About this 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).

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

This trial does not accept healthy volunteers

Qualifiers

People scheduled for elective primary TKA at one of the participating hospitals;

Being over 18 years old;

Dutch speaking/reading

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)Experimental treatment 1 intervention

Group B: Best-evidence prehabilitation advice (control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

assessed throughout the duration of the participant recruitment for the trial

2

Patient satisfaction with the intervention (feeling of contentment with the intervention)

This will be assessed by qualitative in-depth interviews with the study participants.

Time frame

at 6 weeks post-surgery

3

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.

Time frame

At the end of each intervention session + throughout the duration of the study

4

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.

Time frame

Within one week after intervention completion

Secondary outcomes

1

Physical activity (objective measure)

Actigraphy (Fitbit)

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.

2

Physical activity (patient-reported outcome)

International Physical Activity Questionnaire

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.

3

Knee-specific pain and functioning

Knee Injury and Osteoarthritis Outcome Score (KOOS), scale from 0-100, higher scores indicate better 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.

4

Health-related quality of life

EQ-5D-5L (Euroqol); scale from 0-100; higher scores indicate better quality of life

Time frame

Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.

Other outcomes

1

Focus groups with healthcare providers

Focus group discussions with healthcare providers involved in the care trajectory of people undergoing total knee arthroplasty concerning the feasibility of multimodal biopsychosocial teleprehabilitation in clinical practice.

Time frame

Throughout the duration of the study

Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts