Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement

NCT05668312 | Unknown DMC

• 1 other identifier: Tele-prehabilitation
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Tele-prehabilitation; Prehabilitation; Virtual Reality; Advanced technologies; Knee osteoarthritis; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6/7 weeks

  The WOMAC questionnaire is a self-administrated health status measure for pain, stiffness and function assessment in patients with hip or knee osteoarthritis. It is composed by 24 items and uses a 5-point Likert scale (from 0 to 4).

  The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1).

Secondary Outcomes (13)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)

• Oxford Knee Score (OKS)

  The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)

• Numeric Pain Rating Scale (NPRS)

  The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)

• Short Form-12

  The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)

• International Physical Activity Questionnaire (IPAQ)

  The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1); 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)

Study Arms (2)

TELE-pre group

EXPERIMENTAL

Subjects in the TELE-prehabilitation group receive remote prehabilitation using advanced technologies.

Other: Tele-prehabilitation

Control group

ACTIVE COMPARATOR

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.

Other: Standard prehabilitation

Interventions

Tele-prehabilitation OTHER

Preoperative tele-rehabilitation using a virtual reality system.

TELE-pre group

Standard prehabilitation OTHER

Preoperative home-based rehabilitation delivered with a printed booklet for the Con-O subjects and no intervention for the Con-Y subjects.

Control group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Body Mass Index \> 30;
• Ongoing oncological diseases;
• Sampling area infection;
• HIV, HCV, HBV, TPHA infection;

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead
• Ministry of Health, Italy: collaborator

Study Sites (2)

IRCCS Istituto Clinico San Siro

Milan, 20148, Italy

NOT YET RECRUITING

IRCCS Ospedale Galeazzi - Sant'Ambrogio (Coordinator)

Milan, 20157, Italy

RECRUITING

Related Publications (27)

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  PMID: 37793919 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Laura Mangiavini

  IRCCS Galeazzi - Sant'Ambrogio Hospital

  PRINCIPAL INVESTIGATOR

• Giuseppe Peretti

  IRCCS Istituto Clinico San Siro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Guida

CONTACT

3471606501; stefania.guida@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The forty-eight subjects undergoing prehabilitation will be randomly allocated to one of the two possible intervention arms (tele-prehabilitation or standard prehabilitation). The twenty healthy young subject will not undergo any prehabilitation and will not be allocated to one of the two prehabilitation arms.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 29, 2022
• Study Start: January 1, 2023
• Primary Completion: February 10, 2025
• Study Completion: May 10, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

IT (2)