Pacheco-Brousseau Lissa, Dobransky Johanna, Jane Alanna, Beaulé Paul E, Poitras Stéphane
Faculty of Health Sciences, School of Rehabilitation Sciences, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.
Pilot Feasibility Stud. 2022 Jul 30;8(1):162. doi: 10.1186/s40814-022-01126-9.
There are conflicting results on the effect of preoperative exercise programs on long-term function and little evidence on short-term function. The aim is to assess the feasibility of a preoperative strengthening exercise program in patients undergoing hip or knee joint arthroplasty in terms of trial design, recruitment, and follow-up rates.
A randomized controlled feasibility study with patients undergoing hip or knee joint arthroplasty. Patients were randomized to a preoperative strengthening exercise program or standard of care. Feasibility outcome measures were recruitment rate (≥ 50%) and loss to follow-up (≤ 15%).
Of the 129 eligible participants, 63 participants consented to participate in the study (49%), and 27 were successfully randomized prior to surgery (43%). All 27 participants completed the baseline assessment. Of these, 6 (22%) had surgery during the exercise period. Of the remaining 21 participants, 20 (95%) completed the pre-surgery assessment. The study was terminated before five participants could be eligible for the 6-month assessment. Sixteen (76%) participants completed the 6-week post-surgery assessment. Twelve participants completed the 6-month assessment (75%).
Given the recruitment rate, randomization barriers, and study participant loss to follow-up, the study was discontinued since it was not considered feasible in this current form at our clinical site despite modifications made to the protocol. Future investigations into a modified intervention via telerehabilitation should be explored.
ClinicalTrials.gov, NCT03483519 . Retrospectively registered in March 2018.
术前锻炼计划对长期功能的影响存在相互矛盾的结果，而关于短期功能的证据较少。目的是从试验设计、招募和随访率方面评估术前强化锻炼计划在接受髋关节或膝关节置换术患者中的可行性。
对接受髋关节或膝关节置换术的患者进行一项随机对照可行性研究。患者被随机分为术前强化锻炼计划组或常规治疗组。可行性结局指标为招募率（≥50%）和失访率（≤15%）。
在129名符合条件的参与者中，63名参与者同意参加研究（49%），27名在手术前成功随机分组（43%）。所有27名参与者均完成了基线评估。其中，6名（22%）在锻炼期间接受了手术。在其余21名参与者中，20名（95%）完成了术前评估。在5名参与者有资格进行6个月评估之前，该研究终止。16名（76%）参与者完成了术后6周评估。12名参与者完成了6个月评估（75%）。
鉴于招募率、随机分组障碍和研究参与者失访情况，尽管对方案进行了修改，但由于在我们的临床场所该研究以当前形式被认为不可行，因此研究停止。未来应探索通过远程康复进行改良干预的研究。
ClinicalTrials.gov，NCT03483519。2018年3月进行回顾性注册。
