Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial

Stefania Guida; Jacopo Vitale; Silvia Gianola; Greta Castellini; Eva Swinnen; David Beckwée; Cecilia Gelfi; Enrica Torretta; Laura Mangiavini

doi:10.1136/bmjopen-2023-073163

Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial

Stefania Guida, Jacopo Vitale, Silvia Gianola, Greta Castellini, Eva Swinnen, David Beckwée, Cecilia Gelfi, Enrica Torretta, Laura Mangiavini

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Abstract

BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement.

METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses.

ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications.

TRIAL REGISTRATION NUMBER: NCT05668312.

Original language	English
Article number	e073163
Pages (from-to)	1-8
Number of pages	8
Journal	BMJ Open
Volume	13
Issue number	10
DOIs	https://doi.org/10.1136/bmjopen-2023-073163
Publication status	Published - 2023

Bibliographical note

Keywords

Humans
Male
Arthroplasty, Replacement, Knee
Preoperative Exercise
Exercise Therapy/methods
Osteoarthritis, Knee/surgery
Costs and Cost Analysis
Treatment Outcome
Randomized Controlled Trials as Topic

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title = "Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial",

abstract = "BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement.METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses.ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications.TRIAL REGISTRATION NUMBER: NCT05668312.",

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Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement : protocol of a randomised controlled trial. / Guida, Stefania; Vitale, Jacopo; Gianola, Silvia; Castellini, Greta; Swinnen, Eva ; Beckwée, David; Gelfi, Cecilia; Torretta, Enrica; Mangiavini, Laura.

In: BMJ Open, Vol. 13, No. 10, e073163, 2023, p. 1-8.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement

T2 - protocol of a randomised controlled trial

AU - Guida, Stefania

AU - Vitale, Jacopo

AU - Gianola, Silvia

AU - Castellini, Greta

AU - Swinnen, Eva

AU - Beckwée, David

AU - Gelfi, Cecilia

AU - Torretta, Enrica

AU - Mangiavini, Laura

N1 - © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023

Y1 - 2023

N2 - BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement.METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses.ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications.TRIAL REGISTRATION NUMBER: NCT05668312.

AB - BACKGROUND: The increasing prevalence of knee osteoarthritis and total knee arthroplasty (TKA) impose a significant socioeconomic burden in developed and developing countries. Prehabilitation (rehabilitation in the weeks immediately before surgery) may be crucial to prepare patients for surgery improving outcomes and reducing assistance costs. Moreover, considering the progress of telemedicine, candidates for TKA could potentially benefit from a tele-prehabilitation programme. We aim to evaluate the effects of a home-based tele-prehabilitation program for patients waiting for total knee replacement.METHODS AND ANALYSIS: Forty-eight male patients, aged 65-80, on a waiting list for TKA will be recruited and randomly assigned to the tele-prehabilitation intervention or control groups. Both groups will undergo the same 6-week exercise program (five sessions/week) and the same educational session (one per week). The tele-prehabilitation group will perform asynchronous sessions using a tablet, two accelerometers and a balance board (Khymeia, Padova, Italy), while the control group will use a booklet. The Western Ontario and McMaster Universities Osteoarthritis Index Questionnaire, at the end of the prehabilitation, will be the primary outcome. Secondary outcomes will include self-reported outcomes, performance tests and change in expressions of blood and muscle biomarkers. Ten healthy subjects, aged 18-30, will be also recruited for muscle and blood samples collection. They will not undergo any intervention and their data will be used as benchmarks for the intervention and control groups' analyses.ETHICS AND DISSEMINATION: This randomised controlled trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki. This study has been approved by the Ethics Committee of Vita-Salute San Raffaele University (Milan, Italy. No. 50/INT/2022). The research results will be published in peer-reviewed publications.TRIAL REGISTRATION NUMBER: NCT05668312.

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KW - Male

KW - Arthroplasty, Replacement, Knee

KW - Preoperative Exercise

KW - Exercise Therapy/methods

KW - Osteoarthritis, Knee/surgery

KW - Costs and Cost Analysis

KW - Treatment Outcome

KW - Randomized Controlled Trials as Topic

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Effects of tele-prehabilitation on clinical and muscular recovery in patients awaiting knee replacement: protocol of a randomised controlled trial

Abstract

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