Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6/7 weeks
研究概览
简要总结
After knee arthroplasty rehabilitation is fundamental to patient's functional recovery, but in recent years there has been a growing interest in the possibility to prepare patients for surgery through a "prehabilitation" program. This two-parallel groups randomized clinical trial aims at evaluating the effects of a preoperative rehabilitation programme carried out at patient's home using advanced technologies, on subjects waiting for knee replacement. In particular, the primary objective of this study is to assess the superiority of a tele-prehabilitation programme compared to standard prehabilitation (remotely delivered with a booklet) in determining an improvement in lower limb function, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire, at the end of the programme. This study also aims at assessing possible differences between groups in muscle function, pain, autonomy in the activity of daily living, adherence to treatment and patients' satisfaction with the prehabilitation modality. Through the analysis of quadriceps muscle and blood samples, we will also evaluate possible changes in the expression of specific markers that the prehabilitation programme may be able to determine at muscle level. Both the intervention and the control groups will perform a prehabilitation program in the 6 weeks just before surgery. The program will include therapeutic exercises and educational contents. Subjects in the tele-prehabilitation group will receive a tablet with two accelerometers and a balance board for the remote execution of the program, while the control group will receive the same intervention through a booklet. Subjects recruited will be assessed at 5 timepoints: before starting the prehabilitation program, the day of surgery, 7± 2 and 15 ± 2 days after surgery, 3 months ± 7 days after surgery.
详细描述
Based on the existing literature, we expected to observe an effect size of 0.8 in WOMAC (primary outcome) between groups at the end of the tele-prehabilitation program. Therefore, considering a test power of 80% and an alpha error of 5%, we have computed a sample size of 48 subjects, 24 for each group (taking into account a possible drop-out rate of 15-20%).
Twenty healthy young subjects (10 males and 10 females) will be also recruited only for muscle and blood samples collection, that will be used as benchmarks for the intervention and control groups analyses (they will no undergo any prehabilitation program).
The recruited subjects will be randomly allocated (with a 1:1 ratio randomization list) in the tele-prehabilitation or in the control groups. During the 6 weeks just before surgery, both groups will perform 5 sessions a week of the same home-based prehabilitation program. Each session is planned as follow: 5 minutes of warm-up, 30 minutes of work (mobility, strengthening and balance exercises) and 5 minutes of cool-down.
In details, for each session subjects will perform the following exercises:
- Warm-up (about 5 minutes)
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for TELE-pre and Con-O groups (also previous information are valid only for these groups):
- •Scheduled unilateral total knee replacement surgery according to Fast-Track pathway;
- •Preoperative criteria for home discharge;
- •At least one person cohabitant;
- •Familiarity with tablet/computer use and Internet access;
- •Informed consent signature.
- •Inclusion Criteria for Con-Y group:
- •Both sexes of any ethnicity;
- •Age between 18 and 35 years;
- •Scheduled Anterior Cruciate Ligament reconstruction surgery;
- •Body Mass Index ≤ 30.
排除标准
- •for TELE-pre and Con-O groups:
- •Scheduled surgery for knee revision arthroplasty;
- •Lower limbs surgery in the previous 6 months;
- •Lower limbs fractures in the previous 6 months;
- •Congenital or post-traumatic knee morphologic alterations;
- •Rehabilitation treatments in the previous 6 months focused on the interested knee functional recovery;
- •Ongoing neurological or oncological diseases;
- •HIV, HCV, HBV, TPHA infection;
- •Cognitive impairment;
- •Known local anaesthetics allergic reactions;
- •Ongoing non-suspendable anticoagulant therapies;
- •Known muscular diseases.
- •Exclusion Criteria for Con-Y group:
- •Body Mass Index > 30;
- •Ongoing oncological diseases;
- •Sampling area infection;
- •HIV, HCV, HBV, TPHA infection;
- •Known neuromuscular/muscular diseases;
- •Ongoing non-suspendable anticoagulant therapies,
- •Female subjects in pregnancy status or breastfeeding.
结局指标
主要结局
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6/7 weeks
时间窗: The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1).
The WOMAC questionnaire is a self-administrated health status measure for pain, stiffness and function assessment in patients with hip or knee osteoarthritis. It is composed by 24 items and uses a 5-point Likert scale (from 0 to 4).
次要结局
- Sit-to-stand test(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Knee extensor and flexors maximal strength assessment(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Timed Up-and-Go test(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Oxford Knee Score (OKS)(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Numeric Pain Rating Scale (NPRS)(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Short Form-12(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- International Physical Activity Questionnaire (IPAQ)(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Satisfaction interview(6/7 weeks after T0.)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Knee Range Of Motion(The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4))
- Muscle metabolism markers(The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4))
- Prehabilitation diary(6/7 weeks after T0.)
- Blood biomarkers(The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4))