Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty (MULTIPREP)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Other: Best-evidence prehabilitation advice; Behavioral: Multimodal biopsychosocial teleprehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06565377

12AV224N

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)

Experimental group

Description:

see intervention description

Treatment:

Behavioral: Multimodal biopsychosocial teleprehabilitation

Best-evidence prehabilitation advice (control)

Active Comparator group

Description:

see intervention description

Treatment:

Other: Best-evidence prehabilitation advice