Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty
- Conditions
- Total Knee Arthroplasty
- Interventions
- Behavioral: Multimodal biopsychosocial teleprehabilitationOther: Best-evidence prehabilitation advice
- Registration Number
- NCT06565377
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- People scheduled for elective primary TKA at one of the participating hospitals;
- Being over 18 years old;
- Dutch speaking/reading
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab) Multimodal biopsychosocial teleprehabilitation see intervention description Best-evidence prehabilitation advice (control) Best-evidence prehabilitation advice see intervention description
- Primary Outcome Measures
Name Time Method Participation rate assessed throughout the duration of the participant recruitment for the trial 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.
Patient satisfaction with the intervention (feeling of contentment with the intervention) at 6 weeks post-surgery This will be assessed by qualitative in-depth interviews with the study participants.
Compliance with the one-on-one BPS-teleprehab sessions Within one week after intervention completion 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.
Feasibility of BPS-teleprehab in the clinical setting through study completion 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.
Incidence of treatment-emergent adverse events (safety and tolerability) At the end of each intervention session + throughout the duration of the study 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.
Compliance with home exercises Within one week after intervention completion 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.
- Secondary Outcome Measures
Name Time Method Productivity loss/return to work 6 months and 12 months post-surgery. Productivity Cost Questionnaire
Knee-specific pain and functioning Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS), scale from 0-100, higher scores indicate better outcome
Symptoms of central sensitization Baseline, 6 months, 12 months post-surgery. Central Sensitization Inventory; scale from 0-100; higher scores indicate more symptoms of central sensitization
Pain catastrophizing Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Pain Catastrophizing Scale; scale from 0-52; higher scores indicate higher levels of pain catastrophizing
Fear of movement and/or (re)injury Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Tampa Scale for Kinesiophobia; scores from 17-68; higher scores indicate higher levels of fear of movement
Perceived Self-efficacy to exercise Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Patient-reported questionnaire based on Neupert et al. (2009); scores from 9-36; higher scores indicate greater exercise-related self-efficacy
Total knee arthroplasty expectations Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery. Knee Replacement Expectations Survey; scores from 0-100; higher scores indicate higher expectations
Physical activity (patient-reported outcome) 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. International Physical Activity Questionnaire
Health-related quality of life Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. EQ-5D-5L (Euroqol); scale from 0-100; higher scores indicate better quality of life
Physical activity (objective measure) 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. Actigraphy (Fitbit)
Joint awareness of the replaced joint Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Forgotten Joint Score; sores from 0 to 100; high values translating to the patient successfully "forgetting" about their joint during activities of daily living
Satisfaction with surgery Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. 4-item satisfaction questionnaire; scores from 0-20; higher scores indicating higher levels of contentment with the surgery
Overall change following knee replacement surgery Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. Global Rating of Change; scores from -3 to +3; more positive scores indicate a more positive change
Healthcare and medication use Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery. (Modified) Medical Consumption Questionnaire
Trial Locations
- Locations (2)
Ziekenhuis Geel
🇧🇪Geel, Antwerpen, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Brussels Hoofdstedelijk Gewest, Belgium