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NCT Number: NCT06565377

Multimodal Biopsychosocial Teleprehabilitation for Total Knee Arthroplasty

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Geel, Geel, Antwerpen, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: prehabilitation

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.

Primary outcomes

  1. Participation rate

    Time frame: 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.

  2. Patient satisfaction with the intervention (feeling of contentment with the intervention)

    Time frame: at 6 weeks post-surgery

    This will be assessed by qualitative in-depth interviews with the study participants.

  3. Incidence of treatment-emergent adverse events (safety and tolerability)

    Time frame: 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.

  4. Compliance with the one-on-one BPS-teleprehab sessions

    Time frame: 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.

  5. Compliance with home exercises

    Time frame: 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.

  6. Feasibility of BPS-teleprehab in the clinical setting

    Time frame: 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.

Secondary outcomes

  1. Physical activity (objective measure)

    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.

    Actigraphy (Fitbit)

  2. Physical activity (patient-reported 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. Actigraphy data will be registered for 1 week prior to the assessment moment for the remaining outcomes.

    International Physical Activity Questionnaire

  3. Knee-specific pain and functioning

    Time frame: 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

  4. Health-related quality of life

    Time frame: 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

  5. Symptoms of central sensitization

    Time frame: Baseline, 6 months, 12 months post-surgery.

    Central Sensitization Inventory; scale from 0-100; higher scores indicate more symptoms of central sensitization

  6. 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.

    Pain Catastrophizing Scale; scale from 0-52; higher scores indicate higher levels of pain catastrophizing

  7. Fear of movement and/or (re)injury

    Time frame: 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

  8. Perceived Self-efficacy to exercise

    Time frame: 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

  9. Joint awareness of the replaced joint

    Time frame: 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

  10. Satisfaction with surgery

    Time frame: 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

  11. Total knee arthroplasty expectations

    Time frame: 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

  12. Overall change following knee replacement surgery

    Time frame: 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

  13. Healthcare and medication use

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

    (Modified) Medical Consumption Questionnaire

  14. Productivity loss/return to work

    Time frame: 6 months and 12 months post-surgery.

    Productivity Cost Questionnaire

Other outcomes

  1. Focus groups with healthcare providers

    Time frame: Throughout the duration of the study

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Huysmans, PhD

CONTACT

[email protected]

+32 2 477 44 20

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Vrije Universiteit Brussel
  • Ziekenhuis Geel

Registry information

Official study title

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

Acronym: MULTIPREP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 22, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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