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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04204213
Other study ID # 3505.2715
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2015
Est. completion date December 31, 2016

Study information

Verified date December 2019
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 31, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Tai Chi Exercise
8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars

Locations

Country Name City State
Hong Kong Department of Orthopaedics & Traumatology Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Months
Secondary 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). 6 Months
Secondary 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. 6 Months
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