Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty (MULTIPREP)

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

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 Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Behavioral: Multimodal biopsychosocial teleprehabilitation; Other: Best-evidence prehabilitation advice

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Huysmans, PhD; Phone Number: +32 2 477 44 20; Email: eva.huysmans@vub.be

Study Locations

• Belgium
  • Antwerpen
    • Geel, Antwerpen, Belgium, 2440
      • Not yet recruiting
      • Ziekenhuis Geel
      • Contact: Eva Huysmans, PhD; Phone Number: +32 2 477 44 20; Email: eva.huysmans@vub.be
      • Sub-Investigator: Hans Feyen, MD
  • Brussels Hoofdstedelijk Gewest
    • Brussels, Brussels Hoofdstedelijk Gewest, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Eva Huysmans, PhD; Phone Number: +32 2 477 44 20; Email: eva.huysmans@vub.be
      • Sub-Investigator: Johan Vanlauwe, PhD
      • Sub-Investigator: Thierry Scheerlinck, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab); see intervention description	Behavioral: 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.; Other Names: prehabilitation
Active Comparator: Best-evidence prehabilitation advice (control); see intervention description	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Vrije Universiteit Brussel; Ziekenhuis Geel
• Investigators: Principal Investigator: Eva Huysmans, PhD, Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: total knee arthroplasty; prehabilitation; knee replacement
• Other Study ID Numbers: 12AV224N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Open access data sharing is not possible due to the high degree of confidentiality of the pseudonymized medical and personal data. Data sharing (of pseudonymized data) is only permitted if all involved parties agree and if a data sharing agreement is signed. The research data need to be archived under restricted access due to the level of confidentiality of coded medical data. Requests for data sharing will be considered by the steering board. The informed consent allows for pseudonimyzed data sharing under these restricted conditions.
• IPD Sharing Time Frame: Requests for data sharing can be considered once the main results of the trial have been published.
• IPD Sharing Access Criteria: Requests for data sharing will be considered by the steering board of the study who will screen the applicants and (relevance of the) proposed research questions. If considered appropriate and relevant, a data sharing agreement will be composed in cooperation with our data protection officer and legal department.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No