Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• Both sexes of any ethnicity;

• Age between 18 and 35 years;

• Scheduled Anterior Cruciate Ligament reconstruction surgery;

• Body Mass Index ≤ 30.

Locations
Other Locations
Italy
IRCCS Istituto Clinico San Siro
NOT_YET_RECRUITING
Milan
IRCCS Ospedale Galeazzi - Sant'Ambrogio (Coordinator)
RECRUITING
Milan
Contact Information
Primary
Stefania Guida
stefania.guida@grupposandonato.it
3471606501
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-05-10
Participants
Target number of participants: 68
Treatments
Experimental: TELE-pre group
Subjects in the TELE-prehabilitation group receive remote prehabilitation using advanced technologies.
Active_comparator: Control group
The control group is composed by the Con-O (Control Older) group and the Con-Y (Control Young) group. In the Con-O group (n=24) subjects receive home-based prehabilitation using a printed booklet; in the Con-Y group (n=20) subjects do not receive any prehabilitation program.~Subjects in the Con-Y group will be recruited from patients waiting for anterior cruciate ligament reconstruction, thus they will be only assessed with muscular biopsy and blood sampling.
Sponsors
Leads: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov