BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

NCT ID: NCT06341920

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2027-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthopedic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention v control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BoneFit intervention

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

Group Type EXPERIMENTAL

Experimental: BoneFit intervention

Intervention Type BEHAVIORAL

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

Control

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Control

Intervention Type BEHAVIORAL

Control group receive usual care (zero intervention)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental: BoneFit intervention

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

Intervention Type BEHAVIORAL

Placebo Comparator: Control

Control group receive usual care (zero intervention)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role collaborator

University of Hull

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lee Ingle

Role: PRINCIPAL_INVESTIGATOR

Professor of Exercise Science for Health and Rehabiliation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hull University Teaching Hospitals

Hull, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lee Ingle

Role: CONTACT

01482 463141

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lee Ingle

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39937759 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RS198 - 332551

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transfemoral Powered Foot and Physical Therapy Study
NCT03625921 ACTIVE_NOT_RECRUITING NA