Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia
Primary Purpose
Osteoarthritis, Knee, Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Attention control
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, knee, Cognitive impairment, Tai Chi
Eligibility Criteria
Inclusion Criteria:
- Age 60 years or order;
- A MMSE score of 18-28;
- Diagnosis of knee OA based on medical history reviewed with elders or family members/staff and confirmation from the physician/APN;
- Self-report of knee OA pain ≥ 2 on the VDS, or pain score ≥ 3 on the WOMAC pain subscale;
- Ability to speak English;
- Physician's/APN's permission to participate;
- No regular exercise program in the past month;
- Ambulation without assistance from staff or a walking device for 50 meters; and
- Ability to stand and maintain balance for 1 minute without a walking device
Exclusion Criteria:
- Uncorrectable moderate or severe hearing or vision deficits;
- Parkinson's disease;
- Cancer pain;
- Chronic pain conditions, such as rheumatoid arthritis, fibromyalgia, or severe low back pain;
- Diabetic neuropathy;
- Arthroscopic surgery or total knee- or hip-replacement surgery in the past 6 months;
- Fractures in the past 6 months;
- Major psychiatric disorder or positive screen for depressive symptoms (GDS-15 score ≥ 5) without taking medication;
- History of falls in the past 3 months; or
- Vertigo in the past month
Sites / Locations
- University of Arkansas for Medical asciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tai Chi
Attentation control
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in pain at Week 5
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Change from baseline in pain at Week 9
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Change from baseline in pain at Week 13
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Change from baseline in pain at Week 17
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Change from baseline in pain at Week 21
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Secondary Outcome Measures
Physical function
Measured by 1). WOMAC Physical Function subscale; and 2). Get Up and Go (GUG)
Cognitive function
Mini Mental Status Exam (MMSE)
Stiffness
WOMAC Stiffness subscale
Quadriceps strength
Measured by the Sit-To-Stand (STS)
Pain level (each session)
Measured by the Verbal Descriptor Scale (VDS)
Full Information
NCT ID
NCT01528566
First Posted
January 24, 2012
Last Updated
February 3, 2012
Sponsor
University of Arkansas
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01528566
Brief Title
Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia
Official Title
Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is the first study to test the effect of Tai Chi on pain from knee osteoarthritis in community-dwelling elders with mild cognitive impairment. If Tai Chi is effective in reducing pain, clinicians can use it routinely with this population; then elders can maintain their functional ability longer, and perhaps delay or prevent long-term care admission, and the investigators can save health care dollars.
Detailed Description
Up to 33% of all elders and 40% of elders over age 70 experience knee osteoarthritis (OA), a leading cause of pain and disability. Further, up to 15.3% of elders age 65 have CI, and the prevalence of cognitive impairment (CI) doubles every 5 years after age 65. The prevalence of OA in elders with CI is comparable to that in elders without CI. Cognitive impairment limits elders' ability to perform daily activities, and their functional capacity declines more rapidly than in elders without CI. Having knee OA pain in addition to CI further limits elders' activities. Without proper treatment of knee OA pain, elders with CI may avoid basic daily activities, such as rising, walking, standing, and climbing stairs because these aggravate pain. By avoiding these basic activities, they gradually lose muscle strength, range of motion, and mobility, which leads to further physical deconditioning and social isolation. With aging of the baby boomers and advances in health care, the number of elders with both CI and OA will increase fourfold by 2050. Alleviating knee pain in elders with CI and knee OA could preserve their functioning, perhaps delay institutionalization, and save healthcare dollars. Since pharmacological interventions produce serious side effects and inadequately reduce pain, especially in elders with CI, adjuncts such as Tai Chi (TC) are needed. A low-impact aerobic exercise, TC involves slowly stretching the limbs and trunk and ultimately re-establishes normal mechanics of the knee joints, which reduces knee OA pain. The United States Arthritis Foundation and the American Geriatrics Society have endorsed TC to reduce knee OA pain; but no study has investigated the effect of TC on knee OA pain in elders with CI. The primary aims of this study are:
To test the efficacy of a modified TC program in reducing knee OA pain in community-dwelling elders with mild CI.
To test the efficacy of a modified TC program in improving physical function and quadriceps strength.
To investigate feasibility and compliance issues in conducting TC.
To estimate the clinical significance of TC for pain reduction in community dwelling elders with mild CI.
The results of this study will help us design a full-scale RCT with a precise estimate of the sample size and dosage of TC needed for reducing knee OA pain in community-dwelling elders with mild CI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Dementia
Keywords
osteoarthritis, knee, Cognitive impairment, Tai Chi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Title
Attentation control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
The experimental group received three sessions of Sun Tai Chi (TC) a week for 20 weeks (20-to-40 minute exercise plus a 5-minute rest per session). Sun TC includes 6 basic and 6 advanced forms designed for all ages with arthritis seeking a joint-safe exercise routine.
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Intervention Description
The attention control group participated in health education, culture related activities and other activities for a total of 20 weeks. The attention control protocol was standardized in terms of teaching content, materials and duration. The length and frequency of the activities carried out in this group closely matched those in the TC group.
Primary Outcome Measure Information:
Title
Change from baseline in pain at Week 5
Description
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Time Frame
Week 5
Title
Change from baseline in pain at Week 9
Description
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Time Frame
Week 9
Title
Change from baseline in pain at Week 13
Description
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Time Frame
Week 13
Title
Change from baseline in pain at Week 17
Description
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Time Frame
Week 17
Title
Change from baseline in pain at Week 21
Description
Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Time Frame
Week 21
Secondary Outcome Measure Information:
Title
Physical function
Description
Measured by 1). WOMAC Physical Function subscale; and 2). Get Up and Go (GUG)
Time Frame
Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points
Title
Cognitive function
Description
Mini Mental Status Exam (MMSE)
Time Frame
Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points
Title
Stiffness
Description
WOMAC Stiffness subscale
Time Frame
Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points
Title
Quadriceps strength
Description
Measured by the Sit-To-Stand (STS)
Time Frame
Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points
Title
Pain level (each session)
Description
Measured by the Verbal Descriptor Scale (VDS)
Time Frame
Participants will be followed for the duration of intervention period (20 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 years or order;
A MMSE score of 18-28;
Diagnosis of knee OA based on medical history reviewed with elders or family members/staff and confirmation from the physician/APN;
Self-report of knee OA pain ≥ 2 on the VDS, or pain score ≥ 3 on the WOMAC pain subscale;
Ability to speak English;
Physician's/APN's permission to participate;
No regular exercise program in the past month;
Ambulation without assistance from staff or a walking device for 50 meters; and
Ability to stand and maintain balance for 1 minute without a walking device
Exclusion Criteria:
Uncorrectable moderate or severe hearing or vision deficits;
Parkinson's disease;
Cancer pain;
Chronic pain conditions, such as rheumatoid arthritis, fibromyalgia, or severe low back pain;
Diabetic neuropathy;
Arthroscopic surgery or total knee- or hip-replacement surgery in the past 6 months;
Fractures in the past 6 months;
Major psychiatric disorder or positive screen for depressive symptoms (GDS-15 score ≥ 5) without taking medication;
History of falls in the past 3 months; or
Vertigo in the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pao-Feng Tsai, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical asciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20077977
Citation
Tsai PF, Chang JY, Chowdhury N, Beck C, Roberson PK, Rosengren K. Enrolling older adults with cognitive impairment in research: lessons from a study of Tai Chi for osteoarthritis knee pain. Res Gerontol Nurs. 2009 Oct;2(4):228-34. doi: 10.3928/19404921-20090731-03. Epub 2009 Oct 27.
Results Reference
background
PubMed Identifier
26275650
Citation
Tsai PF, Chang JY, Beck C, Kuo YF, Keefe FJ, Rosengren K. A supplemental report to a randomized cluster trial of a 20-week Sun-style Tai Chi for osteoarthritic knee pain in elders with cognitive impairment. Complement Ther Med. 2015 Aug;23(4):570-6. doi: 10.1016/j.ctim.2015.06.001. Epub 2015 Jun 9.
Results Reference
derived
PubMed Identifier
23017610
Citation
Tsai PF, Chang JY, Beck C, Kuo YF, Keefe FJ. A pilot cluster-randomized trial of a 20-week Tai Chi program in elders with cognitive impairment and osteoarthritic knee: effects on pain and other health outcomes. J Pain Symptom Manage. 2013 Apr;45(4):660-9. doi: 10.1016/j.jpainsymman.2012.04.009. Epub 2012 Sep 24.
Results Reference
derived
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Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia
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