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: Not yet recruiting

Administrative data

• NCT number: NCT06341920
• Other study ID #: RS198 - 332551
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: March 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: Not yet 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
n/a

Sponsors (2)

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

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