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10.1136/bmjopen-2024-084487
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Promotion of sports, exercise and physical activity participation during postoperative interventions for adolescent idiopathic scoliosis: protocol for an international e-Delphi study
https://twitter.com/MagowanSusanna
http://orcid.org/0000-0002-5224-8548
Tucker Susanna 12sxm1131@student.bham.ac.uk

https://twitter.com/HeneghanNicola
http://orcid.org/0000-0001-7599-3674
Heneghan Nicola R 1n.heneghan@bham.ac.uk

Gardner Adrian 3adrian.gardner@nhs.net

Russell Emily 4e.russell7@nhs.net

https://twitter.com/abrushton
http://orcid.org/0000-0001-8114-7669
Rushton Alison 5arushto3@uwo.ca

https://twitter.com/Andy_Soundy
http://orcid.org/0000-0002-5118-5872
Soundy Andrew 1a.a.soundy@bham.ac.uk

1 School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK
2 Physiotherapy Outpatients, Royal Orthopaedic Hospital, Birmingham, UK
3 Spinal Surgery, Royal Orthopaedic Hospital, Birmingham, UK
4 Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK
5 School of Physical Therapy, Western University Faculty of Health Sciences, London, Ontario, Canada
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

None declared.

SusannaTucker; sxm1131@student.bham.ac.uk
2024
20 9 2024
14 9 e08448719 1 2024
30 8 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Abstract

Introduction

Adolescent idiopathic scoliosis (AIS) is present in 2%–3% of those under 18 years old and has a significant impact on pain, function and quality of life. Up to 10% of adolescents with AIS progress to spinal fusion surgery, and of those individuals many experience reduced musculoskeletal function and do not return to sports postoperatively. Physiotherapists have a significant role in promoting participation and offering a graded return to sports, exercise and physical activity. However, there is a lack of evidence and variability between surgeons and physiotherapists worldwide regarding rehabilitation milestones and return to exercise, sports and physical activity. This study aims to reach a consensus on when it is safe and how an individual might begin a graded return to sports, exercise and physical activity.

Methods and analysis

This protocol was written in accordance with the Guidance on Conducting and REporting DElphi Studies (CREDES) guidelines. An international expert sample of surgeons and physiotherapists in AIS will be recruited. This electronic Delphi is anticipated to consist of three iterative rounds. Round 1 will be a series of open-ended questions examining rehabilitation milestones and return to sports, exercise and physical activity postoperatively. Round 2 will commence with a summary of the existing literature for participants to review. Rounds 2 and 3 will involve a collated summary of results from the previous round, including any dissonance. During rounds 2 and 3, participants will be asked to privately rate responses on a 5-point Likert scale. The study steering group and patient and public involvement representative have been involved from conceptualisation and will continue to be involved until final dissemination.

Ethics and dissemination

Full ethical approval has been provided by the University of Birmingham, reference number: ERN_1617-Nov2023. Dissemination will take place through conference presentation and peer-reviewed publications.

scoliosis
physical therapy modalities
paediatric orthopaedics
spine
Birmingham Orthopaedic Charity BOC3-Tucker
==== Body
pmcSTRENGTHS AND LIMITATIONS OF THIS STUDY

This international e-Delphi study will establish expert surgeon and physiotherapy consensus using inductive content analysis for the presence of themes, patterns or concepts and statistical testing to determine agreement and consensus in the group.

This study has been reported in accordance with Guidance on Conducting and REporting Delphi Studies guidelines as recommended by the Enhancing the QUAlity and Transparency Of Health Research network.

All methodological considerations were discussed and agreed on with patient and public involvement representative (ER) and the study steering group (AS, NRH, AG and AR).

All consenting eligible experts were able to participate regardless of whether they work part-time or only work with conservatively managed individuals.

Although, the literature supports both surgical and physiotherapy involvement in postoperative rehabilitation worldwide, different countries and jurisdictions may involve additional members of the multidisciplinary team beyond those recruited for this study.

Introduction

Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity present in approximately 2%–3% of the general population.1 2 These changes in back shape cause pain, reduced mobility, reduced pulmonary and cardiac function (for very large curves) and significant psychological distress.2 Typically, around 10% of individuals with AIS, with curves above 50° will go onto have spinal fusion, and biopsychosocial rehabilitation forms an essential part of recovery.37

Many individuals with AIS experience reduced musculoskeletal function, muscle power and range of motion postoperatively.8 Studies demonstrate 28.0%–36.6% of individuals choose lower impact activities postoperatively due to loss of flexibility, pain, fear and deconditioning.9 A recent retrospective study reported that of those who underwent surgery, 32.2% did not return to their preoperative activities due to stiffness or discouragement from their surgeon or parent.10 However, postoperative rehabilitation that encourages movement and activity can be effective in reducing ongoing disability, dissatisfaction, requirement for further operative intervention and reduced societal and economic costs.11 Both physiotherapists and surgeons need to be attentive to their patient’s thoughts, feelings and emotions towards their new back shape, as well as reintroduction of movement, sports, exercise or physical activity.4 11 Physiotherapeutic interventions are an essential means by which individuals return to function following spinal fusion, although the evidence to support a reduction in pain is limited.11 Furthermore, those with AIS often have specific and complex biopsychosocial needs, and therefore tailored guidance on postoperative interventions warrant specific care and attention.12

A key objective of physiotherapeutic rehabilitation is a return to function, along with restoring normal movement patterns and the promotion of self-management.13 14 Education and advice, sociological factors, exercise, physical activity, and in some cases sports participation, all form part of biopsychosocial rehabilitation in AIS.7 13 14 Preoperative rehabilitation, early mobilisation and conservative management have the literature to support their use.1519 Early mobilisation and exercise has been shown to improve outcomes and milestone achievement following spinal fusion.20 Furthermore, individuals with AIS who have participated in structured strengthening, flexibility and ambulation exercises preoperatively, along with early day 1 mobilisation and exercises postoperatively, have been shown to improve pain, recovery and an earlier hospital discharge, compared with those who underwent usual care.151821 22 However, following discharge from the acute setting, very little evidence exists to guide graded postoperative outpatient rehabilitation and milestones in return to sports, exercise and physical activity.9 11

Current physiotherapeutic outpatient postoperative rehabilitation in AIS is surgically guided with postoperative guidelines based on individual expert opinion.23 There is very little evidence regarding timing of return to sport and mixed expectations among medical professionals, patients and caregivers.10 There remains variability between surgeons worldwide regarding rehabilitation milestones, postoperative protocols and at what point it is necessary or safe to commence exercise and return to sports, exercise or physical activity following spinal fusion.24 Furthermore, there is a lack of consensus regarding which rehabilitation interventions are most effective alongside an array of biological, psychological and sociological adjuncts to care.192529 This lack of consensus between both surgeon and physiotherapy experts ranging from highly conservative immobilisation to early mobilisation and return to sports, exercise and physical activity results in a huge spectrum of different rehabilitation approaches among those involved in the management of AIS.24 This lack of clarity in rehabilitation results in some patients feeling fearful to move, participate in physical education classes at school, sports clubs with friends and ultimately lacking understanding regarding their care.24 Despite the International Society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) emphasis on the value, role and evolving nature of the wider multidisciplinary team (MDT) there remains limited MDT involvement with an absence of the literature regarding who ought to be involved in postoperative care in AIS.23 30 The focus of this project is global expert consensus on postoperative rehabilitation and return to sports, exercise and physical activity with literature supporting the involvement of both physiotherapists and surgeons. However, additional questions will be incorporated surrounding who else from the MDT ought to be involved in postoperative care.23

Aim

To determine surgeon and physiotherapy expert consensus on the rehabilitation milestones and philosophical approach taken in the return to sports, exercise and participation in physical activity for the postoperative care of those with AIS who have undergone spinal fusion surgery.

Objectives

To determine surgeon and physiotherapy expert consensus on timelines and milestones in returning to sports, exercise and physical activity participation in AIS.

To determine expert consensus on the components of MDT involvement and philosophical approach to postoperative rehabilitation interventions for AIS.

Methods and analysis

Study design

The study is reported in accordance with the Guidance on Conducting and REporting Delphi Studies guidelines recommended by the Enhancing the QUAlity and Transparency Of Health Research network.31 32 The Delphi method was chosen due to its ability to explore a topic of interest beyond current existing knowledge to achieve consensus.31 33 An electronic Delphi study (1) guarantees anonymity preventing factors such as dominant behaviour or peer pressure influencing results, (2) successive questionnaires allow iteration and controlled feedback keeping all participants informed of group opinion, while allowing participants to refine, comment on or amend their view working towards consensus, (3) rating of responses using Likert-type scales provides a statistical summary of the groups views and (4) improved content validity due to recruitment of experts representative of the target population and removal of geographical barriers.3436 The choice of experts will be based on their knowledge of AIS and their willingness to participate to help reduce the risk of unconsidered responses.34 Delphi studies allow the researcher to identify areas of agreement and variability with minimal bias, while also providing consensus in an area where there is an absence of empirical evidence.37

There remains debate among authors regarding which epistemological and ontological framework a Delphi sits within.33 For the purposes of this study, the decision was made to assume a pragmatist philosophical position. Pragmatism rejects the traditional notions of ontology and epistemology, instead focusing on solving real world problems within social constructivism.3840

Sample and expert eligibility

This e-Delphi survey will be distributed to a snowball sample of surgeon and physiotherapy experts working internationally within the management of AIS. This snowball sample is designed to aid recruitment of the target population of international experts and make use of established social networks to achieve greater participation than purposive sampling.41 Furthermore, social media snowballing has been shown to be successful, aiding the speed of recruitment and accessibility of potential participants.42 43

A sample of at least 20 surgeons and 20 physiotherapy experts from 2 populations will be recruited44:

Physiotherapy or surgeon academics with ≥2 publications on AIS, paediatric spinal pain or adolescent spinal pain in peer-reviewed journals in the last 10 years.

Clinical surgeon or physiotherapy experts with a caseload of ≥20% spinal deformity practice specifically in AIS (either conservative or operative) per month.

No exclusion criteria will be applied with regard to geographical location or cultural background.

Recruitment

Participants will be contacted and recruited via social media snowballing and professional networks within scoliosis, including Scoliosis Research Society, Scoliosis Association UK, National Scoliosis Foundation, British Scoliosis Society, Bundesverband Skoliose-Selbsthilfe, Vereniging van Scoliosepatiënten, Verein Skoliose Schweiz, Setting Scoliosis Straight and SOSORT.41 The survey will be sent electronically to individuals from a range of diverse backgrounds and a variety of geographical locations.31 45

Sample size

There is little consensus regarding sample size and sampling methods; however, if the group of participants is representative and knowledgeable in the area of interest, then content validity can be assumed.33 45 Recent Delphi studies evaluating expert surgeon, physiotherapy or specialist opinion on interventions have achieved consensus with 14−27 experts.4651 Therefore, in order to achieve consensus, it was estimated that a minimum of 27 experts are required. Due to an estimated response rate of 70%, a minimum of 40 consenting experts (20 surgeons and 20 physiotherapy experts) will be recruited to this study.33 To help reduce risk of dropout, experts chosen will be willing and informed individuals who have interest and subject specific knowledge rather than through monetary reward.3745 5254

Procedure

This e-Delphi study will have an iterative process comprising three rounds. Figure 1 shows a summary of the e-Delphi rounds.

Figure 1 Stages of Delphi procedure. AIS, adolescent idiopathic scoliosis.

Prior to round 1, the study will be pilot tested with a small group of individuals who will not be participating in the final e-Delphi study. Pilot testing will be completed from a tertiary hospital specialising in the care of those with AIS to ensure that both the wording of the survey, timing for completion and the administration are feasible.45 To improve feasibility, ease and use of the survey, all three rounds will be piloted.45 All rounds of this e-Delphi will be completed using Research Electronic Data Capture (REDCap) software for electronically distributing and collecting survey data.55 56 The study begun in February 2024 with final data collection completed by September 2024.

Round 1

Aim

The aim of round 1 is to generate a broad series of statements on the rehabilitation interventions, milestones and philosophical approaches used in AIS.

Procedure

Following the pilot study, prior to e-Delphi survey distribution, a discussion among study steering group (AS, NRH, AG, AR) and patient and public involvement (PPI) representative (ER) will be completed.57 58 During round 1 individuals will be asked a series of open-ended questions and asked to anonymously express their views with freedom in responses.36 59 Data will be gathered on the individual’s geographical location, percentage of spinal deformity practice and nature of either clinical or academic work. Round 1 acts as an idea generation round, with participants identifying a wide range of issues related to the topic.45 Open-ended questions will be designed to allow participants freedom in their responses.45 Open-ended questions during round 1 will be informed by an extensive literature review.7 However, no supplementary material will be introduced during round 1 to reduce bias.60

During round 1, participants will be asked for at least six opinions in response to certain key questions, as many individuals are likely to repeatedly raise the same issue.59 However, the number of questions asked will be few to allow recirculation of all data in round 2 helping to avoid bias.57

Data analysis

Data will be analysed using inductive content analysis for the presence of themes, patterns or concepts.6163 All results will be verified by a second researcher (AS) to ensure data is represented fairly.59 Areas of dissonance among the group will be determined and highlighted in round 2 in an attempt to move towards whole group consensus.59 64 Dissonance will be defined as opposing viewpoints needing clarification and definition of different opinions.65 Reducing and redistributing statements for feedback during round 2 has been previously demonstrated within scoliosis and ensures that data does not become biased or too far removed from original verbatim statements, while helping the group move towards consensus.19 59 Data on participant characteristics, including location and volume or nature of work, will also be tabulated to aid analysis of results and illustrate any potential confounders or mediators in results analysis.

Consensus

During round 1, consensus is defined as agreement>1. Therefore, only responses with agreement>1 between two or more participants will be redistributed, helping to reduce participant drop out due to the length of the questionnaire.45 60

Progression to subsequent round

A summary of qualitative comments will be included following discussion with the study steering group.31 Items not progressed to round 2 will be visible to the reader in an online supplemental appendix and form part of the final discussion in order to reduce bias.45 The study steering group will be involved in reviewing all the data and decision-making regarding which statements will proceed into round 2. Following round 1, the theoretical framework will be determined based on the responses given.

Round 2

Aim

The aim of round 2 is to continue moving the group towards consensus by allowing participants the opportunity to review, revise and privately rate responses.35

Procedure

All consenting participants will be invited to round 2 including those who did not complete round 1, to help reduce the risk of false consensus.66 Ideas and statements generated during round 1 will be redistributed during round 2. Any dissonance between physiotherapy and surgeon experts during round 1 will also be collated, summarised and redistributed for further consideration and feedback.

Participants will be invited to reconsider all responses, with agreement >1, from round 1 and then rate their agreement with statements using a 5-point Likert scale, 1=strongly disagree, 5=strongly agree. Despite the debate in the literature, a 5-point Likert scale was determined to be both quick and easy while also giving reliable results.67 Participants will also be given the opportunity to offer their opinion on the issues raised during round 1 in an open text box.45 57

Information provided

At the start of round 2, participants will be given a summary of the results from the previous round and a summary of the current literature on factors that influence participation in sports, exercise and physical activity in paediatric spinal pain, to aid consensus.7 31 45 There is support for inclusion of pre-existing literature, such as a systematic review, prior to the participant rating of responses to promote efficiency in a methodology that has the potential to be very time-consuming.31 45 59 Although, introduction of pre-existing information may prove to be a source of bias, by introducing literature published ‘open access’ participants are guided towards the topic of interest and efficiency promoted.45 57 68 This seeded approach, using pre-existing literature, allows the researcher to further explore the secondary objective of the study (factors that influence participation in sports, exercise in physical activity in AIS) by giving experts the opportunity to comment on the previous literature in a widely under-researched area.69 Meanwhile, the seeded approach still achieves expert consensus with opportunity to volunteer data items that are non-existent in the current literature in an unbiased environment.69

Data analysis

Likert numerical data from rounds 2 and 3 will be quantitatively analysed using descriptive and inferential statistics.59 Statements rated either agree or strongly agree will be used to calculate a percentage to evaluate consensus.57 Central tendencies of rated items (median) will be displayed, producing a statistical summary of each item and their dispersion (IQR).59 65 Due to the nature of a Likert ordinal scale, it is not possible to demonstrate standard deviation.70 The report of central tendency will allow participants to see their responses from round 2 in a statistical relation to other responses to make decisions on rerating items in round 3, while simultaneously achieving a non-biased consensus.59 Stability of consensus will be calculated for both round 2 and 3.58 During each round, participants will be given the opportunity for open responses. Any open-ended responses that have agreement across >1 participant will again be grouped and summarised for inclusion in round 3 once verified by the second researcher (AS).31 59 65

Definition of consensus

Consensus during round 2 will be determined when >75% participants within the group agree with a statement.64

Progression to subsequent round

When a statement achieves consensus during round 2, it may then proceed into round 3.

Round 3

Aim

The aim of round 3 will be to determine consensus on postoperative physiotherapeutic interventions following spinal fusion for AIS.

Procedure

Summary data including descriptive and inferential statistics, dissonance and stability58 59 will again be sent to all consenting participants. Those who have withdrawn, regardless of their central tendency or dispersion, will be excluded.36 The same Likert scale will be used in round 3 to rate responses to help reduce the volume of data towards consensus.59

Participants will again be asked to rate their agreement with the statements that achieved >75% agreement during round 2, using the same 5-point Likert scale but with an additional opportunity for open comments.

Information provided

Participants will again be provided with a summary of the results from round 2 and areas of dissonance will be identified.

Data analysis

Kendall’s coefficient of concordance will be used to evaluate agreement between statements from round 3 and determine consensus, with value items at 0 indicating weak association and 1 indicating strong association.70 Response ratings for all three rounds will be reported to aid credibility and validity of results, and areas of dissonance will be discussed.71 Stability between rounds 2 and 3 will be calculated using a Wilcoxon rank-sum test with significance at p<0.05.65 72 73 Data will then be tabulated and presented with a visual summary of results and consensus on postoperative interventions for return to sports, exercise and physical activity.

Definition of consensus

For the purposes of this study, it was determined that consensus would be achieved when Kendall’s coefficient≥0.7.7477 Stability will aid determination of the internal reliability of statements and the stability of the consensus.57 58

Definition of consensus, agreement and stability

During each round, consensus, agreement and stability will be assessed (table 1). Consensus does not equate with ‘the correct answer’ but rather that the group of expert participants are in agreement regarding the topic of interest.33 For the purposes of this study, and due to the predefined expected number of Delphi rounds and inconclusive definition of consensus in the literature, consensus was used determined dependent on level of agreement between participants.57 Due to the nature of a Delphi study, it is expected that the level of agreement will increase as experts progress from round 2 to round 3.70

Table 1 Definitions

Item	Definition	
Stability across all rounds	Consistency of responses and presence of consensus for each statement between Delphi rounds 2 and 3 using a Wilcoxon sum-rank test.57 65 73	
Agreement	The level of agreement between expert participants as demonstrated by the percentage, thereby enabling us to predict the rating of another expert.65	
Consensus round 1	Agreement>1 participant for statements made.	
Consensus round 2	Level of agreement≥75% between participants for each statement.	
Consensus round 3	Kendall’s coefficient of concordance=0.77477	

Data management

The three rounds of this e-Delphi study are summarised in figure 1. Participants will not meet directly during this study but will be sent online questionnaires seeking views on the topic of interest.36 The survey and data will be distributed, collected, stored and analysed electronically using REDCap.56 REDCap is a secure online software that is designed for creating and managing online surveys.78 All data will be securely stored using REDCap on a password-protected computer with members of the research team only having access to the data. Following completion of the study, data will be securely stored within the University of Birmingham (UoB) for 10 years, following which it will be safely destroyed in accordance with the UoB guidelines.

Study steering group

Coauthors (AS, NRH, AG and AR) constitute the study steering group, comprising methodological, academic expertise and clinical expertise in physiotherapy and spinal surgery. The group will meet to discuss the analysis of the results from each round and iteration in the subsequent round and to provide feedback and critical insights on the progress of the project.

Patient and public involvement (PPI)

A PPI representative (ER) has been involved from study conceptualisation and will continue to be until final dissemination. Both clinicians and academics working within the field of AIS, as well as PPI representative (ER), will be involved in making research decisions and giving feedback regarding methodology and results synthesis at all stages of the process. To further promote transparency and consistency of PPI reporting the Guidance for Reporting Involvement of Patients and the Public Short Form Checklist will be used online supplemental file 1.79

Discussion

There is an absence of literature regarding postoperative rehabilitation following spinal fusion in AIS. Physiotherapeutic interventions for conservative management and preoperative care in AIS are mixed and varied, supported by a large body of the literature. The literature supports the use of preoperative exercise and postoperative psychological interventions to improve postsurgical pain, anxiety, quality of life and satisfaction.19 80 However, the content and milestones for physiotherapeutic rehabilitation and return to sports, exercise and physical activity postoperatively in AIS lacks consensus among physiotherapists, surgeons and the wider MDT.9 This lack of consensus has resulted in patient confusion regarding their expectations in care and fear avoidance of movement, physical education classes and sports clubs.24 Consensus on when it is safe to commence sports, exercise and physical activity postoperatively, the timing of rehabilitation milestones and the involvement of a biopsychosocial approach will help move towards consistency and clarity in postoperative care offered.24 30

Delphi studies have been shown as beneficial in achieving expert consensus in the health sector.59 Importantly, consensus does not mean the correct answer, but instead that agreement has been reached.31 33 Conversely, the presence of non-consensus also requires critical reflection rather than dismissal due to its ability to offer insight and difference of perspective on complex issues.31 There are a number of strengths to this e-Delphi methodology. Although, the anonymity of respondents in this e-Delphi study may risk unconsidered responses from some participants, it helps to promote honesty, prevents bias and prevents participants feeling pressured or mocked for their responses.34 45 Furthermore, anonymity of experts, controlled feedback in subsequent rounds, multistage iterations and exploration of consensus, all enhance the validity and reliability thereby improving the quality of responses.33 81 The choice of an electronic international survey for this study allows information to be exchanged between individuals who are geographically dispersed through an iterative process.36 Rating of responses was chosen rather than ranking due to the ability to discriminate between items of moderate importance and its perceived ease of use when compared with ranking.82

Due to the multiple and varied rehabilitation approaches offered for patients following spinal fusion in AIS, this e-Delphi study will be valuable in gaining expert consensus on what postoperative rehabilitation ought to consist of.10 24 Although, there are limited examples of using Delphi to develop clinical guidelines.59 Consensus obtained from this study will be valuable in formulating future pilot or feasibility testing of novel physiotherapeutic rehabilitation interventions for postoperative rehabilitation in AIS.33 36 45 59 A further risk in this e-Delphi is limited generalisation due to the dependence on individuals participating or the time point during which it was completed.37 To try and minimise the risks of limited generalisation this e-Delphi will be distributed to all consenting eligible experts.

Ethics and dissemination

Full ethical approval has been provided by the UoB, reference number: ERN_1617-Nov2023. Dissemination will take place through conference presentation and peer-reviewed publications.

supplementary material

10.1136/bmjopen-2024-084487 online supplemental file 1

10.1136/bmjopen-2024-084487 online supplemental file 2

Review Process File
20 09 2024

Funding: The work has received funding from the Birmingham Orthopaedic Charity (grant number BOC3-Tucker). Support was given from the UoB School of Sport Exercise and Rehabilitation Sciences.

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-084487).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods and analysis section for further details.
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