BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
NCT ID: NCT06341920
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-05-16
2027-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Experimental: BoneFit intervention
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.
Placebo Comparator: Control
Control group receive usual care (zero intervention)
Interventions
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Experimental: BoneFit intervention
Exercise, nutrition and psychological support provided in 8 weeks prior to surgery
Placebo Comparator: Control
Control group receive usual care (zero intervention)
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent;
Exclusion Criteria
* 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;
18 Years
75 Years
ALL
No
Sponsors
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Hull University Teaching Hospitals NHS Trust
OTHER_GOV
University of Hull
OTHER
Responsible Party
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Principal Investigators
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Lee Ingle
Role: PRINCIPAL_INVESTIGATOR
Professor of Exercise Science for Health and Rehabiliation
Locations
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Hull University Teaching Hospitals
Hull, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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RS198 - 332551
Identifier Type: -
Identifier Source: org_study_id
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