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Not Yet Recruiting NCT05668312

Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement

Conditions: Knee Osteoarthritis

Sex: Male
Ages: 65 Years – 80 Years
Phase: NA
Enrollment: 58
Sponsor: Istituto Ortopedico Galeazzi

Summary

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.

Eligibility Criteria

Inclusion Criteria 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:Male sex of any ethnicity;Age between 18 and 30 years;Scheduled Anterior Cruciate Ligament reconstruction surgery;Body Mass Index ≤ 30.Exclusion Criteria 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05668312). StuddyBuddy aggregates publicly available trial information.