Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT06565377
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multimodal biopsychosocial teleprehabilitation — BEHAVIORAL
    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 advice — OTHER
    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 Details

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.

Key Dates

First listed
Aug 22, 2024
Start date
Jul 31, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)
    see intervention description
  • Active Comparator: Best-evidence prehabilitation advice (control)
    see intervention description

Primary Outcome Measure

Participation rate [ Time Frame: assessed throughout the duration of the participant recruitment for the trial ]

Central Contacts

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