Effect of Prehabilitation Before Total Knee Replacement on Post-operative Patient-reported Joint Awareness, Enablement and Knee Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery
研究概览
简要总结
The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.
The main questions it aims to answer are:
- Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
- Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
- Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?
Participants will be randomized stratified by age (≤ 67 years, > 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible.
详细描述
Eligible patients will be randomized through opaque concealed envelopes stratified by age (≤ 67 years, > 67 years) with a 1:1 allocation ratio into the intervention or the control group, after getting a decision for surgery from the surgeon. Inclusion and exclusion criteria are described in a section below. The envelopes and allocation list will be kept in a locked fire-proof storage in a different building than where the allocation process will take place.
The patients in the intervention group will participate in pre-operative supervised exercise therapy and education, continuously ongoing from point of surgery decision until surgery. Twice a week, approximately one hour/session. Training consists of individualized strength, balance and mobility exercises, and education consists of ongoing individualized discussion regarding patients' expectations of post-operative recovery, pain and swelling, course of rehabilitation, long term function and activity level etc.
Patients in both groups will participate in a standardized pre-operative information session, approximately 2 weeks before surgery. General information regarding preparations before surgery (e.g. preparing the home environment), events during the hospital stay and the rehabilitation process after discharge will be provided as part of the standard care procedure.
Patients in the control group will participate in the standardized pre-operative information session mentioned above. They will not receive any specific information regarding training and exercise or individualized education outside of regular discussion with the surgeon when consenting to/making the decision for surgery.
Baseline and follow-up measures after 8 weeks, 1-2 weeks before surgery and 6 weeks after surgery will include objective and patient reported outcome measures. Follow-up measures 3 months and 1 year after surgery will consist of patient reported outcome measures only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor blinded to group allocation
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waiting list for primary unilateral knee replacement surgery
- •Osteoarthritis of the knee being the primary reason for surgery
- •Reside within 60 minutes of travel to the site of the intervention
排除标准
- •Previous knee replacement surgery in the other knee
- •Other reason than osteoarthritis of the knee as the primary reason for surgery
- •Impaired cognitive function
- •Not being independent speaking and reading in swedish language
- •Chronic illness or disability etc hindering full participation in the intervention
研究组 & 干预措施
Intervention group
Pre-operative exercise therapy and education before knee replacement surgery
干预措施: Pre-operative exercise therapy and education (Other)
Intervention group
Pre-operative exercise therapy and education before knee replacement surgery
干预措施: Standardized pre-operative information session (Other)
Control group
Standard care
干预措施: Standardized pre-operative information session (Other)
结局指标
主要结局
Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery
时间窗: Baseline; 1 year after surgery
Patient-reported outcome measure (PROM) where patients assesses how aware they are of their affected knee on a 5 item Likert scale in 12 different situations in daily living. The result is summarized into a total result on a 0-100 scale, with 0 being worst (high awareness) and 100 being best (low awareness)
Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery
时间窗: Baseline; 6 weeks after surgery
6-item PROM where patients are asked to assess their ability to cope with life, understand and cope with their disease, ability to stay healthy and help themselves etc during the last 4 weeks. Items are answered in a 5-item Likert scale ranging from extremely well to not at all. Results are summarized into a total score from 6 to 30, with higher scores indicating better enablement.
次要结局
- Patient satisfaction at 1 year after surgery(1 year after surgery)
- Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery)
- Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery)
- Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery)
- Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery)
- Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery(Baseline; 6 weeks after surgery)
- Change in active knee range of motion from baseline to 6 weeks after surgery(Baseline; 6 weeks after surgery)
- Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery(Baseline; 6 weeks after surgery)
- : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery)
- Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery; 1 year after surgery)
- Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 3 months after surgery; 1 year after surgery)
- Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery(Baseline; 8 weeks after randomization/start of intervention; 1-2 weeks before surgery; 6 weeks after surgery; 3 months after surgery)
- Change in objectively measured physical activity and sedentary habits via accelerometer, from baseline to 8 weeks after start of intervention, 3 months and 1 year after surgery(Baseline; 8 weeks after randomization/start of intervention; 3 months after surgery; 1 year after surgery)
研究者
Joanna Kvist
Professor
Linkoeping University