NCT05668312

Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement

Status unknown NA Last updated 12 January 2024

What this trial tests

NA trial testing Tele-prehabilitation in Knee Osteoarthritis in 68 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
10 February 2025

10 May 2025

Quick facts

Lead sponsor	I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	68
Start date	1 January 2023
Primary completion	10 February 2025
Estimated completion	10 May 2025
Sites	2 locations across Italy

Drugs / interventions tested

• Tele-prehabilitation
• Standard prehabilitation

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — full company profile →

Who can join

Adults 65 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial.
   Guida S, Vitale J, Gianola S, Castellini G, et al · · 2023 · cited 2× · PMID 37793919 · DOI 10.1136/bmjopen-2023-073163