Knee OsteoarthritisNCT05668312
Effects of Tele-prehabilitation in Patients Waiting for Knee Replacement
A study testing Tele-prehabilitation and Standard prehabilitation in people with Knee Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tele-prehabilitation and Standard prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2023to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Both sexes of any ethnicity;
- Age between 18 and 35 years;
- Scheduled Anterior Cruciate Ligament reconstruction surgery;
- Body Mass Index ≤ 30.
Who cannot join
- 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;
Show all 18Show fewer
- 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;
- Known neuromuscular/muscular diseases;
- Ongoing non-suspendable anticoagulant therapies,
- Female subjects in pregnancy status or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS Istituto Clinico San Siro
Milan, 20148
Giuseppe Peretti, 02487851, giuseppe.peretti@grupposandonato.it
- Recruiting
IRCCS Ospedale Galeazzi - Sant'Ambrogio (Coordinator)
Milan, 20157
Laura Mangiavini, 0283500010, laura.mangiavini@unimi.it
About this study
Official title: Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial
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.
Read the detailed 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:
- Warm-up (about 5 minutes)
- Knee bending and extension in lying position;
- Knee extensions while sitting;
- Get on tiptoes in standing position;
- March on site.
- Working phase (about 30 minutes)
- Hip bending keeping the knee extended in lying position;
- Hip motion in space planes (imagining of drawing numbers with the tiptoe);
- Hip abduction keeping the knee extended side lying;
- Knee bending and hip extension in standing position;
- Half squat;
- Half lateral lunge;
- Monopodalic standing;
- Tandem walking;
- Weight shifting on unstable surface.
- Cool-down (about 5 minutes)
- Free walk;
- 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tele-prehabilitation, Standard prehabilitation
- Keywords
- Tele-prehabilitation, Prehabilitation, Virtual Reality, Advanced technologies, Knee osteoarthritis, Arthroplasty, Replacement, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-prehabilitationOther
Preoperative tele-rehabilitation using a virtual reality system.
Standard prehabilitationOther
Preoperative home-based rehabilitation delivered with a printed booklet for the Con-O subjects and no intervention for the Con-Y subjects.
| Study group | Role | What they receive |
|---|---|---|
| TELE-pre group | Experimental | Subjects in the TELE-prehabilitation group receive remote prehabilitation using advanced technologies. Receives: 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. Receives: Other: Standard prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)
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.
Measured: 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 NPRS is an 11-point scale from 0 to 10 assessing pain. "0" is "no pain", "10" is "the most intense pain imaginable".
Measured: 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 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.
Measured: 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 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.
Measured: 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)
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.
Measured: 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)
Knee extensor and flexors maximal strength assessment
Maximal strength will be assessed using a dynamometer and expressed in kilograms (Kg).
Measured: 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)
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.
Measured: 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)
Knee Range Of Motion
Knee motion in flexion and extension is measured using a goniometer and expressed in degree.
Measured: 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)
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.
Measured: 6/7 weeks after T0.
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.
Measured: 6/7 weeks after T0.
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.
Measured: The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)
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.
Measured: The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Jan 2023
- Primary completion10 Feb 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Laura Mangiavini, Principal investigator, IRCCS Galeazzi - Sant'Ambrogio HospitalGiuseppe Peretti, Principal investigator, IRCCS Istituto Clinico San Siro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668312
- Sponsor's protocol ID
- Tele-prehabilitation
- Status last verified
- Jan 2024
- First submitted
- 22 Nov 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romanini E, Decarolis F, Luzi I, Zanoli G, Venosa M, Laricchiuta P, Carrani E, Torre M. Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty. Int Orthop. 2019 Jan;43(1):133-138. doi: 10.1007/s00264-018-4165-7. Epub 2018 Oct 6.
PubMed 30293141Erivan R, Tardieu A, Villatte G, Ollivier M, Jacquet C, Descamps S, Boisgard S. Knee surgery trends and projections in France from 2008 to 2070. Orthop Traumatol Surg Res. 2020 Sep;106(5):893-902. doi: 10.1016/j.otsr.2020.02.018. Epub 2020 Jun 4.
PubMed 32507586Hitzl W, Heisinger S, Hobusch GM, Frank K, Cotofana S. Projected numbers of primary total knee replacement in Austria from 2015-2075. Orthopade. 2019 Feb;48(2):144-149. doi: 10.1007/s00132-018-3605-9.
PubMed 30051278Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.
PubMed 30988126Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
PubMed 31663402L Snell D, Hipango J, Sinnott KA, Dunn JA, Rothwell A, Hsieh CJ, DeJong G, Hooper G. Rehabilitation after total joint replacement: a scoping study. Disabil Rehabil. 2018 Jul;40(14):1718-1731. doi: 10.1080/09638288.2017.1300947. Epub 2017 Mar 23.
PubMed 28330380Vasta S, Papalia R, Torre G, Vorini F, Papalia G, Zampogna B, Fossati C, Bravi M, Campi S, Denaro V. The Influence of Preoperative Physical Activity on Postoperative Outcomes of Knee and Hip Arthroplasty Surgery in the Elderly: A Systematic Review. J Clin Med. 2020 Mar 31;9(4):969. doi: 10.3390/jcm9040969.
PubMed 32244426Jette DU, Hunter SJ, Burkett L, Langham B, Logerstedt DS, Piuzzi NS, Poirier NM, Radach LJL, Ritter JE, Scalzitti DA, Stevens-Lapsley JE, Tompkins J, Zeni J Jr; American Physical Therapy Association. Physical Therapist Management of Total Knee Arthroplasty. Phys Ther. 2020 Aug 31;100(9):1603-1631. doi: 10.1093/ptj/pzaa099.
PubMed 32542403Moyer R, Ikert K, Long K, Marsh J. The Value of Preoperative Exercise and Education for Patients Undergoing Total Hip and Knee Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Dec;5(12):e2. doi: 10.2106/JBJS.RVW.17.00015.
PubMed 29232265Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Feasibility and preliminary effects of a tele-prehabilitation program and an in-person prehablitation program compared to usual care for total hip or knee arthroplasty candidates: a pilot randomized controlled trial. Disabil Rehabil. 2020 Apr;42(7):989-998. doi: 10.1080/09638288.2018.1515992. Epub 2019 Jan 13.
PubMed 30638076Sharif F, Rahman A, Tonner E, Ahmed H, Haq I, Abbass R, Asinger S, Sbai M. Can technology optimise the pre-operative pathway for elective hip and knee replacement surgery: a qualitative study. Perioper Med (Lond). 2020 Nov 16;9(1):33. doi: 10.1186/s13741-020-00166-0.
PubMed 33292556McDonnell JM, Ahern DP, Ross TD, Gibbons D, Synnott KA, Butler JS. The efficacy of remote virtual care in comparison to traditional clinical visits for elective orthopaedic patients: A meta-analysis of prospective randomised controlled trials. Surgeon. 2022 Jun;20(3):177-186. doi: 10.1016/j.surge.2021.02.008. Epub 2021 Mar 21.
PubMed 33762159Wang Q, Lee RLT, Hunter S, Chan SW. The effectiveness of internet-based telerehabilitation among patients after total joint arthroplasty: An integrative review. Int J Nurs Stud. 2021 Mar;115:103845. doi: 10.1016/j.ijnurstu.2020.103845. Epub 2020 Dec 6.
PubMed 33360248Harmelink KEM, Zeegers AVCM, Tonis TM, Hullegie W, Nijhuis-van der Sanden MWG, Staal JB. The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Jul 5;18(1):290. doi: 10.1186/s12891-017-1647-5.
PubMed 28679400Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.
PubMed 30816849
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tele-prehabilitation on Clinical and Muscular Recover in Patients Waiting for Knee Replacement: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05668312
- Acronym / sponsor ID
- Tele-prehabilitation
- Conditions
- Knee Osteoarthritis
- Keywords
- Tele-prehabilitation, Prehabilitation, Virtual Reality, Advanced technologies, Knee osteoarthritis, Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Warm-up (about 5 minutes)
- Knee bending and extension in lying position;
- Knee extensions while sitting;
- Get on tiptoes in standing position;
- March on site.
- Working phase (about 30 minutes)
- Hip bending keeping the knee extended in lying position;
- Hip motion in space planes (imagining of drawing numbers with the tiptoe);
- Hip abduction keeping the knee extended side lying;
- Knee bending and hip extension in standing position;
- Half squat;
- Half lateral lunge;
- Monopodalic standing;
- Tandem walking;
- Weight shifting on unstable surface.
- Cool-down (about 5 minutes)
- Free walk;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TELE-pre group | Experimental | Other: Tele-prehabilitationSubjects in the TELE-prehabilitation group receive remote prehabilitation using advanced technologies. |
| Control group | Active comparator | Other: Standard prehabilitationThe 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Both sexes of any ethnicity;
- Age between 18 and 35 years;
- Scheduled Anterior Cruciate Ligament reconstruction surgery;
- Body Mass Index ≤ 30.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-prehabilitationPreoperative tele-rehabilitation using a virtual reality system. | Other | TELE-pre group |
| Standard prehabilitationPreoperative home-based rehabilitation delivered with a printed booklet for the Con-O subjects and no intervention for the Con-Y subjects. | Other | Control group |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6/7 weeks
Time frame: The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1).
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).
13 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 7 +/- 2 days after surgery (T2); 15 +/- 2 days after surgery (T3); 90 +/- 7 days after surgery (T4)
Oxford Knee Score (OKS)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Sit-to-stand test
Time frame: 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)
Knee extensor and flexors maximal strength assessment
Time frame: 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)
Timed Up-and-Go test
Time frame: 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)
Knee Range Of Motion
Time frame: 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)
Satisfaction interview
Time frame: 6/7 weeks after T0.
Prehabilitation diary
Time frame: 6/7 weeks after T0.
Muscle metabolism markers
Time frame: The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)
Blood biomarkers
Time frame: The day of the recruitment (T0); the day of surgery (T1); 90 +/- 7 days after surgery (T4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Background: PubMed 30293141Romanini E, Decarolis F, Luzi I, Zanoli G, Venosa M, Laricchiuta P, Carrani E, Torre M. Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty. Int Orthop. 2019 Jan;43(1):133-138. doi: 10.1007/s00264-018-4165-7. Epub 2018 Oct 6.
- Background: PubMed 32507586Erivan R, Tardieu A, Villatte G, Ollivier M, Jacquet C, Descamps S, Boisgard S. Knee surgery trends and projections in France from 2008 to 2070. Orthop Traumatol Surg Res. 2020 Sep;106(5):893-902. doi: 10.1016/j.otsr.2020.02.018. Epub 2020 Jun 4.
- Background: PubMed 30051278Hitzl W, Heisinger S, Hobusch GM, Frank K, Cotofana S. Projected numbers of primary total knee replacement in Austria from 2015-2075. Orthopade. 2019 Feb;48(2):144-149. doi: 10.1007/s00132-018-3605-9.
- Background: PubMed 30988126Singh JA, Yu S, Chen L, Cleveland JD. Rates of Total Joint Replacement in the United States: Future Projections to 2020-2040 Using the National Inpatient Sample. J Rheumatol. 2019 Sep;46(9):1134-1140. doi: 10.3899/jrheum.170990. Epub 2019 Apr 15.
- Background: PubMed 31663402Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
- Background: PubMed 28330380L Snell D, Hipango J, Sinnott KA, Dunn JA, Rothwell A, Hsieh CJ, DeJong G, Hooper G. Rehabilitation after total joint replacement: a scoping study. Disabil Rehabil. 2018 Jul;40(14):1718-1731. doi: 10.1080/09638288.2017.1300947. Epub 2017 Mar 23.
- Background: PubMed 32244426Vasta S, Papalia R, Torre G, Vorini F, Papalia G, Zampogna B, Fossati C, Bravi M, Campi S, Denaro V. The Influence of Preoperative Physical Activity on Postoperative Outcomes of Knee and Hip Arthroplasty Surgery in the Elderly: A Systematic Review. J Clin Med. 2020 Mar 31;9(4):969. doi: 10.3390/jcm9040969.
- Background: PubMed 32542403Jette DU, Hunter SJ, Burkett L, Langham B, Logerstedt DS, Piuzzi NS, Poirier NM, Radach LJL, Ritter JE, Scalzitti DA, Stevens-Lapsley JE, Tompkins J, Zeni J Jr; American Physical Therapy Association. Physical Therapist Management of Total Knee Arthroplasty. Phys Ther. 2020 Aug 31;100(9):1603-1631. doi: 10.1093/ptj/pzaa099.
- Background: PubMed 29232265Moyer R, Ikert K, Long K, Marsh J. The Value of Preoperative Exercise and Education for Patients Undergoing Total Hip and Knee Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Dec;5(12):e2. doi: 10.2106/JBJS.RVW.17.00015.
- Background: PubMed 30638076Doiron-Cadrin P, Kairy D, Vendittoli PA, Lowry V, Poitras S, Desmeules F. Feasibility and preliminary effects of a tele-prehabilitation program and an in-person prehablitation program compared to usual care for total hip or knee arthroplasty candidates: a pilot randomized controlled trial. Disabil Rehabil. 2020 Apr;42(7):989-998. doi: 10.1080/09638288.2018.1515992. Epub 2019 Jan 13.
- Background: PubMed 33292556Sharif F, Rahman A, Tonner E, Ahmed H, Haq I, Abbass R, Asinger S, Sbai M. Can technology optimise the pre-operative pathway for elective hip and knee replacement surgery: a qualitative study. Perioper Med (Lond). 2020 Nov 16;9(1):33. doi: 10.1186/s13741-020-00166-0.
- Background: PubMed 33762159McDonnell JM, Ahern DP, Ross TD, Gibbons D, Synnott KA, Butler JS. The efficacy of remote virtual care in comparison to traditional clinical visits for elective orthopaedic patients: A meta-analysis of prospective randomised controlled trials. Surgeon. 2022 Jun;20(3):177-186. doi: 10.1016/j.surge.2021.02.008. Epub 2021 Mar 21.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Mangiavini principal investigator
IRCCS Galeazzi - Sant'Ambrogio Hospital
Giuseppe Peretti principal investigator
IRCCS Istituto Clinico San Siro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-prehabilitation and Standard prehabilitation in people with Knee Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Guida (3471606501, stefania.guida@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6/7 weeks (time frame: The day of the recruitment (T0); 6/7 weeks after T0, the day of surgery (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668312, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.