BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

Orthopedic Disorder Clinical Trial

— BoneFit  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341920
• Other study ID #: RS198 - 332551
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: June 2024
• Source: University of Hull
• Contact: Lee Ingle
• Phone: 01482 463141
• Email: L.Ingle[@]hull.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Behavioral:
• Experimental: BoneFit intervention
Exercise, nutrition and psychological support provided in 8 weeks prior to surgery
• Placebo Comparator: Control
Control group receive usual care (zero intervention)

Locations

Country	Name	City	State
United Kingdom	Hull University Teaching Hospitals	Hull

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	Hull University Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of people recruited and trained	2 years
Primary	Adherence and attendance	Record the number of sessions attended and calculate adherence to protocol (%)	2.5 years
Primary	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	Physical fitness	Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)	3 years
Secondary	Length of stay	Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.	3 years
Secondary	Readmission rates	Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)	3 years
Secondary	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
Secondary	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