- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204213
The 8 Section Brocade Tai Chi Therapy for Knee Osteoarthritis
December 17, 2019 updated by: Dr. Ho Ki Wai, Chinese University of Hong Kong
The 8 Section Brocade Tai Chi Therapy in Disease Management Program for Advanced Knee Osteoarthritis Patients: A Community - Based Care Approach
Tai Chi exercises have increasingly grown in popularity among older adults in the past decades.
It has been well studied to its efficacies in proportion with the management of elderly fall prevention and mineral-structured bone density enhancement.
Nevertheless, existing study sources do little exemplified a quantifiable measures of effects in patients suffer from osteoarthritis of knees being impacted from a routine performance of Tai Chi.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
112 patients with end stage osteoarthritis knee had enrolled into a customised multidisciplinary education program that consisted of one hour healthcare education seminars followed by another hour of 8 Section Brocade (Baduanjin) sitting Tai Chi classes for 4 consecutive weeks.
Followup measures were taken at baseline, 3 and 6 months post course commencement using the International Physical Activity Questionnaire (IPAQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36v2 Health Survey and the Client Satisfaction Questionnaire (CSQ-8).
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Department of Orthopaedics & Traumatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Population with knee osteoarthritis.
Description
Inclusion Criteria:
- Diagnosed in symptomatic knee OA of Kellgren Lawrence (KL) grade 3 or 4, and have elected on list waiting for lower limb arthroplasty surgery
- Aged 55 or above
- Able to ambulate independently
Able to communicate in Cantonese
Exclusion Criteria:
- Previously underwent total knee replacement surgery
- Diagnosed with other non-OA arthritide forms of the knees
- Unable to complete all four sessions
- Unable to complete all time-point measurements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
8 Section Brocade Tai Chi Therapy
Subject participants with end stage osteoarthritis knee were enrolled into a customised multidisciplinary education program that consisted of one hour healthcare education seminars followed by another hour of 8 Section Brocade (Baduanjin) sitting Tai Chi classes for 4 consecutive weeks.
|
8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total physical activity metabolic equivalent of task (MET)-minutes per week
Time Frame: 6 Months
|
The international Physical Activity Questionnaire-Short Form is designed to measure physical activity, and standardize measures of health-related physical activity behavior through 8 questions and divide patients into 3 activity groups.
The health-enhancing physical activity level of category is for those people who either engaged in (1) ≥ 1500 MET-minutes on vigorous-intensity activity for at least three days, OR (2) at a combination of walking, moderate to vigorous intensity activities accumulative performance to ≥ 3000 MET-minutes per week.
The Minimally Active level category is considered at the enrollment of (3) ≥ 20 mins vigorous activity for at least three days, OR (4) moderate-intensity activity or walking for ≥ 30 mins for at least five days, OR (5) any combination of walking, moderate/vigorous-intensity activities for at least 600 MET-minutes per week.
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms and Physical Functional Disability Scores
Time Frame: 6 Months
|
The secondary outcome was shown by the symptoms and physical functional disability scores represented by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the quality of life of participants represented by the self-rated questionnaire SF-36v2.
WOMAC is a widely used standardized questionnaire to evaluate the condition of patients with osteoarthritis of the knee and hip, in three different domains for pain (score range 0 to 20), stiffness (0 to 8) and physical function (0 to 68).
|
6 Months
|
|
Client Satisfactory Questionnaires Scores
Time Frame: 6 Months
|
The Client Satisfactory Questionnaires (CSQ-8) is to assess the effectiveness of the customised programme and to collect feedback from a patient's point of view.
Calculation on the 90 CSQ8 sampling sizes were made with the consideration on 95% confidence level, set with a 5% margin of error for the estimated confidence interval of 10.
The CSQ-8 is a questionnaire that measures client satisfaction with services summing the individual item scores to produce a range of 8-32, with high scores indicating a greater satisfaction.
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2015
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
December 15, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 18, 2019
Study Record Updates
Last Update Posted (Actual)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 17, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3505.2715
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
Clinical Trials on Tai Chi Exercise
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...Not yet recruiting
-
Universidade Estadual Paulista Júlio de Mesquita...Fundação de Amparo à Pesquisa do Estado de São PauloNot yet recruiting
-
Anhui Medical UniversityCompletedRandomized Clinical Trial | Intestinal Flora | Exercise Intervention | Tai Chi ChuanChina
-
China Medical University HospitalRecruiting
-
Chungnam National UniversityNational Research Foundation of KoreaRecruiting
-
Texas Tech University Health Sciences CenterCompletedKnee Osteoarthritis | Mind-body ExerciseUnited States
-
The University of Hong KongCompleted
-
University of Massachusetts, BostonNational Institute on Aging (NIA)Completed
-
University of California, Los AngelesCompleted