An interventional study of Experimental: BoneFit intervention and Placebo Comparator: Control in Orthopedic Disorder, sponsored by University of Hull. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by University of Hull · Not applicable, Interventional, and Treatment
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.
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 50 is below the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University of Hull is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Exercise, nutrition and psychological support provided in 8 weeks prior to surgery
Control group receive usual care (zero intervention)
Recruitment
Number of people recruited and trained
Time frame: 2 years
Adherence and attendance
Record the number of sessions attended and calculate adherence to protocol (%)
Time frame: 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.
Time frame: 3 years
Physical fitness
Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)
Time frame: 3 years
Length of stay
Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.
Time frame: 3 years
Readmission rates
Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)
Time frame: 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.
Time frame: 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.
Time frame: 3 years
Plan to share: Yes — Please contact the PI and request access to data
Supporting information: Study protocol
Time frame: Dec 2027
Access criteria: Request from PI
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University of Hull