Acceptability and Feasibility of a Community-based Strength, Balance and Tai Chi Rehabilitation Program in Improving Physical Function and Balance of Patients After Total Knee Arthroplasty: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Rate of recruitment and rate of retention
研究概览
简要总结
The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.
详细描述
This is a single-blinded 2-arm RCT. TKA participants will be randomized to either a 12-week community-based rehabilitation program starting at 12 weeks after TKA, or usual post-operative care without outpatient physiotherapy. A third group of asymptomatic controls will be recruited to provide comparisons at various time points. All post-TKA participants will undergo five clinical assessments: 1 week before TKA, and at 6, 12, 24 and 52 weeks after TKA. The untreated asymptomatic controls will be assessed at baseline, and 12 and 52 weeks from baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The reassessments at 6-, 12-, 24-, and 52 weeks, and prospective falls evaluation will be conducted by assessors blinded to group allocation. Due to the nature of the trial, the certified Tai Chi instructor who provides treatments and participants will not be blinded to group allocation.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years or above;
- •candidates for primary unilateral TKA who are placed on the TKA waiting list for less than 1 month before their surgery;
- •living independently in the community
排除标准
- •living in assisted living facilities, requiring nursing care, or planning to reside away from the hospital district within 1 year.
- •unstable medical conditions,
- •fracture of lower limbs,
- •malignancy in the last five years,
- •lower limb prosthesis/amputation,
- •congenital defect that is considered to cause the present complaint,
- •systemic inflammatory and autoimmune diseases,
- •previous osteotomy,
- •neurological diseases (e.g. Parkinson's disease, stroke),
- •blindness, revision TKA,
- •complications after primary TKA,
- •cognitive impairment with a Mini-Mental State Examination score < 19
- •prior experience in practicing Tai Chi exercise for at least 3 months
研究组 & 干预措施
Patients with intervention
12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA
干预措施: 12-week community-based multi-model Tai Chi rehabilitation program (Other)
Patients without intervention
usual post-operative care
干预措施: Usual post-operative care (Other)
Asymptomatic controls
untreated asymptomatic controls
干预措施: Untreated asymptomatic controls (Other)
结局指标
主要结局
Rate of recruitment and rate of retention
时间窗: After 52 week post-TKA follow-up
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.
Facilitators and barriers of the intervention
时间窗: During the intervention and after 52 week post-TKA follow-up
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.
Sample size estimation for the future definitive trial
时间窗: After 52 week post-TKA follow-up
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.
Self-reported physical function
时间窗: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
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
Number of trips/falls
时间窗: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
The number of trips, falls and fall-related injuries in the 12 months before baseline will be documented.
次要结局
- Joint range of motion(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Knee pain(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Depression(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Fear of falling(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Balance assessment(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Physical activity level(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Remote monitoring of physical activity(over 7 days at 1 week before TKA, 7 days during the 12th , 24th and 52th week after)
- Objective measures of static and dynamic stability(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)
- Global impression of change(1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups)