Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

Official title

The Added Value of Multimodal Biopsychosocial Teleprehabilitation in People Undergoing Total Knee Arthroplasty: a Pilot/Feasibility Trial

Overview

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.

Interventions

• Behavioral 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.
• Other 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.

Primary outcome measures

• Participation rate [Time frame: assessed throughout the duration of the participant recruitment for the trial]
• Patient satisfaction with the intervention (feeling of contentment with the intervention) [Time frame: at 6 weeks post-surgery]
• Incidence of treatment-emergent adverse events (safety and tolerability) [Time frame: At the end of each intervention session + throughout the duration of the study]
• Compliance with the one-on-one BPS-teleprehab sessions [Time frame: Within one week after intervention completion]
• Compliance with home exercises [Time frame: Within one week after intervention completion]
• Feasibility of BPS-teleprehab in the clinical setting [Time frame: through study completion]

Secondary outcome measures (12)

• Physical activity (objective measure) [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.]
• Physical activity (patient-reported 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. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.]
• Knee-specific pain and functioning [Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Health-related quality of life [Time frame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Symptoms of central sensitization [Time frame: Baseline, 6 months, 12 months post-surgery.]
• Pain catastrophizing [Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Fear of movement and/or (re)injury [Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Perceived Self-efficacy to exercise [Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Joint awareness of the replaced joint [Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Satisfaction with surgery [Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Total knee arthroplasty expectations [Time frame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.]
• Overall change following knee replacement surgery [Time frame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Belgium · 2 centers

• Ziekenhuis Geel — Geel
• Universitair Ziekenhuis Brussel — Brussels

Identifiers

NCT: NCT06565377 · 12AV224N

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗