Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668312
• Other study ID #: Tele-prehabilitation
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 10, 2025

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Galeazzi
• Contact: Stefania Guida
• Phone: 3471606501
• Email: stefania.guida[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Based on the existing literature, we expected to observe an effect size of 0.8 in WOMAC (primary outcome) between groups at the end of the tele-prehabilitation program. Therefore, considering a test power of 80% and an alpha error of 5%, we have computed a sample size of 48 subjects, 24 for each group (taking into account a possible drop-out rate of 15-20%).

Twenty healthy young subjects (10 males and 10 females) will be also recruited only for muscle and blood samples collection, that will be used as benchmarks for the intervention and control groups analyses (they will no undergo any prehabilitation program).

The recruited subjects will be randomly allocated (with a 1:1 ratio randomization list) in the tele-prehabilitation or in the control groups. During the 6 weeks just before surgery, both groups will perform 5 sessions a week of the same home-based prehabilitation program. Each session is planned as follow: 5 minutes of warm-up, 30 minutes of work (mobility, strengthening and balance exercises) and 5 minutes of cool-down.

In details, for each session subjects will perform the following exercises:

1. Warm-up (about 5 minutes)

1. Knee bending and extension in lying position;

2. Knee extensions while sitting;

3. Get on tiptoes in standing position;

4. March on site.

2. Working phase (about 30 minutes)

1. Hip bending keeping the knee extended in lying position;

2. Hip motion in space planes (imagining of drawing numbers with the tiptoe);

3. Hip abduction keeping the knee extended side lying;

4. Knee bending and hip extension in standing position;

5. Half squat;

6. Half lateral lunge;

7. Monopodalic standing;

8. Tandem walking;

9. Weight shifting on unstable surface.

3. Cool-down (about 5 minutes)

1. Free walk;

2. Leg swings while sitting.

Subjects of both groups will also have to read, once a week, an educational content (digital for the tele-prehabilitation group, printed for the control one) dealing with:

• Information about knee osteoarthritis and replacement;

• Post-operative symptoms, what to expect;

• Advices for home organization after surgery;

• Healthy life style: physical activity, nutrition and sleep;

• Advices for maintaining progresses;

• Motivational intervention.

The tele-prehabilitation program will be delivered using the following devices (Khymeia, Padova, Italy -Khymeia - e-health innovation):

• TeleCockpit, a workstation used by the clinician to manage remotely patient's home device, interact real-time or check the adherence to treatment;

• VRRS Home Tablet, with an uploaded mobile application for the exercises execution at home;

• VRRS Khymu, two accelerometers for patient's interaction with the virtual reality system during knee motion;

• VRRS Balance, a balance board for patient's interaction with the virtual reality system during centre-of-mass motion.

The exercise volume of the "work" section of the prehabilitative session will increase during the 6 weeks according to patient's symptoms. This progression will be based on the score, measured at the end of each workout, obtained at the Borg CR-10 scale self-administered by the patient at the end of each session. A score below 5 indicates the need to increase the workload in the next session. The progression of the working volume will be considered and eventually managed weekly by the clinician in charge, for the intervention group connecting to the patient's device with the TeleCockpit workstation, and for the control group by communicating the changes in the prescription details with a phone call.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Tele-prehabilitation
Preoperative tele-rehabilitation using a virtual reality system.
• Standard prehabilitation
Preoperative home-based rehabilitation delivered with a printed booklet for the Con-O subjects and no intervention for the Con-Y subjects.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Clinico San Siro	Milan
Italy	IRCCS Ospedale Galeazzi - Sant'Ambrogio (Coordinator)	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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).	7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)
Secondary	Oxford Knee Score (OKS)	The OKS is a self-administrated questionnaire assessing symptoms and function in patients undergoing knee replacement. It is composed by 12 items and uses a 5-point Likert scale.	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)
Secondary	Numeric Pain Rating Scale (NPRS)	The NPRS is an 11-point scale from 0 to 10 assessing pain. "0" is "no pain", "10" is "the most intense pain imaginable".	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)
Secondary	Short Form-12	The Short Form-12 is questionnaire for health assessment, composed by 12 items, which can be self-administrated or completed through an interview. An algorithm is used to obtain the final composite score.	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)
Secondary	International Physical Activity Questionnaire (IPAQ)	The IPAQ is a 9-item self-reported measure of physical activity. Adding up the week minutes of walking, moderate-intensity activity and vigorous-intense activity, multiplied per specific coefficients, the questionnaire estimate the overall Metabolic Equivalent of Task.	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)
Secondary	Sit-to-stand test	The subject is asked to stand-up and sit-down on a chair, standardized in size, for 5 consecutive times as much faster as he can. Time (in seconds) to complete the task is representative of the lower limb strength.	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)
Secondary	Knee extensor and flexors maximal strength assessment	Maximal strength will be assessed using a dynamometer and expressed in kilograms (Kg).	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)
Secondary	Timed Up-and-Go test	The subject is asked, starting from seated on a chair, to stand-up, walk 3m, go back to the chair and sit-down. Time (in seconds) to complete the task is representative of the subject's risk of fall.	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)
Secondary	Knee Range Of Motion	Knee motion in flexion and extension is measured using a goniometer and expressed in degree.	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)
Secondary	Satisfaction interview	This interview is a 6-item self-reported measure of participant's satisfaction about the prehabilitation delivery modality, which uses a 11-point Likert scale.; This interview has been created ad hoc for this study.	6/7 weeks after T0.
Secondary	Prehabilitation diary	This diary has been created ad hoc to assess participant's adherence to treatment. The measure of adherence is expressed by the total number of sessions reported in the diary.; It will be used only to assess adherence of the Con-O group.	6/7 weeks after T0.
Secondary	Muscle metabolism markers	Muscle will be sampled by needle aspiration (for participants belonging to Tele-pre or Con-O groups) or discarded muscle material collection during surgical procedures.; In collected muscle samples, myosin heavy chain (MHC) isoform distribution will be assessed by SDS-PAGE electrophoresis, while levels of markers as PGC1alpha will be investigated by ELISA or Western Blot. Proteomics analysis will be conducted by LC-MS, using TMT quantification, whereas lipidomics and sphingolipidomics analyses will be conducted by untargeted and targeted LC-MS.	The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)
Secondary	Blood biomarkers	Blood sample will taken according to standard procedures. Levels of proteins or lipids suggested to be potential biomarkers will be investigated in collected sera, by ELISA or MRM-MS.	The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)