Ignite Creation Date:
2025-12-18 @ 8:30 AM
Ignite Modification Date:
2025-12-23 @ 9:03 PM
Study NCT ID:
NCT05668312
Status:
None
Last Update Posted:
2024-01-12 00:00:00
First Post:
2022-11-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement
Sponsor:
None
Organization:
Study Overview
Official Title:
Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial
Status:
None
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: