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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
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Dementia
Behavioral: Tai Chi
Behavioral: Attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tai Chi on Osteoarthritic Knee Pain in Elders With Mild Dementia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 55
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi 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.
Placebo Comparator: Attentation control 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.

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:

  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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528566

Locations
United States, Arkansas
University of Arkansas for Medical asciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Pao-Feng Tsai, PhD University of Arkansas
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01528566     History of Changes
Other Study ID Numbers: R21NR01003
Study First Received: January 24, 2012
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Arkansas:
osteoarthritis, knee
Cognitive impairment
Tai Chi

Additional relevant MeSH terms:
Dementia
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Joint Diseases
Mental Disorders
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014