NCT06565377 Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty
| NCT ID | NCT06565377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Total Knee Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-07-31 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * People scheduled for elective primary TKA at one of the participating hospitals; * Being over 18 years old; * Dutch speaking/reading Exclusion Criteria: * 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.
Contact & Investigator
Eva Huysmans, PhD
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT06565377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Knee Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06565377 currently recruiting?
Yes, NCT06565377 is actively recruiting participants. Contact the research team at eva.huysmans@vub.be for enrollment information.
Where is the NCT06565377 trial being conducted?
This trial is being conducted at Geel, Belgium, Brussels, Belgium.
Who is sponsoring the NCT06565377 clinical trial?
NCT06565377 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Eva Huysmans, PhD at Vrije Universiteit Brussel. The trial plans to enroll 40 participants.