Health TrialsbyHealthPanel

BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

ConditionOrthopedic Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Hull

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;

Able to provide informed consent;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: BoneFit intervention

    Behavioral

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

  • Placebo Comparator: Control

    Behavioral

    Control group receive usual care (zero intervention)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: BoneFit interventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment

Number of people recruited and trained

Time frame
2 years
2

Adherence and attendance

Record the number of sessions attended and calculate adherence to protocol (%)

Time frame
2.5 years
3

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

Secondary outcomes

1

Physical fitness

Compare incremental shuttle walk test scores (intervention v controls). Units: stage achieved and time taken (seconds)

Time frame
3 years
2

Length of stay

Compare days in hospital following surgery (intervention v controls). Units: hours in hospital following surgery.

Time frame
3 years
3

Readmission rates

Compare the % of patients in each group who were readmitted to hospital following surgery (intervention v controls)

Time frame
3 years
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hull

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov
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