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Recruiting NCT06341920

BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

No phase Interventional Orthopedic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: BoneFit intervention, Placebo Comparator: Control.
Who it may be relevant to
Registry conditions: Orthopedic Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Recruitment [Time frame: 2 years]
  • Adherence and attendance [Time frame: 2.5 years]
  • Acceptability [Time frame: 3 years]
Secondary outcome measures (5)
  • Physical fitness [Time frame: 3 years]
  • Length of stay [Time frame: 3 years]
  • Readmission rates [Time frame: 3 years]
  • Overall quality of life [Time frame: 3 years]
  • Knee or hip specific pain, function and quality of life [Time frame: 3 years]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Hull University Teaching Hospitals — Hull

Publications

  • Ingle L, Snook J, Smith L, Oliver B, Bray J, Wells L, Moorhouse J, Dixon L, Simpson P, Osman S, Saxton J, Rajendran A, Gopalakrishnan G, Symes T. Optimisation of the preparation phase for orthopaedic surgery: Study protocol for a student-led multimodal prehabilitation feasibility trial (BoneFit). PLoS One. 2025 Feb 12;20(2):e0314680. doi: 10.1371/journal.pone.0314680. eCollection 2025. PMID 39937759

Identifiers

NCT: NCT06341920 · RS198 - 332551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗