Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

NCT06565377 | Recruiting DMC

• 1 other identifier: 12AV224N
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Knee Arthroplasty

Keywords

total knee arthroplasty; knee replacement; prehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• 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.

• 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.

• 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.

• Health-related quality of life

  Baseline, 6 weeks post-surgery, 6 months post-surgery (primary endpoint), 12 months post-surgery.

• Symptoms of central sensitization

  Baseline, 6 months, 12 months post-surgery.

Other Outcomes (1)

• Focus groups with healthcare providers

  Throughout the duration of the study

Study Arms (2)

Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)

EXPERIMENTAL

see intervention description

Behavioral: Multimodal biopsychosocial teleprehabilitation

Best-evidence prehabilitation advice (control)

ACTIVE COMPARATOR

see intervention description

Other: Best-evidence prehabilitation advice

Interventions

Multimodal biopsychosocial teleprehabilitation BEHAVIORAL

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.

Also known as: prehabilitation

Multimodal biopsychosocial teleprehabilitation (BPS-teleprehab)

Best-evidence prehabilitation advice OTHER

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.

Best-evidence prehabilitation advice (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People scheduled for elective primary TKA at one of the participating hospitals;
• Being over 18 years old;
• Dutch speaking/reading

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• Ziekenhuis Geel: collaborator

Study Sites (2)

Ziekenhuis Geel

Geel, Antwerpen, 2440, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eva Huysmans, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Huysmans, PhD

CONTACT

+32 2 477 44 20; eva.huysmans@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 22, 2024
• Study Start: July 31, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Requests for data sharing can be considered once the main results of the trial have been published.
• 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.

Locations

BE (2)