Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Physical activity (objective measure) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Symptoms of central sensitization [Срок оценки: Baseline, 6 months, 12 months post-surgery.]
• Pain catastrophizing [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]
• Satisfaction with surgery [Срок оценки: 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 [Срок оценки: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.]
• Overall change following knee replacement surgery [Срок оценки: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.]

Критерии участия

Критерии включения

• People scheduled for elective primary TKA at one of the participating hospitals;
• Being over 18 years old;
• Dutch speaking/reading

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Бельгия · 2 центра

• Ziekenhuis Geel — Geel
• Universitair Ziekenhuis Brussel — Brussels

Идентификаторы

NCT: NCT06565377 · 12AV224N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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