Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty
NCT Number: NCT06565377
Acronym: MULTIPREP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Arthroplasty
Interventions: BEHAVIORAL: Multimodal biopsychosocial teleprehabilitation|OTHER: Best-evidence prehabilitation advice
Sponsor: Universitair Ziekenhuis Brussel
Collaborators: Vrije Universiteit Brussel|Ziekenhuis Geel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07-31
Completion Date: 2026-09
Locations: Ziekenhuis Geel, Geel, Antwerpen, 2440, Belgium|Universitair Ziekenhuis Brussel, Brussels, Brussels Hoofdstedelijk Gewest, 1090, Belgium

Summary:
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.

Primary Outcome Measures: 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., assessed throughout the duration of the participant recruitment for the trial|Patient satisfaction with the intervention (feeling of contentment with the intervention), This will be assessed by qualitative in-depth interviews with the study participants., at 6 weeks post-surgery|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., At the end of each intervention session + throughout the duration of the study|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., Within one week after intervention completion|Compliance with home exercises, Patients will be asked to log their home exercise sessions in an intervention log book. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed., Within one week after intervention completion|Feasibility of BPS-teleprehab in the clinical setting, The feasibility of BPS-teleprehab in the clinical setting will be investigated by qualitative focus group discussions with healthcare providers involved in the care trajectory of people undergoing total knee arthroplasty., through study completion
Secondary Outcome Measures: Physical activity (objective measure), Actigraphy (Fitbit), 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), International Physical Activity Questionnaire, 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, Knee Injury and Osteoarthritis Outcome Score (KOOS), scale from 0-100, higher scores indicate better outcome, 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, EQ-5D-5L (Euroqol); scale from 0-100; higher scores indicate better quality of life, Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.|Symptoms of central sensitization, Central Sensitization Inventory; scale from 0-100; higher scores indicate more symptoms of central sensitization, Baseline, 6 months, 12 months post-surgery.|Pain catastrophizing, Pain Catastrophizing Scale; scale from 0-52; higher scores indicate higher levels of pain catastrophizing, 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, Tampa Scale for Kinesiophobia; scores from 17-68; higher scores indicate higher levels of fear of movement, 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, Patient-reported questionnaire based on Neupert et al. (2009); scores from 9-36; higher scores indicate greater exercise-related self-efficacy, 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, Forgotten Joint Score; sores from 0 to 100; high values translating to the patient successfully "forgetting" about their joint during activities of daily living, Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.|Satisfaction with surgery, 4-item satisfaction questionnaire; scores from 0-20; higher scores indicating higher levels of contentment with the surgery, 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, Knee Replacement Expectations Survey; scores from 0-100; higher scores indicate higher expectations, Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.|Overall change following knee replacement surgery, Global Rating of Change; scores from -3 to +3; more positive scores indicate a more positive change, Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.|Healthcare and medication use, (Modified) Medical Consumption Questionnaire, Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.|Productivity loss/return to work, Productivity Cost Questionnaire, 6 months and 12 months post-surgery.
Other Outcome Measures: 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., Throughout the duration of the study