BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery (BoneFit)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Behavioral: Experimental: BoneFit intervention; Behavioral: Placebo Comparator: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lee Ingle; Phone Number: 01482 463141; Email: L.Ingle@hull.ac.uk

Study Locations

• United Kingdom
  • Hull, United Kingdom
    • Recruiting
    • Hull University Teaching Hospitals
    • Contact: Lee Ingle; Email: L.Ingle@hull.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BoneFit intervention; Participants will receive a personalised care plan comprising exercise, nutrition and psychological wellbeing based on individual need in the 8-week period prior to surgery	Behavioral: Experimental: BoneFit intervention; Exercise, nutrition and psychological support provided in 8 weeks prior to surgery
Placebo Comparator: Control; Participants who are allocated to this group will receive baseline tests and will be invited to re-attend 3 months post surgery to re-do tests. This group will receive usual care (no intervention). The groups will be compared.	Behavioral: Placebo Comparator: Control; Control group receive usual care (zero intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Number of people recruited and trained	2 years
Adherence and attendance	Record the number of sessions attended and calculate adherence to protocol (%)	2.5 years
Acceptability	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical fitness	Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)	3 years
Length of stay	Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.	3 years
Readmission rates	Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)	3 years
Overall quality of life	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.	3 years
Knee or hip specific pain, function and quality of life	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.	3 years

Collaborators and Investigators

• Sponsor: University of Hull
• Collaborators: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Lee Ingle, Professor of Exercise Science for Health and Rehabiliation

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: surgery; prehabilitation; optimisation; surgical preparation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: RS198 - 332551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Please contact the PI and request access to data
• IPD Sharing Time Frame: Dec 2027
• IPD Sharing Access Criteria: Request from PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No