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BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06341920
Acronym
BoneFit
Enrollment
50
Registered
2024-04-02
Start date
2024-05-16
Completion date
2027-12-01
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder

Keywords

prehabilitation, optimisation, surgery, surgical preparation

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.

Interventions

BEHAVIORALExperimental: BoneFit intervention

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

Control group receive usual care (zero intervention)

Sponsors

Hull University Teaching Hospitals NHS Trust
CollaboratorOTHER_GOV
University of Hull
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.

Intervention model description

Intervention v control

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Recruitment2 yearsNumber of people recruited and trained
Adherence and attendance2.5 yearsRecord the number of sessions attended and calculate adherence to protocol (%)
Acceptability3 yearsConduct 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

MeasureTime frameDescription
Overall quality of life3 yearsCompare 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.
Physical fitness3 yearsCompare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)
Knee or hip specific pain, function and quality of life3 yearsCompare 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.
Length of stay3 yearsCompare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.
Readmission rates3 yearsCompare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)

Countries

United Kingdom

Contacts

Primary ContactLee Ingle
L.Ingle@hull.ac.uk01482 463141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026