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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
60
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 in accordance with the NICE guideline on Joint Replacement (Primary): hip, knee and shoulder (2020), by means of an informational booklet.
Ziekenhuis Geel
Geel, Antwerpen, Belgium
NOT_YET_RECRUITINGUniversitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
RECRUITINGParticipation 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
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
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
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
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.
Time frame: 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.
Time frame: through study completion
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.
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.
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.
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.
Symptoms of central sensitization
Central Sensitization Inventory; scale from 0-100; higher scores indicate more symptoms of central sensitization
Time frame: Baseline, 6 months, 12 months post-surgery.
Pain catastrophizing
Pain Catastrophizing Scale; scale from 0-52; higher scores indicate higher levels of 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tampa Scale for Kinesiophobia; scores from 17-68; higher scores indicate higher levels of fear of movement
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
Patient-reported questionnaire based on Neupert et al. (2009); scores from 9-36; higher scores indicate greater exercise-related self-efficacy
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
Forgotten Joint Score; sores from 0 to 100; high values translating to the patient successfully "forgetting" about their joint during activities of daily living
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
4-item satisfaction questionnaire; scores from 0-20; higher scores indicating higher levels of contentment with the 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
Knee Replacement Expectations Survey; scores from 0-100; higher scores indicate higher expectations
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
Productivity loss/return to work
Productivity Cost Questionnaire
Time frame: 6 months and 12 months post-surgery.