NCT01528566

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

January 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

January 24, 2012

Last Update Submit

February 3, 2012

Conditions

Osteoarthritis, KneeDementia

Keywords

osteoarthritis, kneeCognitive impairmentTai Chi

Outcome Measures

Primary Outcomes (5)

  • 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.

    Week 5

  • 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.

    Week 9

  • 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.

    Week 13

  • 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.

    Week 17

  • 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.

    Week 21

Secondary Outcomes (5)

  • Physical function

    Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points

  • Cognitive function

    Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points

  • Stiffness

    Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points

  • Quadriceps strength

    Week 1 (baseline), week 5, week 9, week 13, week 17 and week 21 (post-test) for a total of 6 time points

  • Pain level (each session)

    Participants will be followed for the duration of intervention period (20 weeks)

Study Arms (2)

Tai Chi

EXPERIMENTAL
Behavioral: Tai Chi

Attentation control

PLACEBO COMPARATOR
Behavioral: Attention control

Interventions

Tai ChiBEHAVIORAL

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.

Tai Chi
Attention controlBEHAVIORAL

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.

Attentation control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical asciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (3)

  • 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.

    PMID: 20077977BACKGROUND

  • 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.

    PMID: 26275650DERIVED

  • 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.

    PMID: 23017610DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeDementiaCognitive Dysfunction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Pao-Feng Tsai, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 8, 2012

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

US(1)