Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)

see intervention description

Group Type EXPERIMENTAL

Multimodal biopsychosocial teleprehabilitation

Intervention Type 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 (control)

see intervention description

Group Type ACTIVE_COMPARATOR

Best-evidence prehabilitation advice

Intervention Type 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.

Interventions

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Multimodal biopsychosocial teleprehabilitation

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.

Intervention Type BEHAVIORAL

Best-evidence prehabilitation advice

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.

Intervention Type OTHER

Other Intervention Names

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prehabilitation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No