Health Education Program). Data collectors were blinded to group assignments. Data were collected prior to the intervention (baseline), after 4 weeks, and after 8 weeks. Follow-up data were collected after 1 month and after 3 months after completion of the intervention to measure the extent to which effects of the intervention continue. Evaluations were include physical measures and self-report measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Typical duration for not_applicable
2 active sites
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
September 17, 2019
CompletedSeptember 17, 2019
August 1, 2019
1.3 years
April 8, 2014
April 9, 2018
August 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PROMIS Pain Interference
The 8-item PROMIS Pain Inference-Short Form- V. 1.0-8a was administered to measure self-reported consequences of pain on various aspects of the participant's life.Scores can range from 8 (minimum) to 40 (maximum) and higher scores indicate more interference with daily activities. This tool is normed on the U.S. general population, with an average score of 50 and a standard deviation of 10, to report interference within the previous 7 days on 5-point response scale ranging from not at all to very much. This self-report measure was developed by the NIH. NIH has rigorously tested the construct validity and reliability of all of the PROMIS tools and all have been shown to be internally consistent, reliable (reliability = .96 to .99, for PROMIS-PI SF) and valid (construct validity). A higher score represent a severe pain level.
6 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Osteoarthritis Index was administered to measure self-reported. The tool, recommended for osteoarthritis clinical trials, is a self-administered scale with 24 questions using a Likert-type scale. The Western Ontario and McMaster Universities Osteoarthritis Index was administered to measure self-reported OA symptoms (pain, stiffness, functional ability). The tool is a self-administered scale with 24 items (pain \[5 items\], stiffness \[2 items\], physical function \[17 items\]). A score range for each subscale for each scale (minimum-maximum) is Pain 0-20, stiffness 0-8, physical function 0-68. Higher scores indicate worse pain, stiffness, and functional limitations. For this study, we used a subscale of pain (5 items), stiffness (2 items), physical function (17 items). A total score of all subscales can range from 0 (minimum) to 96 (maximum). The WOMAC demonstrated a Cronbach's alpha of .95 for persons with OA.
6 months
Secondary Outcomes (8)
PROMIS Physical Function
6 months
Gait Speed Test
6 months
Berg Balance Scale
6 months
6-Minute Walk Test
6 months
PROMIS Emotional Distress-Depression (Short Form)
6 months
- +3 more secondary outcomes
Study Arms (2)
Sit 'N' Fit Chair Yoga (SNFCY)
EXPERIMENTALWilling and eligible subjects randomized to Sit 'N' Fit Chair Yoga attended twice-weekly 45-minute yoga sessions for 8 weeks, for a total of 16 sessions.
Health Education Program (HEP)
ACTIVE COMPARATORWilling and eligible subjects randomized to the Health Education Program (HEP) will attended twice-weekly 45-minute health education sessions for 8 weeks, for a total of 16 sessions.
Interventions
Experimental: Sit 'N' Fit Chair Yoga - a twice-weekly, 8-week yoga program of 45-minute sessions. Active Comparator: Health Education Program (HEP), a twice-weekly, 8-week program of 45-minute sessions
Willing and eligible subjects randomized to the Health Education Program (HEP) attended twice-weekly 45-minute health education sessions for 8 weeks, for a total of 16 sessions.
Eligibility Criteria
You may qualify if:
- age 65 years or older
- living independently in the community and noninstitutionalized at the time of the study
- self-reported joint pain verified by Dr. McCaffrey and a Project Director (nurse practitioner) to be caused by OA and present in one or more lower extremity joints (hip, knee, foot, or ankle)
- ability to ambulate independently with or without assistive devices
- chronic pain at least 15 days of the month for 3 months or longer at a level of at least 4 (moderate pain) on a 0-10 pain bothersomeness scale (0 = no pain to 10 = excruciating pain)
- self-reported inability to participate in regular yoga or standing exercise due to physical disability, fatigue, fear of falling, or balance problems
- not currently participating in yoga or any other exercise program
- ability to understand English or Spanish
- ability to come to designated site at the scheduled times
- willingness to be audiotaped during the intervention sessions
You may not qualify if:
- Knee surgery (or knee-arthroscopy) or hip(s) within 12 weeks prior to enrollment, causing pain or functional problems
- Systemic or intra-articular corticosteroid use within 60 days of the screening visit
- Serious comorbidity that makes it impossible to participate in the yoga intervention (e.g., heart failure-New York Heart Association (NYHA IV)
- Require assistance by another person (e.g., holding the arm or walking behind) in order to ambulate 30 feet
- Participation in yoga or exercise program currently or in the previous 3 months, or planning to participate in yoga or other exercise program during the chair yoga intervention (including 3-month follow-up)
- Intra-articular steroid injections within 4 weeks of screening
- Inability to understand or speak English or Spanish
- Inability to correctly answer questions, complete the demographic data form, and continue with yoga practice for 1 month post intervention. This is measured by asking participants the following questions (Alzheimer's Association's "questions to determine early cognitive impairment) (http://www.alz.org/alzheimers\_disease\_10\_signs\_of\_alzheimers.asp) as accessed August 27, 2013, as approved by our geriatric content expert, Dr. Joseph Ouslander).
- Those who answer three or more of these questions incorrectly are excluded from the study.
- \. What is today's date? 2. What day of the week is today? 3. On what street do you live? 4. In what town do you live? 5. In what state is your town? 6. Who is the President? 7. What season of the year is this? 8. What month are we in now? 9. How did you get here today?
- Screening Evaluation
- All participants must have OA. As diagnostic criteria for OA, the participant must exhibit at least three of the following upon history or physical examination to be considered to have a diagnosis of OA and thus to be eligible to participate in the study:
- Pain in the affected joint
- Morning stiffness that is relieved as the day progresses
- Crepitus on active motion
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
North East Focal Point Senior Center
Deerfield Beach, Florida, 33441, United States
Douglas Gardens North (Public Housing Facility)
Pembroke Pines, Florida, 33025, United States
Related Publications (2)
Park J, McCaffrey R, Newman D, Liehr P, Ouslander JG. A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis. J Am Geriatr Soc. 2017 Mar;65(3):592-597. doi: 10.1111/jgs.14717. Epub 2016 Dec 23.
PMID: 28008603DERIVEDMcCaffrey R, Park J, Newman D. Chair Yoga: Feasibility and Sustainability Study With Older Community-Dwelling Adults With Osteoarthritis. Holist Nurs Pract. 2017 May/Jun;31(3):148-157. doi: 10.1097/HNP.0000000000000184.
PMID: 27782922DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Juyoung Park
- Organization
- Florida Atlantic University
Study Officials
- PRINCIPAL INVESTIGATOR
Juyoung Park, Ph. D
Florida Atlantic University
- PRINCIPAL INVESTIGATOR
Patricia Liehr, Ph.D.
Florida Atlantic University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 14, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2015
Study Completion
September 1, 2016
Last Updated
September 17, 2019
Results First Posted
September 17, 2019
Record last verified: 2019-08