Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Rate of recruitment and rate of retention |
The recruitment and attrition rates will be monitored on a monthly basis to determine the presence of any specific trends. The recruitment rate (all potential participants), retention and attrition rates (all randomized participants) and completion rates (all enrolled participants) will be assessed at the end of study. Reasons for ineligibility, and/or non-recruitment of eligible patients will be recorded and grouped into categories. |
After 52 week post-TKA follow-up |
|
Primary |
Facilitators and barriers of the intervention |
Attendance and exercise logbooks will be used to monitor non-adherence. The instructor will communicate with non-adherent participants to understand the reasons and barriers for non-adherence and to develop appropriate strategies to improve adherence. Furthermore, to assess the acceptability of the intervention, each participant in the intervention group will be invited to participate in a face-to-face or video call interviews semi-structured interview based on participants' preferences within 1 month after the final follow-up. |
During the intervention and after 52 week post-TKA follow-up |
|
Primary |
Sample size estimation for the future definitive trial |
Based on the standard deviation (SD) of The Chinese version of the Knee Injury and Osteoarthritis Outcome Scale (the higher the score, the better the performance )so as to inform the sample size calculation for the effectiveness trial. |
After 52 week post-TKA follow-up |
|
Primary |
Self-reported physical function |
The Chinese version of Knee Injury and Osteoarthritis Outcome Scale will be used to document self-reported physical function and to evaluate knee status before/after TKA |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Primary |
Number of trips/falls |
The number of trips, falls and fall-related injuries in the 12 months before baseline will be documented. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Objective measures of static and dynamic stability |
When wearing the sensors, participants will perform a tandem stance test with eyes open and eyes closed, the TUG and the 6MWT. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Knee pain |
It will be measured by an 11-point numeric pain rating scale, which ranges from 0 (no pain) to 10 (the worst imaginable pain). It documents the current, best, and worst pain in the last 24 hours. It will be used to record the pain intensity of participant's knee and other body parts, if appropriate. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Depression |
Depressive symptoms will be examined by the short form Chinese version of the Geriatric Depression Scale, which comprises 15 questions. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Physical activity level |
Physical activity will be assessed by the Physical Activity Scale for the Elderly (Chinese version), which is a 12-item questionnaire that documents leisure, physical, household and work-related activities over the last 7 days. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Fear of falling |
Concern of falling will be measured with the Falls Efficacy Scale, which showed good reliability and validity in measuring fear of falling in frail older people. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Global impression of change |
Symptom severity, treatment response and the efficacy of treatment 24-weeks post-TKA will be measured by the Global Impression of change scale. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Joint range of motion |
The ranges of motion of hip, knee, and ankle joints will be evaluated using a goniometer. These assessments are chosen because limited knee/ankle joint ranges have been reported as potential risk factors for falls. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Balance assessment |
The Brief-Balance Evaluation Systems test comprises six static and six dynamic tasks of different difficulty levels. |
1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups |
|
Secondary |
Remote monitoring of physical activity |
Participants' physical activity will be measured by a wearable sensor. accelerometer. The participant will wear ActiGraph on the right hip, near the iliac crest for 7 days except during sleeping, showering or bathing. Data from the vertical axis will be recorded in 15s epochs and be initialized using the normal filter. The data be classified into different activity levels by ActiLife V6.11.0: sedentary (0-99 counts/minute), light (100-2019 counts/minute), moderate (2020-5998 counts/minute), and vigorous (> 5999 counts/minute). |
over 7 days at 1 week before TKA, 7 days during the 12th , 24th and 52th week after |
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