BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

NCT06341920 | Recruiting DMC

• 1 other identifier: RS198 - 332551
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthopedic Disorder

Keywords

prehabilitation; optimisation; surgery; surgical preparation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Physical fitness

  3 years

• Length of stay

  3 years

• Readmission rates

  3 years

• Overall quality of life

  3 years

• Knee or hip specific pain, function and quality of life

  3 years

Study Arms (2)

BoneFit intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Experimental: BoneFit intervention BEHAVIORAL

Exercise, nutrition and psychological support provided in 8 weeks prior to surgery

BoneFit intervention

Placebo Comparator: Control BEHAVIORAL

Control group receive usual care (zero intervention)

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
• Able to provide informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Hull: lead
• Hull University Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Hull University Teaching Hospitals

Hull, United Kingdom

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Lee Ingle

  Professor of Exercise Science for Health and Rehabiliation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Ingle

CONTACT

01482 463141; L.Ingle@hull.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention v control

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 2, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Dec 2027
• Access Criteria: Request from PI

Locations

GB (1)