Optimisation of the preparation phase for orthopaedic surgery: Study protocol for a student-led multimodal prehabilitation feasibility trial (BoneFit).
Lee Ingle, Joanna Snook, Lois Smith...
https://pubmed.ncbi.nlm.nih.gov/39937759Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06341920
BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
Led by University of Hull · Updated on 2024-06-12
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Hull
Lead Sponsor
H
Hull University Teaching Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a student-led multimodal prehabilitation service called BoneFit for people preparing for total hip or knee replacement surgery. The study aims to improve physical and mental health, quality of life, and reduce hospital stay length, complications, and readmission rates for patients undergoing orthopedic surgery in the Hull region. This pilot feasibility study will compare BoneFit to usual care, as no prehabilitation service is currently offered locally. Participants in the BoneFit intervention group will receive a personalized care plan that includes exercise, nutrition, and psychological support tailored to their needs during the 8 weeks before surgery. A control group will receive usual care without intervention. The groups will be compared to assess the impact of the prehabilitation service. During the study, participants will undergo baseline tests and will be invited to repeat these assessments 3 months after surgery. Researchers will monitor recruitment, attendance, and acceptability over several years. They will also measure physical fitness, hospital length of stay, readmission rates, overall quality of life, and specific pain and function related to the knee or hip. The study will last up to 3 years, with ongoing follow-up assessments to evaluate outcomes.
CONDITIONS
Brief Title
BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months
- Able to provide informed consent
- Age between 18 and 75 years
You will not qualify if you...
- Previous hip or knee surgery
- Any medical conditions for which moderate to vigorous exercise is contraindicated
- Patellar or hip joint instability
- Any other disease or condition which severely affects functional performance, such as 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 8 weeks
Participants receive a personalised care plan comprising exercise, nutrition, and psychological support in the 8 weeks prior to surgery.
Multiple visits over 8 weeks
Surgery
Duration - Day of surgery
Participants undergo unilateral total hip or knee replacement surgery.
1 visit (in-person)
Post-operative Follow-up
Duration - 3 months post surgery
Participants are invited to re-attend 3 months post surgery to re-do tests and assessments.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hull University Teaching Hospitals
Hull, United Kingdom
Actively Recruiting
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Research Team
L
Lee Ingle
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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