BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
- Conditions
- Orthopedic Disorder
- Registration Number
- NCT06341920
- Lead Sponsor
- University of Hull
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
- Able to provide informed consent;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment 2 years Number of people recruited and trained
Adherence and attendance 2.5 years Record the number of sessions attended and calculate adherence to protocol (%)
Acceptability 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 Outcome Measures
Name Time Method Readmission rates 3 years Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)
Length of stay 3 years Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.
Physical fitness 3 years Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)
Overall quality of life 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.
Knee or hip specific pain, function and quality of life 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.
Trial Locations
- Locations (1)
Hull University Teaching Hospitals
🇬🇧Hull, United Kingdom