Total Knee ArthroplastyMULTIPREPNCT06565377
Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty
A study testing Multimodal biopsychosocial teleprehabilitation and Best-evidence prehabilitation advice in people with Total Knee Arthroplasty, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial summary
Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Multimodal biopsychosocial teleprehabilitation and Best-evidence prehabilitation advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBelgium
- Study dates
- 31 Jul 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People scheduled for elective primary TKA at one of the participating hospitals;
- Being over 18 years old;
- Dutch speaking/reading
Who cannot join
- Doing activities that make them feel out of breath for 300 minutes or more per week on average;
- Orthopedic, neurological, cardiovascular or any other condition/comorbidity that leads to an overall contraindication for moderate physical activity;
- Cognitive impairment (≥11 on 6-item Cognitive Impairment Test and/or unable to understand the study instructions);
- Presence of uncontrolled inflammatory arthritides (e.g., rheumatoid arthritis, gout);
- Uncontrolled psychiatric disorders;
- Active cancer and/or active cancer treatment ((hormonal) maintenance therapy is allowed);
- People undergoing emergency (non-elective) TKA.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
Eva Huysmans, PhD, +32 2 477 44 20, eva.huysmans@vub.be
Johan Vanlauwe, PhD
- Recruiting
Ziekenhuis Geel
Geel, Antwerpen, 2440
Eva Huysmans, PhD, +32 2 477 44 20, eva.huysmans@vub.be
Hans Feyen, MD
About this study
Official title: The Added Value of Multimodal Biopsychosocial Teleprehabilitation in People Undergoing Total Knee Arthroplasty: a Pilot/Feasibility Trial
Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of pre-surgical biopsychosocial patient preparation. Such preparation aims to optimally inform patients before their surgery and to start preparing them for rehabilitation and resumption of activities after surgery. Therefore, we aim to assess the added value and feasibility of prehabilitation within the knee replacement care pathway.
The primary objective is to investigate the feasibility, acceptability and safety of multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) for people undergoing total knee arthroplasty (TKA).
Read more
The secondary objective is to explore the effect of BPS-teleprehab versus best-evidence preoperative advice for people undergoing TKA on activity outcomes, functioning, pain, symptoms of central sensitization, quality of life, cognitive-emotional factors, joint awareness, satisfaction with the surgery, healthcare and medication use and productivity loss.
The tertiary objective is to explore baseline associations between the collected outcome measures, demographics and medical data in people scheduled for TKA.
Furthermore, this pilot trial will inform potential protocol modifications in prepara- tion of an eventual fully powered randomized controlled trial to investigate the ef- fectiveness of BPS-teleprehab in people undergoing TKA.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Multimodal biopsychosocial teleprehabilitation, Best-evidence prehabilitation advice
- Keywords
- total knee arthroplasty, knee replacement, prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal biopsychosocial teleprehabilitationBehavioural
Also called prehabilitation
Multimodal biopsychosocial teleprehabilitation containing (pain science and lifestyle) education, stress management and physical activity promotion, guided by shared decision making, motivational interviewing and solution focused therapy principles.
Format: 4 preoperative and 1 postoperative one-on-one (tele-)conferencing sessions with a physical therapist, supplemented by an informational booklet.
Best-evidence prehabilitation adviceOther
Best-evidence prehabilitation advice in accordance with the NICE guideline on Joint Replacement (Primary): hip, knee and shoulder (2020), by means of an informational booklet.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) | Experimental | see intervention description Receives: Behavioral: Multimodal biopsychosocial teleprehabilitation |
| Best-evidence prehabilitation advice (control) | Active comparator | see intervention description Receives: Other: Best-evidence prehabilitation advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate
This will be calculated as the ratio of the number of patients participating in the study to the number of patients eligible for study participation.
Measured: assessed throughout the duration of the participant recruitment for the trial
Patient satisfaction with the intervention (feeling of contentment with the intervention)
This will be assessed by qualitative in-depth interviews with the study participants.
Measured: at 6 weeks post-surgery
Incidence of treatment-emergent adverse events (safety and tolerability)
After each intervention session, patients of the experimental group will be asked whether they experienced any side effects or unexpected events associated with the intervention. Furthermore, participants are encouraged to report any side effects/unexpected events to the study team at any time throughout the study.
Measured: At the end of each intervention session + throughout the duration of the study
Compliance with the one-on-one BPS-teleprehab sessions
The compliance rate for the teleprehabilitation sessions will be calculated as the ratio of the number of followed treatment sessions versus the number of planned treatment sessions.
Measured: Within one week after intervention completion
Compliance with home exercises
Patients will be asked to log their home exercise sessions in an intervention log book. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed.
Measured: Within one week after intervention completion
Feasibility of BPS-teleprehab in the clinical setting
The feasibility of BPS-teleprehab in the clinical setting will be investigated by qualitative focus group discussions with healthcare providers involved in the care trajectory of people undergoing total knee arthroplasty.
Measured: through study completion
Secondary outcomes (14)
Physical activity (objective measure)
Actigraphy (Fitbit)
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.
Physical activity (patient-reported outcome)
International Physical Activity Questionnaire
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.
Knee-specific pain and functioning
Knee Injury and Osteoarthritis Outcome Score (KOOS), scale from 0-100, higher scores indicate better outcome
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Health-related quality of life
EQ-5D-5L (Euroqol); scale from 0-100; higher scores indicate better quality of life
Measured: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Symptoms of central sensitization
Central Sensitization Inventory; scale from 0-100; higher scores indicate more symptoms of central sensitization
Measured: Baseline, 6 months, 12 months post-surgery.
Pain catastrophizing
Pain Catastrophizing Scale; scale from 0-52; higher scores indicate higher levels of pain catastrophizing
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Fear of movement and/or (re)injury
Tampa Scale for Kinesiophobia; scores from 17-68; higher scores indicate higher levels of fear of movement
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Perceived Self-efficacy to exercise
Patient-reported questionnaire based on Neupert et al. (2009); scores from 9-36; higher scores indicate greater exercise-related self-efficacy
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Joint awareness of the replaced joint
Forgotten Joint Score; sores from 0 to 100; high values translating to the patient successfully "forgetting" about their joint during activities of daily living
Measured: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Satisfaction with surgery
4-item satisfaction questionnaire; scores from 0-20; higher scores indicating higher levels of contentment with the surgery
Measured: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Total knee arthroplasty expectations
Knee Replacement Expectations Survey; scores from 0-100; higher scores indicate higher expectations
Measured: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.
Overall change following knee replacement surgery
Global Rating of Change; scores from -3 to +3; more positive scores indicate a more positive change
Measured: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Healthcare and medication use
(Modified) Medical Consumption Questionnaire
Measured: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Productivity loss/return to work
Productivity Cost Questionnaire
Measured: 6 months and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start31 Jul 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Ziekenhuis Geel
- Responsible party
- Sponsor
- Investigators
- Eva Huysmans, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565377
- Sponsor's protocol ID
- 12AV224N
- Acronym
- MULTIPREP
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open access data sharing is not possible due to the high degree of confidentiality of the pseudonymized medical and personal data. Data sharing (of pseudonymized data) is only permitted if all involved parties agree and if a data sharing agreement is signed. The research data need to be archived under restricted access due to the level of confidentiality of coded medical data. Requests for data sharing will be considered by the steering board. The informed consent allows for pseudonimyzed data sharing under these restricted conditions.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Multimodal Biopsychosocial Teleprehabilitation in People Undergoing Total Knee Arthroplasty: a Pilot/Feasibility Trial
- ClinicalTrials.gov ID
- NCT06565377
- Acronym / sponsor ID
- MULTIPREP / 12AV224N
- Conditions
- Total Knee Arthroplasty
- Keywords
- total knee arthroplasty, knee replacement, prehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Ziekenhuis Geel
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Aug 2024 (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.
Knee replacement surgeries are one of the most frequently performed elective surgeries, with approximately 29,000 such procedures carried out annually in Belgium. Although these surgeries have been increasingly refined over the years, leading to better surgical outcomes, there is still room for improvement in terms of pre-surgical biopsychosocial patient preparation. Such preparation aims to optimally inform patients before their surgery and to start preparing them for rehabilitation and resumption of activities after surgery. Therefore, we aim to assess the added value and feasibility of prehabilitation within the knee replacement care pathway.
The primary objective is to investigate the feasibility, acceptability and safety of multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) for people undergoing total knee arthroplasty (TKA).
The secondary objective is to explore the effect of BPS-teleprehab versus best-evidence preoperative advice for people undergoing TKA on activity outcomes, functioning, pain, symptoms of central sensitization, quality of life, cognitive-emotional factors, joint awareness, satisfaction with the surgery, healthcare and medication use and productivity loss.
The tertiary objective is to explore baseline associations between the collected outcome measures, demographics and medical data in people scheduled for TKA.
Furthermore, this pilot trial will inform potential protocol modifications in prepara- tion of an eventual fully powered randomized controlled trial to investigate the ef- fectiveness of BPS-teleprehab in people undergoing TKA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) | Experimental | Behavioral: Multimodal biopsychosocial teleprehabilitationsee intervention description |
| Best-evidence prehabilitation advice (control) | Active comparator | Other: Best-evidence prehabilitation advicesee intervention description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People scheduled for elective primary TKA at one of the participating hospitals;
- Being over 18 years old;
- Dutch speaking/reading
Key exclusion criteria (7 listed)
- Doing activities that make them feel out of breath for 300 minutes or more per week on average;
- Orthopedic, neurological, cardiovascular or any other condition/comorbidity that leads to an overall contraindication for moderate physical activity;
- Cognitive impairment (≥11 on 6-item Cognitive Impairment Test and/or unable to understand the study instructions);
- Presence of uncontrolled inflammatory arthritides (e.g., rheumatoid arthritis, gout);
- Uncontrolled psychiatric disorders;
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 |
|---|---|---|
| Multimodal biopsychosocial teleprehabilitationAlso: prehabilitationMultimodal biopsychosocial teleprehabilitation containing (pain science and lifestyle) education, stress management and physical activity promotion, guided by shared decision making, motivational interviewing and solution focused therapy principles. Format: 4 preoperative and 1 postoperative one-on-one (tele-)conferencing sessions with a physical therapist, supplemented by an informational booklet. | Behavioural | Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) |
| Best-evidence prehabilitation adviceBest-evidence prehabilitation advice in accordance with the NICE guideline on Joint Replacement (Primary): hip, knee and shoulder (2020), by means of an informational booklet. | Other | Best-evidence prehabilitation advice (control) |
Primary outcome
Participation rate
Time frame: assessed throughout the duration of the participant recruitment for the trial
This will be calculated as the ratio of the number of patients participating in the study to the number of patients eligible for study participation.
Patient satisfaction with the intervention (feeling of contentment with the intervention)
Time frame: at 6 weeks post-surgery
This will be assessed by qualitative in-depth interviews with the study participants.
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: At the end of each intervention session + throughout the duration of the study
After each intervention session, patients of the experimental group will be asked whether they experienced any side effects or unexpected events associated with the intervention. Furthermore, participants are encouraged to report any side effects/unexpected events to the study team at any time throughout the study.
Compliance with the one-on-one BPS-teleprehab sessions
Time frame: Within one week after intervention completion
The compliance rate for the teleprehabilitation sessions will be calculated as the ratio of the number of followed treatment sessions versus the number of planned treatment sessions.
Compliance with home exercises
Time frame: Within one week after intervention completion
Patients will be asked to log their home exercise sessions in an intervention log book. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed.
Feasibility of BPS-teleprehab in the clinical setting
Time frame: through study completion
The feasibility of BPS-teleprehab in the clinical setting will be investigated by qualitative focus group discussions with healthcare providers involved in the care trajectory of people undergoing total knee arthroplasty.
14 secondary outcomes
Physical activity (objective measure)
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.
Physical activity (patient-reported outcome)
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.
Knee-specific pain and functioning
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Health-related quality of life
Time frame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Symptoms of central sensitization
Time frame: Baseline, 6 months, 12 months post-surgery.
Pain catastrophizing
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Fear of movement and/or (re)injury
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Perceived Self-efficacy to exercise
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Joint awareness of the replaced joint
Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Satisfaction with surgery
Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Total knee arthroplasty expectations
Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.
Overall change following knee replacement surgery
Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Healthcare and medication use
Time frame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Productivity loss/return to work
Time frame: 6 months and 12 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. Open access data sharing is not possible due to the high degree of confidentiality of the pseudonymized medical and personal data. Data sharing (of pseudonymized data) is only permitted if all involved parties agree and if a data sharing agreement is signed. The research data need to be archived under restricted access due to the level of confidentiality of coded medical data. Requests for data sharing will be considered by the steering board. The informed consent allows for pseudonimyzed data sharing under these restricted conditions.
Related trials for Total Knee Arthroplasty
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruitingObservational study
VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
Total Knee Arthroplasty (TKA)
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
Not yet recruitingPhase 4
Oral Tranexamic Acid After Total Knee Arthroplasty
Total Knee Arthroplasty
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.
Eva Huysmans, PhD principal investigator
Vrije Universiteit Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal biopsychosocial teleprehabilitation and Best-evidence prehabilitation advice in people with Total Knee Arthroplasty, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Huysmans, PhD (+32 2 477 44 20, eva.huysmans@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: assessed throughout the duration of the participant recruitment for the trial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.