Osteoarthritis, KneeNCT04204213
The 8 Section Brocade Tai Chi Therapy for Knee Osteoarthritis
An observational study of Osteoarthritis, Knee and Tai Chi, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Tai Chi, Exercise Training
- What is being tested?
- Tai Chi Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2015to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with knee osteoarthritis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoarthritis, Knee, Tai Chi, Exercise Training
- Being tested
- Tai Chi Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tai Chi Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physical activity metabolic equivalent of task (MET)-minutes per week
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.
Measured: 6 Months
Secondary outcomes (2)
Symptoms and Physical Functional Disability Scores
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).
Measured: 6 Months
Client Satisfactory Questionnaires Scores
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start31 Jan 2015
- Primary completion30 Jun 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204213
- Sponsor's protocol ID
- 3505.2715
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ho KK, Pong G, Poon QW, Kwok JY, Chau WW, Ong MT. A community-centric multi-disciplinary education program with the 8-section brocade Tai Chi therapy for patients with osteoarthritis of the knee - a pilot study. BMC Complement Med Ther. 2021 Dec 14;21(1):297. doi: 10.1186/s12906-021-03480-2.
PubMed 34906130
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 8 Section Brocade Tai Chi Therapy in Disease Management Program for Advanced Knee Osteoarthritis Patients: A Community - Based Care Approach
- ClinicalTrials.gov ID
- NCT04204213
- Acronym / sponsor ID
- 3505.2715
- Conditions
- Osteoarthritis, Knee, Tai Chi, Exercise Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8 Section Brocade Tai Chi Therapy | – | Behavioral: Tai Chi ExerciseSubject 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with knee osteoarthritis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi Exercise8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars | Behavioural | 8 Section Brocade Tai Chi Therapy |
Primary outcome
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.
2 secondary outcomes
Symptoms and Physical Functional Disability Scores
Time frame: 6 Months
Client Satisfactory Questionnaires Scores
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Derived from this study: PubMed 34906130Ho KK, Pong G, Poon QW, Kwok JY, Chau WW, Ong MT. A community-centric multi-disciplinary education program with the 8-section brocade Tai Chi therapy for patients with osteoarthritis of the knee - a pilot study. BMC Complement Med Ther. 2021 Dec 14;21(1):297. doi: 10.1186/s12906-021-03480-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Tai Chi, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total physical activity metabolic equivalent of task (MET)-minutes per week (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.