BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
Phase: NA
Conditions: Orthopedic Disorder
Sponsor: University of Hull

Version number and date: V4, 13-02-2024
IRAS ID: 332551
BoneFit: A Student-Led Multimodal Prehabilitation Service 
for Orthopaedic Surgical Patients in Hull
Introduction:
In the UK, there are >8 million surgical operations performed every year, and this 
is likely to continue to rise due to the increasing ageing population [1,2]. Surgery 
can lead to reduction in physical function, a loss of independence due to continued 
bed rest and deconditioning, increased pain and discomfort, and can lead to physi-
cal and mental complications including increased stress, anxiety and depression. 
These symptoms can lead to higher readmission rates and longer hospital stays [3]. 
Due to the recent global pandemic. surgical procedures were cancelled en masse 
leading to increasing waiting lists and, at an individual level, continued decondi-
tioning and an increasing risk of functional limitations particularly in the elderly. In 
the UK, prehabilitation is a single component of Early Recovery After Surgery 
(ERAS), a multi-step treatment package designed to help prepare individuals for 
the physical and mental insult of surgery. Being able to optimise an individual prior 
to surgery is likely to lead to improved patient outcomes and should save the NHS 
money by reducing the length of hospital stay, complications and readmission rates 
[4]. Prehabilitation interventions have evolved over the years becoming multi-
modal in nature. Interventions typically include exercise, nutrition, and psycholog-
ical support delivered by a multidisciplinary team [5]. 
In people receiving orthopaedic surgery, the evidence-base showing the positive 
impact of prehabilitation continues to grow. In 2023, a large-scale systematic re-
view and meta-analysis based on 48 unique trials involving 3,570 participants 
(61.5% female, mean age 64 years) reported level I moderate-certainty evidence 

supporting prehabilitation versus usual-care for improving pre-operative function 
and strength in people undergoing total knee replacement (TKR) surgery, and mod-
erate-certainty evidence for increased health-related quality of life (HRQoL) and 
muscle strength for individuals undergoing total hip replacement (THR) surgery [6]. 
Aims: The aim of BoneFit is to provide local people living in the Hull region with a 
needs-based prehabilitation care package (PCP) to improve their physical and men-
tal health, quality of life & reduce their length of hospital stay, complications and 
readmission rates to hospital following orthopaedic surgery (initially TKR and THR 
procedures). 
Currently, Hull University Teaching Hospitals (HUTH) do not offer a prehabilitation/
ERAS service for local patients. The University of Hull (UoH) will partner with 
HUTH to provide a student-led multimodal prehabilitation service for referred pa-
tients awaiting orthopaedic surgery (initially TKR or THR). This is a proof-of-con-
cept trial where external funding will be applied for to underpin and expand the 
service to support other specialities, if shown to be successful.
Only low-to-moderate risk patients will be initially referred to receive a PCP (risk 
score between 0 to 6). Patients who score >=7 points on the operative risk estima-
tion chart will not be referred (see final page of the GP referral form for full de-
tails of risk criteria). 
Study Start and End-dates
The study is planned to run from March/April 2024 to July 2027. We plan to recruit 
50 patients and controls (25 per group). Once these numbers have been achieved 
we will cease recruitment and just continue with the follow-up visits (final follow 
up is 12 months following surgery). 
￼2

• Inclusion criteria:
Age 18-75 years;
Waiting for unilateral TKR or THR surgery for a minimum of 6 months;
Able to provide informed consent;
• Exclusion criteria:
Previous TKR/THR 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;
Age <18 years or >75 years;
No access to smartphone or home internet;
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 and unwilling 
ness to work with students;
Pregnancy;
• UoH Student-Led PCPs:
All students will work under the guidance of a qualified professional based at the 
UoH. Multimodal prehabilitation involves the core disciplines of exercise, nutrition 
and clinical psychology. Therefore, students involved in the following programmes 
will help supply PCPs as part of their student placements, projects/dissertations or 
as part of an internship:
￼3

• BSc Physiotherapy
• BSc Sports Rehabilitation
• MSc Dietetics 
• BSc Sports Nutrition
• MSc Clinical Exercise Physiology
• MSc Cardiovascular Rehabilitation
• Clinical Psychology Doctorate
• Service Design:
Following guidance from the 2019 NHS Long Term Plan (https://www.-
longtermplan.nhs.uk/) we will use a personalised approach when developing the 
PCPs. Validated screening and assessment tools will enable assignment of partici-
pants. Those with no increased risk factors and with no increased surgical risk will 
receive universal support. Further assessment will be undertaken for those requir-
ing more than universal support and they will be allocated to targeted (intermedi-
ate risk/needs) or specialist (high risk/complex needs). Patients may receive dif-
ferent levels of support for the different intervention components: exercise, nutri-
tion and psychological support. 
Controls (usual care): In a non-randomised manner, we will identify a group of age- 
and sex-matched individuals referred for hip (THR) or knee replacement (TKR) 
surgery from patients who contact the BoneFit service. PIS forms will be circulated 
by clinical staff to eligible patients awaiting TKR/THR surgery in their routine clin-
ic at Castle Hill Hospital. Interested parties will contact the BoneFit service for 
more information. If patients agree to participate they will be invited to the Uni-
versity of Hull to provide consent and will undertake a series of baseline assess-
ments and will be allocated by BoneFit staff to the intervention or control group at 
this point. 
￼4

Current HUTH waiting list times for orthopaedic surgery is <18 months. Following 
referral, patients will be asked to complete DASI, download the (enhanced recov-
ery after surgery (ERAS+) app onto their smartphones and follow its guidance. If 
they do not have access to a smartphone, they will be referred to the ERAS+ web-
site, or if they have no internet connection, hard copies of generic guidance will 
be posted to them. At the 2-month point prior to surgery, they will be referred to 
the Hip-Hub for further evaluation and to receive their PCPs.   
The Hip-Hub (https://hiphub.hull.ac.uk/)- the UoH sports injuries clinic will man-
age the patient referral process and BoneFIt will benefit from existing referral, 
data management, facilities, equipment, and communication systems. Referred 
patients will initially be contacted by Hip-Hub staff and invited to attend for an 
initial screening session (see Screening, Assessment and Outcomes sections below). 
Validated screening tools and outcome measures will be used to determine the 
type of PCP required, and patient data will be recorded. The type of intervention 
received will depend on whether a patient requires universal, targeted or special-
ist PCPs. Students will stay in regular contact with patients to ascertain fidelity 
and compliance with the PCP.  
All students will be working under the support and guidance of trained clinical pro-
fessionals in physiotherapy, sports therapy, nutrition/dietetics, and clinical psy-
chology or clinical exercise physiology. Student-patient interactions will be deliv-
ered either in a face-to-face individual or group setting, virtual (one-to-one or 
group-based using Teams or equivalent) or via telephone. Sessions will mainly be 
delivered live although some pre-recorded material will be used to supplement live 
sessions and an online resources library will be built up over time.
Outcome measures for each of the three core components (exercise, nutrition and 
clinical psychology) will be evaluated at 5 timepoints (initial surgical referral e.g. 
18 months from surgery; baseline [2 months from surgery], immediately prior to 
surgery [2 to 10 days], and 3 and 12 months after surgery). See Table 1 to identify 
which outcome measures will be recorded. At initial surgical referral, DASI will be 
completed remotely. However, the remaining 4 timepoints will require face-to-face 
interactions and more in-depth investigations. 
￼5

Table 1. Outcome and timepoints assessments for individuals recruited to BoneFit
Variable/
Timepoint
2 months 
from 
surgery
2-10 days 
prior to 
surgery
3 months  
post op
12 months 
post op
Physical/
Exercise
DASI
✔︎
✔︎
✔︎
ISWT
✔︎
✔︎
✔︎
✔︎
Timed up 
and go
✔︎
✔︎
✔︎
✔︎
Hand-grip 
strength
✔︎
✔︎
✔︎
✔︎
HOOS-12 or 
KOOS-12
✔︎
✔︎
✔︎
✔︎
Nutrition
MUST
✔︎
✔︎
✔︎
✔︎
PG-SGA
✔︎
✔︎
✔︎
✔︎
Clinical 
Psychology
EQ-5D-5L 
(QoL)
✔︎
✔︎
✔︎
✔︎
￼6

DASI - Duke Activity Score Index; ISWT: incremental shuttle walk test; VAS: visual 
analogue scale; MUST: malnutrition universal screening tool; PG-SGA: patient-gen-
erated global assessment; GAD-7: generalised anxiety disorder assessment; PHQ-9: 
depression test score; EQ-5D-5L: health and quality of life questionnaire; HOOS-12: 
hip disability and osteoarthritis outcome score-12; KOOS-12: knee injury and os-
teoarthritis outcome score-12.
At initial surgical referral, all participants referred for BoneFIt will receive existing 
ERAS guidance on developing healthier lifestyle choices in preparation for surgery 
GAD-7
✔︎
✔︎
✔︎
✔︎
PHQ-9
✔︎
✔︎
✔︎
✔︎
Emotions 
thermomet
er
✔︎
✔︎
✔︎
✔︎
Clinical 
outcomes
Length of 
hospital 
stay 
✔︎
✔︎
Complicatio
ns
✔︎
✔︎
Re-
admission 
rates
✔︎
✔︎
VAS pain 
scale
✔︎
✔︎
✔︎
✔︎
￼7

(material delivered by post, or via app and website). It is important to intervene 
immediately after surgical referral as the longer people sit on a waiting list, the 
more deconditioned they become, and the harder it is to start making positive life-
style choices (low activators). Low mood can increase whilst waiting which can of-
ten exacerbate poor lifestyle choices e.g. increase tobacco use, poorer eating 
habits, wait gain, etc.
Study Outcomes:
• Primary objective
The primary outcome measures are feasibility and acceptability of the BoneFit in-
tervention. Feasibility will be assessed by determining the number of participants 
recruited, trained and retained at the end of the intervention, the proportion of 
intervention sessions delivered and fidelity of delivery. Moreover, participant re-
cruitment, retention and adherence to the intervention will be measured, as well 
as any adverse events. To determine the acceptability of the intervention and to 
explore barriers and enablers to the implementation of the intervention, inter-
views will be conducted amongst participants (n=6), and staff involved in referral 
and intervention delivery (n=6) (see process evaluation below). 
• Secondary objectives
• To identify a signal of efficacy for positive changes in physical health (exercise 
and nutrition), mental wellbeing, and quality of life (using tools described below) 
compared to usual care;
• To identify differences in DASI, length of hospital stay, complications and read-
mission rates to hospital following orthopaedic surgery (initially TKR and THR 
procedures) compared to usual care; 
• Assess surgeons’ and surgical practitioners’ willingness to refer to BoneFIt;
• Assess participants experiences of the BoneFit intervention; 
￼8

Sample Size and Process Evaluation:
Feasibility studies are typically unpowered, based on similar studies, we will aim 
to recruit 25 participants to the BoneFit intervention and 25 usual-care controls 
(n=50).  
A concurrent mixed methods process evaluation with explore safety, implementa-
tion, delivery, and acceptability of the intervention. We will use semi-structured 
interviews with participants and practitioners along with process data to assess:
• Barriers to recruitment;
• Acceptability and adherence to the intervention (dose received);
• Intervention delivery (fidelity);
• How the intervention was embedded into clinical practice;
•
Safety outcomes: will include adverse events and serious adverse events; 
•
We will collect quantitative process data on safety, screening and recruit-
ment, fidelity and dose/drop-out which will enable discussions with clinical 
teams to identify remedial actions to improve recruitment, retention, and 
fidelity. 
We will conduct a pilot feasibility study of the BoneFit intervention which will take 
approximately 3 years to complete (including all 12-month follow up visits).
Screening and Assessment for Exercise/Fitness/Functional Capacity:
Screening: We will use the Duke Activity Status Index (DASI) [7] to screen for re-
duced functional capacity. Patients with a DASI score > 34 are at low risk and will 
be assigned to universal support, those with a DASI score <34 will be referred for 
an assessment. 
￼9

Assessment: An incremental shuttle walk test (ISWT)[8] will be performed to assess 
patients"#functional capacity. Patients with ISWT distance of <475m will be assigned 
to targeted intervention. Patients with a ISWT distance of <400m or patients with 
a medical comorbidity that necessitates supervised exercise will be assigned to 
specialist intervention. If a patient is deemed unsuitable to complete the ISWT by 
the clinical supervisor due to functional limitations or progressive pain, we will ask 
them to just undertake a Timed Up and Go test and use this to screen into target-
ed (<18 seconds), or specialist groups (>=18 seconds). 
Screening and Assessment for Nutritional Status 
Screening: we will use the Malnutrition Universal Screening Tool (MUST score) [9] 
to identify patients at nutritional risk. If the patient scores <1 on the MUST score, 
they will be assigned to universal support. 
Assessment: Patients scoring >1 on MUST will be referred to a student dietitian for 
a nutrition assessment. This may result in the prescription of oral nutritional sup-
plements. This will include using the patient-generated and professional compo-
nent of the Patient-Generated Subjective Global Assessment (PG-SGA) [10]. They 
will additionally perform a hand grip strength test to enable a nutritional diagnosis 
and direct care in accordance with the Nutrition Care Process mode [11] and will 
be allocated to targeted or specialist groups accordingly. 
Screening and Assessment for Psychological Status: 
Screening: Patients will be screened using the General Anxiety Disorder Assessment 
(GAD-7) [12], the Patient Health Questionnaire 9 (PHQ-9) [13] and the $need for 
help"#emotions thermometer [14]. Patients scoring <9 on the GAD-7 or PHQ-9 and/
or <5 on the $need for help"#item of the emotions thermometer will be assigned to 
universal support. 
Assessment: Patients scoring >9 on the GAD-7 or PHQ-9, and/or >5 on the $need for 
help"#item of the emotions thermometer will be invited to speak to a student clini-
cal psychologist to determine targeted or specialist allocation. 
￼10

Based on initial screening, individuals will be categorised into a universal, targeted 
or specialist group and will receive an intervention based on the criteria identified 
in Table 2. Table 2. Personalised Care Plans Delivered based on Needs Assessment  
Universal
Targeted 
Specialist
￼11

Exercise
Home-based 
exercise 
(supported 
by regular 
phone/video 
calls with 
student phys-
ios/sports 
rehabilita-
tion thera-
pists);
Increasing 
frequency, 
intensity, and 
duration in-
crementally 
to achieve a 
minimum of 
150 min per 
week of 
moderate/
vigorous 
physical ac-
tivity (MVPA) 
In addition, 2 
sessions of 
resistance 
training per 
week. 
Sedentary 
time:replac-
ing daily sit-
tingtime with 
standing/
moving time.
Delivered by 
student 
physios/
sports 
rehabilitates 
group-based 
training (F2F 
- attend Hip-
Hub sports 
injuries clinic 
at UoH or 
delivered 
virtually 
through 
Teams).
3 sessions 
per week 
(total home 
and facility-
based 
sessions) of 
aerobic 
exercise 
training 
(minimum 20 
minutes per 
session)
(moderate or 
HIIT).
In addition, 2 
sessions of 
resistance 
training per 
week. 
Sedentary 
time:replac-
ing daily sit-
tingtime with 
standing/
moving time 
(use activity 
diaries)
Delivered 1:1 
in F2F Hip-
Hub setting.
3 sessions 
per week 
(including x1 
home 
session) 
aerobic 
training 
(minimum of 
20 min per 
session at 
moderate 
intensity.
Additionally, 
if able, 2 
resistance 
training 
sessions per 
week.
￼12

Nutrition
Dietary ad-
vice includ-
ing basic 
principles. 
Supported by 
regular 
phone calls / 
video calls 
with student 
nutritionists.
Dietetic/nu-
trition coun-
selling/ad-
vice with a 
student di-
etician, in-
cluding di-
etary modifi-
cation, man-
agement of 
nutrition im-
pact factors 
and oral nu-
tritional sup-
plements. 
This will be 
in addition to 
food fortifi-
cation advice 
as per best 
clinical prac-
tice. 
Artificial nu-
trition sup-
port recom-
mended by a 
dietitian as 
per best clin-
ical practice. 
EXCLUDED 
FROM INTER-
VENTION.
￼13

If an individual is identified as being in the Specialist group for Nutrition or Psycho-
logical Support they would be re-referred via HUTH for specialist care through usu-
Psychologic
al Support
Signposting 
to 
psychological 
support 
resources 
(such as 
relaxation 
and 
mindfulness 
apps) or as 
printed 
resources as 
appropriate. 
Supported by 
regular 
student-led 
phone/ video 
calls
Facilitated 
peer-group 
support em-
phasising 
mutual prob-
lem solving, 
plus a pack-
age of up to 
6 1:1 sessions 
with a stu-
dent clinical 
psychologist 
focus ing on 
self-regula-
tion of 
stress/anxi-
ety, self 
compassion 
and self-
soothing 
skills person-
alised to in-
dividual 
needs.This is 
consistent 
with typical 
level 2 psy-
chological 
support prac-
tice as per 
NICE Guid-
ance[64]. 
Full clinical 
psychological 
assessment 
and 
individualise
d 
intervention 
plan with a 
clinical 
psychologist(
or 
equivalent),a
s per best 
clinical 
practice andl 
Level 3/4 of 
NICE 
guidance 
[64]. 
EXCLUDED 
FROM 
INTERVENTIO
N
￼14

al professional service channels. Nutrition/dietetics/clinical psychology students 
would not be involved in their future care/treatment.  
• Theoretical/Conceptual Framework:
To maximise patient engagement and adherence a person-centred approach to be-
haviour change support will be employed across all components (exercise, nutri-
tion and psychological support) [15]. Students will be encouraged to use a motiva-
tional-type interviewing, and adopt the COM-B model of behaviour change [16]. We 
will focus on enhancing participants"#self-efficacy (confidence) to engage in new 
behaviours as well as developing strategies and action plans that meet their priori-
ties and personal circumstances. Approaches will be individualised depending on 
the level of patient autonomy required to adhere to the PCPs.
• Anticipated impact: 
BoneFit will benefit the NHS and patients in 4 ways: 1) informing clinical guidelines 
and developing the evidence-base around multimodal prehabilitation for patients 
requiring orthopaedic surgery; 2) improving local patient care and service delivery 
through enhancing equity of access to services and building on the principles re-
quired to deliver effective, safe services. Supporting patients who would benefit 
from optimisation of co-morbidities and needs-based multimodal PCPs, thereby 
helping them %wait well” for surgery; 3) identifying and delivering education, 
training and advocacy for student healthcare professionals; 4) local workforce 
transformation through informing the development of new service pathways. Fur-
ther funding from national (NIHR, MRC, orthopaedic charities) and local/regional 
sources will be sought if we can identify that the pathway is successful in terms of 
improving patient outcomes. 
Identification of participants:
Participants awaiting TKR/THR surgery will be provided with PIS V4 regarding Bon-
eFit during routine clinics at Castle Hill hospital. Contact details of the BoneFIt team 
are included and interested parties are encouraged to contact the team. Interested 
￼15

parties will be invited to the University of Hull for consenting, baseline assessments, 
and allocation to the intervention or control groups. Hull University Teaching Hospi-
tals Trust staff are only required to bring the trial to the attention of suitable patients 
at routine THR and TKR clinics and direct them to the participant information sheets. 
Interested parties should then contact the BoneFit team. 
Arrangements for the collection, use, sharing, security and integrity of participant 
data:
The BoneFit team at the University of Hull may require limited patient data from NHS 
organisations including Hull University Teaching Hospitals Trust. All data requested 
will be anonymised and each patient will receive a unique identification code. The 
University will only request data that is pertinent to the BoneFit intervention. For ex-
ample, details of psychological interventions undertaken as a consequence of Bone-
Fit screening into universal, targeted or specialist groups. Information requested for 
targeted interventions would include number of sessions undertaken, intervention 
details, and intervention outcomes following initial screening. NHS organisation could 
provide this information in the form of a brief summary statement and there is cer-
tainly no requirement for University staff to receive patient notes. This has been dis-
cussed with the Clinical Psychology team at HUTHT.
￼16

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