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Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01528566
First received: January 24, 2012
Last updated: February 3, 2012
Last verified: February 2012

January 24, 2012
February 3, 2012
January 2008
June 2010   (final data collection date for primary outcome measure)
  • Change from baseline in pain at Week 5 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 17 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
    Measured by 1). the WOMAC pain subscale; 2). the Verbal Descriptor Scale (VDS); 3). Keefe observational method; and 4). Analgesic intake.
Same as current
Complete list of historical versions of study NCT01528566 on ClinicalTrials.gov Archive Site
  • Physical function [ 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 ] [ Designated as safety issue: No ]
    Measured by 1). WOMAC Physical Function subscale; and 2). Get Up and Go (GUG)
  • Cognitive function [ 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 ] [ Designated as safety issue: No ]
    Mini Mental Status Exam (MMSE)
  • Stiffness [ 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 ] [ Designated as safety issue: No ]
    WOMAC Stiffness subscale
  • Quadriceps strength [ 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 ] [ Designated as safety issue: No ]
    Measured by the Sit-To-Stand (STS)
  • Pain level (each session) [ Time Frame: Participants will be followed for the duration of intervention period (20 weeks) ] [ Designated as safety issue: No ]
    Measured by the Verbal Descriptor Scale (VDS)
Same as current
Not Provided
Not Provided
 
Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia
Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia

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.

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:

  1. To test the efficacy of a modified TC program in reducing knee OA pain in community-dwelling elders with mild CI.
  2. To test the efficacy of a modified TC program in improving physical function and quadriceps strength.
  3. To investigate feasibility and compliance issues in conducting TC.
  4. 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Knee
  • Dementia
  • Behavioral: Tai Chi
    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.
  • Behavioral: Attention control
    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.
  • Experimental: Tai Chi
    Intervention: Behavioral: Tai Chi
  • Placebo Comparator: Attentation control
    Intervention: Behavioral: Attention control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 60 years or order;
  2. A MMSE score of 18-28;
  3. Diagnosis of knee OA based on medical history reviewed with elders or family members/staff and confirmation from the physician/APN;
  4. Self-report of knee OA pain ≥ 2 on the VDS, or pain score ≥ 3 on the WOMAC pain subscale;
  5. Ability to speak English;
  6. Physician's/APN's permission to participate;
  7. No regular exercise program in the past month;
  8. Ambulation without assistance from staff or a walking device for 50 meters; and
  9. Ability to stand and maintain balance for 1 minute without a walking device

Exclusion Criteria:

  1. Uncorrectable moderate or severe hearing or vision deficits;
  2. Parkinson's disease;
  3. Cancer pain;
  4. Chronic pain conditions, such as rheumatoid arthritis, fibromyalgia, or severe low back pain;
  5. Diabetic neuropathy;
  6. Arthroscopic surgery or total knee- or hip-replacement surgery in the past 6 months;
  7. Fractures in the past 6 months;
  8. Major psychiatric disorder or positive screen for depressive symptoms (GDS-15 score ≥ 5) without taking medication;
  9. History of falls in the past 3 months; or
  10. Vertigo in the past month
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01528566
R21NR01003
No
University of Arkansas
University of Arkansas
National Institute of Nursing Research (NINR)
Principal Investigator: Pao-Feng Tsai, PhD University of Arkansas
University of Arkansas
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP