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NCT Number: NCT06341920

BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hull University Teaching Hospitals

Hull, United Kingdom

Location status: Recruiting

Location contact

Lee Ingle

CONTACT

[email protected]

About this study

The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life & reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.

Currently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
  • Able to provide informed consent;

Exclusion criteria

  • Previous hip or knee surgery;
  • Any medical conditions for which moderate to vigorous exercise is contraindicated;
  • Patellar or hip joint instability;
  • Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;
  • Chronic depression or significant psychiatric disorder;
  • Enrolled in a clinical trial (or recently completed one);
  • Cognitive impairment which would affect compliance to BoneFIt service;
  • Patients unable or unwilling to commit to required study follow-ups
  • Pregnancy;

Treatment and study plan

Experimental: BoneFit intervention

Behavioral

Exercise, nutrition and psychological support provided in 8 weeks prior to surgery

Placebo Comparator: Control

Behavioral

Control group receive usual care (zero intervention)

Primary outcomes

  1. Recruitment

    Time frame: 2 years

    Number of people recruited and trained

  2. Adherence and attendance

    Time frame: 2.5 years

    Record the number of sessions attended and calculate adherence to protocol (%)

  3. Acceptability

    Time frame: 3 years

    Conduct semi-structured interviews following the intervention with sample of participants and ask them about experiences of the intervention. The post-intervention interviews will focus on how participants viewed the intervention, perceived burdens, and perceived effectiveness from initiation through to completion. A list of burdens / perceived benefits will be reported alongside percentage rates of respondents.

Secondary outcomes

  1. Physical fitness

    Time frame: 3 years

    Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)

  2. Length of stay

    Time frame: 3 years

    Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.

  3. Readmission rates

    Time frame: 3 years

    Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)

  4. Overall quality of life

    Time frame: 3 years

    Compare quality of life scores (intervention v controls) using EQ-5D-5L questionnaire. Index scores range between zero and one, based on 5-point Likert scale, with scores closer to one indicating an improved status.

  5. Knee or hip specific pain, function and quality of life

    Time frame: 3 years

    Compare knee or hip specific quality of life scores (intervention v controls). For knee replacements, the KOOS-12 is scored between 0-100 on 5-point Likert scale, with higher scores equating to improved status. For hip replacements, HOOS-12 scores between 0 to 4 points with 0 representing no hip problems and 4 representing extreme hip problems, based on response to 5-point Likert scale.

Study contacts

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

Lee Ingle

CONTACT

[email protected]

01482 463141

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Collaborators

  • Hull University Teaching Hospitals NHS Trust

Registry information

Official study title

BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull

Acronym: BoneFit

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2024
Registry last updated
Jun 12, 2024

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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