BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

University of Hull

Status: Enrolling

Conditions: Orthopedic Disorder

Treatments: Behavioral: Placebo Comparator: Control; Behavioral: Experimental: BoneFit intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06341920

RS198 - 332551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

BoneFit intervention

Experimental group

Description:

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

Treatment:

Behavioral: Experimental: BoneFit intervention

Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Placebo Comparator: Control