Physical Rehabilitation Versus no Physical Rehabilitation After Total Hip and Knee Arthroplasties: Protocol for a Pragmatic, Randomized, Controlled, Replication Trial (DRAW2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Function in daily living (ADL).
研究概览
简要总结
Overall frame: The overall or "parent" DRAW-project is a large-scale project run in Denmark that aims to provide substantial level 1A evidence-data related to the question: Does rehabilitation after total hip and knee replacements work? In the DRAW project, the authors challenge the belief that physical rehabilitation is clinically important - and surely better than "no physical rehabilitation". To challenge this belief thoroughly, the DRAW project holds many individual work packages centered around the same question. These work packages will be conducted in collaboration with municipality rehabilitation centers in Denmark so that specific usual care strategies are reflected in the different trials and local clinical relevance is as well as implementation potential are increased.
详细描述
The DRAW2-trial is a pragmatic, randomised controlled trial that aims to replicate the DRAW1-trial findings (clinicaltrials.gov: NCT03750448, trial protocol: https://f1000research.com/articles/10-146). Based on stakeholder input from Municipality Rehabilitation Bornholm, the DRAW1-trial was designed as a superiority trial to test the hypothesis that physical rehabilitation (telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation in a mixed population of patients after total hip and knee arthroplasty (THA and TKA, respectively). After DRAW1-trial inclusion was completed and the target sample size reached, an opportunity to continue the trial presented because additional funding was obtained. At the same time, Municipality Rehabilitation Bornholm asked for stratified data (THA/TKA) that could help guide their decision concerning a potential purchase of telerehabilitation equipment (more details on stakeholder input can be found in the trial protocol, https://f1000research.com/articles/10-146). To meet this new research objective of stratified analysis for THA and TKA, it was advised from the local ethical committee that a new and almost identical trial was registered, which would allow for a doubling of the sample simple size, so that adequately powered stratified analyses could be made. This new trial is named the DRAW2-trial.
The DRAW2-trial will adhere to the published DRAW1-trial protocol (https://f1000research.com/articles/10-146) and only small logistic modifications to trial procedures have been made. Because some of the DRAW1-trial participants felt overwhelmed by the amount of information they received during the first and only study introduction (usually takes place 5-7 days after surgery), the study introduction in the DRAW2-trial can be divided into two separate consultations a few days apart whenever deemed appropriate by the consulting physiotherapist. The DRAW2 trial will be reported and published independently, including the same outcomes and outcome hierarchy as the DRAW1-trial. As such, it will be an independent replication trial.
Research plan
While the DRAW2-trial will focus on replication of the DRAW-1 trial findings, the opportunity to run a replication trial at the same trial site with little delay between the two trials will also enable us to address the questions outlined below, by subsequent pooling of data from the two trials.
Question 1: Is physical rehabilitation superior to no physical rehabilitation after THA and TKA using two usual care strategies in Denmark (stratified analyses THA vs. TKA by pooling DRAW1 and 2 trial data)?
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)
盲法说明
A physiotherapist will assess the outcomes at baseline after which the patients are randomized. The same physiotherapist will then deliver the allocated intervention and no longer assess outcomes for this patient. A different physiotherapist, who is blinded to treatment allocation, will assess outcomes at the follow-up visits in this patient. At all follow-up visits, patients will be asked not to disclose any information regarding group allocation, and the physiotherapists will be instructed not to ask questions regarding group allocation.
The patients are blinded to the trial hypothesis in order to prevent ascertainment bias. The principal investigator is not an outcome assessor and will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having had primary, unilateral THA or TKA due to osteoarthritis. Patients being referred to receive postoperative rehabilitation at our institution.
- •Patients being able to speak, read and understand Danish language. Patients aged ≥ 18 years.
排除标准
- •Patients not able to comply with exercise instructions. Patients who are discharged to a nursing-home facility or receiving in-home rehabilitation by home care.
研究组 & 干预措施
Homebased telerehabilitation
Patients randomized to this group will receive interactive virtual rehabilitation using a mobile app. The telerehabilitation is based on sensor technology, developed by ICURA. This technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patient with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. This technology has already been successfully implemented in several different rehabilitation facilities across Denmark, and, hence, reflects current clinical practice.
干预措施: Homebased telerehabilitation (Procedure)
Homebased rehabilitation
This group will be instructed in similar exercises as patients allocated to telerehabilitation. However, this group will receive a written exercise-program with instructions to perform these exercises at home. The home-based exercise program will be created using exercise templates from Exorlive. Using a link provided in the exercise-program, the patients will be able to see short instruction-videos of the individual exercises.
干预措施: Homebased rehabilitation (Procedure)
No physical rehabilitation
This group of randomised patients will not be given any physical rehabilitation intervention. This means no physical activity or exercise designed and prescribed for restoring normal function or reducing pain cause by disease, injury or surgery. The no intervention group will be encouraged to stay active and continue life as usual, gradually returning to their activities of daily living when they feel ready for it.
干预措施: No physical rehabilitation (Procedure)
结局指标
主要结局
Function in daily living (ADL).
时间窗: Difference between groups at first follow up (6 weeks)
For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL). For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL). This subscale consists of 17 questions related to the patient's function in activities of daily living such as "descending stairs", "standing" and "getting in/out of car". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.
次要结局
- Function in daily living (ADL)(Difference between groups at 3 and 12 months follow up.)
- Symptoms, pain and quality of life.(Baseline, 6 weeks, 3 and 12 months.)
- Patient global assessment(Baseline, 6 weeks, 3 and 12 months.)
- 30-s chair stand test.(Baseline, follow up at 6 weeks, 3 and 12 months)
- 40 meters walking test.(Baseline, follow up at 6 weeks, 3 and 12 months)
- Use of analgesics(Baseline, follow up at 6 weeks, 3 and 12 months.)
- Patient satisfaction(Follow up at 6 weeks.)
- Time usage (care provider).(Baseline, follow up at 6 weeks, 3 and 12 months)
- Number of adverse events(Baseline, follow up at 6 weeks, 3 and 12 months)
研究者
Troels Mark Christensen
Principal investigator
Bornholms Regionskommune