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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Diagnosed in symptomatic knee OA of Kellgren Lawrence (KL) grade 3 or 4, and have elected on list waiting for lower limb arthroplasty surgery
  2. Aged 55 or above
  3. Able to ambulate independently

  4. Able to communicate in Cantonese

    Exclusion Criteria:

  5. Previously underwent total knee replacement surgery
  6. Diagnosed with other non-OA arthritide forms of the knees
  7. Unable to complete all four sessions
  8. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Tai Chi Exercise
8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings