Clinical trial NCT06565377: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: total knee arthroplasty
knee replacement
prehabilitation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Ziekenhuis Geel
First posted: 2024-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Participation rate
timeFrame: assessed throughout the duration of the participant recruitment for the trial
measure: Patient satisfaction with the intervention (feeling of contentment with the intervention)
timeFrame: at 6 weeks post-surgery
measure: Incidence of treatment-emergent adverse events (safety and tolerability)
timeFrame: At the end of each intervention session + throughout the duration of the study
measure: Compliance with the one-on-one BPS-teleprehab sessions
timeFrame: Within one week after intervention completion
measure: Compliance with home exercises
timeFrame: Within one week after intervention completion
measure: Feasibility of BPS-teleprehab in the clinical setting
timeFrame: through study completion
Secondary outcomes:
measure: Physical activity (objective measure)
timeFrame: 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.
measure: Physical activity (patient-reported outcome)
timeFrame: 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.
measure: Knee-specific pain and functioning
timeFrame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Health-related quality of life
timeFrame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Symptoms of central sensitization
timeFrame: Baseline, 6 months, 12 months post-surgery.
measure: Pain catastrophizing
timeFrame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Fear of movement and/or (re)injury
timeFrame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Perceived Self-efficacy to exercise
timeFrame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Joint awareness of the replaced joint
timeFrame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Satisfaction with surgery
timeFrame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Total knee arthroplasty expectations
timeFrame: Baseline, post-intervention (day 4-7 post-surgery), 6 weeks post-surgery.
measure: Overall change following knee replacement surgery
timeFrame: Post-intervention (day 4-7 post-surgery), 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Healthcare and medication use
timeFrame: Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.
measure: Productivity loss/return to work
timeFrame: 6 months and 12 months post-surgery.
Other outcomes:
measure: Focus groups with healthcare providers
timeFrame: Throughout the duration of the study
Locations:
city: Geel
country: Belgium
facility: Ziekenhuis Geel
state: Antwerpen
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Vrije Universiteit Brussel
name: Eva Huysmans, PhD
role: PRINCIPAL_INVESTIGATOR
References: