Orthopedic DisorderBoneFitNCT06341920
BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
A study testing Experimental: BoneFit intervention in people with Orthopedic Disorder, run by University of Hull at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Experimental: BoneFit intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
- Able to provide informed consent;
Who cannot join
- 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);
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- Cognitive impairment which would affect compliance to BoneFIt service;
- Patients unable or unwilling to commit to required study follow-ups
- Pregnancy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull University Teaching Hospitals
Hull
Lee Ingle, L.Ingle@hull.ac.uk
About this study
Official title: BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- Experimental: BoneFit intervention, Placebo Comparator: Control
- Keywords
- prehabilitation, optimisation, surgery, surgical preparation
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: BoneFit interventionBehavioural
Exercise, nutrition and psychological support provided in 8 weeks prior to surgery
Placebo Comparator: ControlBehavioural
Control group receive usual care (zero intervention)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Placebo Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of people recruited and trained
Measured: 2 years
Adherence and attendance
Record the number of sessions attended and calculate adherence to protocol (%)
Measured: 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.
Measured: 3 years
Secondary outcomes (5)
Physical fitness
Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)
Measured: 3 years
Length of stay
Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.
Measured: 3 years
Readmission rates
Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 May 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention v control
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lee Ingle, Principal investigator, Professor of Exercise Science for Health and Rehabiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341920
- Sponsor's protocol ID
- RS198 - 332551
- Acronym
- BoneFit
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the PI and request access to data
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.
PubMed 39937759
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
- ClinicalTrials.gov ID
- NCT06341920
- Acronym / sponsor ID
- BoneFit / RS198 - 332551
- Conditions
- Orthopedic Disorder
- Keywords
- prehabilitation, optimisation, surgery, surgical preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention v control
| Arm | Type | Receives |
|---|---|---|
| BoneFit intervention | Experimental | Behavioral: Experimental: BoneFit interventionParticipants will receive a personalised care plan comprising exercise, nutrition and psychological wellbeing based on individual need in the 8-week period prior to surgery |
| Control | Placebo comparator | Behavioral: Placebo Comparator: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
- Able to provide informed consent;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: BoneFit interventionExercise, nutrition and psychological support provided in 8 weeks prior to surgery | Behavioural | BoneFit intervention |
| Placebo Comparator: ControlControl group receive usual care (zero intervention) | Behavioural | Control |
Primary outcome
Recruitment
Time frame: 2 years
Number of people recruited and trained
Adherence and attendance
Time frame: 2.5 years
Record the number of sessions attended and calculate adherence to protocol (%)
Acceptability
Time frame: 3 years
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 39937759Ingle 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.
- Individual participant dataSharing planned: Yes. Please contact the PI and request access to data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee Ingle principal investigator
Professor of Exercise Science for Health and Rehabiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: BoneFit intervention in people with Orthopedic Disorder, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Ingle (01482 463141, L.Ingle@hull.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.