Tele-prehabilitation for patients awaiting knee replacement
Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial
This study tests if a home-based exercise program using technology can help people waiting for knee replacement surgery recover better than those following regular pre-surgery exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Trial ID | NCT05668312 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a tele-prehabilitation program for patients scheduled for knee replacement surgery. Participants will be randomly assigned to either a tele-prehabilitation group, which utilizes advanced technologies for home-based rehabilitation, or a control group that follows standard prehabilitation methods. Over six weeks, both groups will engage in a structured exercise regimen designed to improve lower limb function, muscle strength, and overall recovery outcomes. The primary measure of success will be the improvement in function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for unilateral total knee replacement surgery who have access to technology and can perform exercises at home.
Not a fit: Patients who have had recent lower limb surgeries or those with ongoing neurological or oncological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and functional outcomes for patients undergoing knee replacement surgery.
How similar studies have performed: Previous studies have shown promising results with tele-rehabilitation approaches, suggesting potential success for this novel application in knee prehabilitation.
Eligibility criteria
Show full inclusion / exclusion 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: * Both sexes of any ethnicity; * Age between 18 and 35 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, * Female subjects in pregnancy status or breastfeeding.
Where this trial is running
Milan and 1 other locations
- IRCCS Istituto Clinico San Siro — Milan, Italy (Not_yet_recruiting)
- IRCCS Ospedale Galeazzi - Sant'Ambrogio (Coordinator) — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Laura Mangiavini — IRCCS Galeazzi - Sant'Ambrogio Hospital
- Study coordinator: Stefania Guida
- Email: stefania.guida@grupposandonato.it
- Phone: 3471606501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.