Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
Conditions: Chronic Pain, Fibromyalgia, Chronic Fatigue Syndrome, Chronic Low Back Pain
Sponsor: Pennine Acute Hospitals NHS Trust

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PROTOCOL  
 
Developing an activity pacing framework for the management of 
chronic pain/fatigue. Stage III: Feasibility and acceptability studies 
 
Version 2.1, 27.04.2018 
 
 
Funder:  
 
 
 
Health Education England/National Institute 
 
 
 
 
 
for Health Research (HEE/NIHR) 
 
 
 
 
 
Ref: ICA-CL-2015-01-019 
 
Sponsor:  
 
 
 
The Pennine Acute Hospitals NHS Trust 
 
 
Higher Educational Institute: 
School of Healthcare, University of Leeds 
 
 
Chief Investigator:  
 
Dr Deborah Antcliff  
 
 
 
 
 
The Pennine Acute Hospitals NHS Trust/ 
 
 
 
 
 
School of Healthcare, University of Leeds 
 
 
 
Co-investigators:  
 
Professor Linda McGowan 
 
 
 
 
 
School of Healthcare, University of Leeds 
 
 
 
 
 
 
 
 
 
Professor Philip Keeley 
 
 
 
 
 
Department of Health Sciences, University 
 
 
 
 
 
of Huddersfield  
 
Professor Anne-Maree Keenan 
NIHR Leeds Biomedical Research Centre 
(LBRC)  
 
 
 
 
 
School of Healthcare, University of Leeds 
 
 
 
 
 
 
Dr Malcolm Campbell 
 
 
 
 
 
Division of Nursing, Midwifery and Social 
 
 
 
 
 
Work, School of Health Sciences,  
 
 
 
 
 
University of Manchester 
 
 
 
 
 
 
Professor Steve Woby 
Research and Development Department, 
The Pennine Acute Hospitals NHS Trust 
and Salford Royal NHS Foundation Trust 

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Contents 
 
Page 
Abstract 
4 
1.0 INTRODUCTION 
 
6 
1.1 Background to the study 
6 
1.2 Our previous work 
7 
1.3 Conceptual framework 
9 
1.4 Purpose of the research 
9 
1.4.1 Aim 
9 
1.4.2 Objectives 
10 
1.4.3 Potential future benefits 
10 
1.5 Research question 
10 
2.0 METHODS 
11 
2.1 Study design 
11 
2.2 Stage III: Feasibility study 
14 
2.2.1 Sampling principles and procedures 
14 
2.2.1.1 Participants 
14 
2.2.1.2 Sample size 
15 
2.2.1.3 Recruitment 
15 
2.2.2 Rehabilitation programmes 
17 
2.2.3 Data collection methods 
19 
2.2.3.1 Outcome evaluation 
19 
2.2.3.2 Process evaluation 
24 
2.2.4 Data analysis 
24 
2.3 Stage III: Acceptability qualitative study 
25 
2.3.1 Sampling principles and procedures 
25 
2.3.1.1 Participants 
25 
2.3.1.2 Sample size 
25 
2.3.1.3 Recruitment 
26 
2.3.2 Data collection methods 
27 
        2.3.2.1 Outcome evaluation 
27 
        2.3.2.2 Process evaluation 
28 
2.3.3 Data analysis 
28 
2.4 Refining the activity pacing framework 
28 
3.0 ETHICAL AND REGULATORY CONSIDERATIONS 
31 
3.1 Assessment and management of risk 
31 
3.2 Benefits 
32 
3.3 Research Ethics Committee and other regulatory review and reports 
32 
3.4 Patient and public involvement 
32 
3.5 Data protection and patient confidentiality 
33 
3.6 Dropouts/Withdrawals 
34 
3.7 Indemnity 
34 
3.8 Costs/resources 
34 
3.9 Conflict of interest 
35 
4.0 WHAT HAPPENS AT THE END OF THE STUDY? 
36 
4.1 Dissemination/Publication 
36 
4.2 Future study 
36 
5.0 CONTACTS FOR QUERIES  
37 
6.0 TIMETABLE 
38 
References 
40 

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Page 
FIGURES 
 
Figure 1. Three-stage study to develop the activity pacing framework 
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Figure 2. Timetable of research activities 
39 
 
 
APPENDICES 
 
Appendix 1. Stage III: Feasibility study. Invitation letter for patients 
 
Appendix 2. Stage III: Feasibility study. Participant information sheet 
 
Appendix 3. Stage III: Feasibility study. Patient consent form 
 
Appendix 4. Activity Pacing Framework ‘Theory and Overview’ 
 
Appendix 5. Activity Pacing Framework ‘Appendices and Teaching 
Guide’ 
 
Appendix 6. Stage III: Feasibility study. Questionnaire booklet 
(T1_Post) 
 
Appendix 7. Stage III: Feasibility study. Questionnaire booklet 
(T1_Dept) 
 
Appendix 8. Stage III: Feasibility study. Questionnaire booklet (T2) 
 
Appendix 9. Stage III: Feasibility study. Questionnaire booklet (T3) 
 
Appendix 10. Stage III: Feasibility study. Covering letter for T3 
 
Appendix 11. Stage III: Feasibility study. Chief Investigator’s checklist 
 
Appendix 12. Stage III: Acceptability study. Invitation letter for patients 
 
Appendix 13. Stage III: Acceptability study. Participant information 
sheet for patients 
 
Appendix 14. Stage III: Acceptability study. Consent form for patients 
 
Appendix 15. Stage III: Acceptability study. Invitation letter/email for 
healthcare professionals 
 
Appendix 16. Stage III: Acceptability study. Participant information 
sheet for healthcare professionals 
 
Appendix 17. Stage III: Acceptability study. Consent form for 
healthcare professionals 
 
Appendix 18. Stage III: Acceptability study. Demographic questions for 
healthcare professionals 
 
Appendix 19. Stage III: Acceptability study. Outline for interviews. 
Patient version 
 
Appendix 20. Stage III: Acceptability study. Outline for interviews. 
Healthcare professional version 
 
 

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Developing an activity pacing framework for the management of chronic 
pain/fatigue.  
Stage III: Feasibility and acceptability studies 
Abstract 
Activity pacing is frequently advised in the management of chronic 
pain/fatigue, 
including 
chronic 
low 
back 
pain, 
chronic 
widespread 
pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis 
(CFS/ME). While chronic pain/fatigue is a common and debilitating problem, 
there is no agreed definition of ‘activity pacing’, the instructions of pacing vary 
across different healthcare services/professionals and there is no framework 
to ensure that the instructions of pacing are evidence-based. For some, 
pacing is interpreted as involving adapting/limiting activities (for example, 
breaking down tasks/using rest breaks); while for others, pacing involves 
having consistent activity levels/gradually increasing activities. Furthermore, 
previous research has found pacing to be associated with both improved 
symptoms (decreased fatigue, anxiety and depression) and worsened 
symptoms (increased pain and disability). 
 
Due to the frequent referral of patients with chronic pain/fatigue (20% of those 
frequently attending healthcare appointments/investigations), together with the 
cost of chronic pain/fatigue on patients’ quality of life and financial burden on 
the NHS/society (>£12,000 million per year for back pain alone), it is 
imperative that coping strategies such as pacing are clearly defined and 
based on evidence. 
 
This study involves the third stage of the development of an activity pacing 
framework to standardise how pacing is instructed by healthcare 
professionals. The first draft of the activity pacing framework was developed 
based on existing research, together with the findings from Stage I: 
Healthcare professionals’ survey. The activity pacing framework was further 
developed through undertaking a consensus meeting in Stage II: Nominal 
group technique, involving an expert panel of four patients and six healthcare 
professionals. Stage III: Feasibility and acceptability studies will test the 
activity pacing framework in the clinical setting. The framework will be used to 

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underpin five/six-week’s rehabilitation programmes for chronic pain/fatigue. 
The outcomes of the programme will be assessed using patient reported 
outcome measures of symptoms, self-efficacy and pacing; measured pre-
treatment, on the last week of the programme and at 3-months follow-up. The 
acceptability of the framework will be explored using semi-structured 
interviews with a purposive sample of the healthcare professionals and 
patients. It is envisaged that Stage III: Feasibility and acceptability studies will 
last 22 months. 
 
The pacing framework has the potential to improve treatments by providing 
guidance on the specific pacing components found to have benefits for 
patients and by standardising treatments that are based on a comprehensive 
and evidence-based framework. This study is funded by a Health Education 
England/National Institute for Health Research Integrated Clinical Academic 
(HEE/NIHR ICA) Clinical Lectureship (ICA-CL-2015-01-019). 
 

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1.0 INTRODUCTION 
1.1 Background to the study 
Patients with chronic pain/fatigue, including chronic low back pain, chronic 
widespread 
pain/fibromyalgia 
and 
chronic 
fatigue 
syndrome/myalgic 
encephalomyelitis (CFS/ME) are often referred to the healthcare services. 
These conditions contribute towards the 20% of patients who frequently 
attend secondary care (Reid et al., 2002). Chronic pain is estimated to affect 
approximately 28 million adults in the UK (Fayaz et al., 2016).  
 
The negative impact of chronic pain/fatigue can include disability, anxiety, 
depression and reduced quality of life (Clauw and Crofford, 2003; NICE, 
2007). These conditions place a heavy financial burden on healthcare 
services due to repeat referrals/investigations/treatments (Burton et al., 2012; 
Konnopka et al., 2013). In the UK, low back pain costs healthcare services 
over £1600 million, with indirect costs of over £10500 million (Maniadakis and 
Gray, 2000). Furthermore, there are indirect costs on the economy due to 
reduced employment/productivity; and loss of income and consequential 
emotional affects for the individual. A European survey across 243 
respondents with chronic pain in the UK found that 25% had lost their job due 
to pain, whilst a further 16% had changed their job responsibilities and 18% 
had changed their job completely. Furthermore, 24% had been diagnosed 
with depression as a consequence of their pain (Breivik et al., 2006). 
 
Healthcare professionals frequently advise patients with chronic pain/fatigue 
to implement activity pacing; considered a key facet of cognitive behavioural 
therapy and graded exercise therapy (Wallman et al., 2004; Beissner et al., 
2009). Despite anecdotal support and frequent recommendations of activity 
pacing, there is a paucity of empirical evidence (Andrews et al., 2012). Of the 
existing findings, pacing is associated with better symptoms, including: 
increased pain control, and decreased physical impairment, fatigue, anxiety 
and depression (Nielson et al., 2001; Murphy et al., 2010; Cane et al., 2013). 
However, pacing has also been associated with worsened symptoms: 
increased pain, avoidance and disability (McCracken and Samuel, 2007; 
Andrews et al., 2012). The mixed findings may be partly due to the absence of 

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pacing guidelines. For some, pacing involves reducing activities, for example, 
through slowing down, breaking down tasks and using rest breaks (White et 
al., 2007; Cane et al., 2013). Such facets of pacing may align with adaptive 
pacing therapy/energy conservation (White et al., 2007). For others, pacing 
involves planning, setting goals and gradually increasing activities (Sharpe, 
2002; Birkholtz et al., 2004; Nielson et al., 2013). Such strategies may align 
with the operant approach to pacing (Nielson et al., 2013). Therefore, different 
types of pacing are currently in existence, and it is stated in the NICE Clinical 
Guideline 53 (NICE, 2007) that activity pacing is advised with caution due to 
the current confusion regarding its effects. Due to the absence of a 
comprehensive, evidence-based pacing framework to standardise how it is 
instructed, 
patients, 
healthcare 
professionals 
and 
researchers 
may 
interpret/implement pacing differently.  
 
1.2 Our previous work 
This study builds on the research team’s previous work which developed an 
activity pacing questionnaire (APQ-26) (Antcliff et al., 2013; Antcliff et al., 
2015; Antcliff et al., 2016). Following factor analysis of the APQ-26, five 
themes of pacing emerged: activity adjustment (for example, breaking down 
tasks, using rest breaks and alternating activities), activity consistency 
(undertaking similar amounts of activity each day, including on ‘good’ and 
‘bad’ days), activity progression (gradually increasing activities), activity 
planning (assessing activity levels, setting time limits to avoid ‘overdoing’ 
activities and setting meaningful goals) and activity acceptance (adapting 
activity targets and being able to say ‘no’ to some activities). The APQ-26 
study found pacing to be a multidimensional strategy, in contrast to earlier 
research that found pacing to be a unidimensional concept (Kindermans et al., 
2011).  
 
Our previous work found that the different themes of pacing contained within 
the APQ-26 were associated with both better and worse symptoms among 
patients with chronic pain/fatigue (Antcliff et al., 2017). Specifically, among a 
sample of 257 patients with chronic pain/fatigue, regression analyses found 
that activity adjustment was significantly associated with worse symptoms: 

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increased 
physical 
fatigue 
(measured 
using 
the 
Chalder 
Fatigue 
Questionnaire), depression (measured using the Hospital Anxiety and 
Depression Scale) and avoidance (measured using the Pain Anxiety 
Symptoms Scale); and decreased physical function (measured using the 
Short Form-12) (all p≤0.03). Conversely, activity consistency was significantly 
associated with improved symptoms: decreased pain (measured using a 
Numerical Rating Scale), physical fatigue, depression and avoidance; and 
increased physical function (all p≤0.003). Activity planning was significantly 
associated with reduced physical fatigue (p=0.025) and activity acceptance 
was significantly associated with increased avoidance (p=0.036) (Antcliff et 
al., 2017).  
 
Since the above findings were cross-sectional and not causative, it is 
unknown whether the themes of pacing lead to the improved/worsened 
symptoms or whether the themes of pacing are implemented as a 
consequence to improved/worsened symptoms. In order to fully investigate 
the effects of pacing, a standardised pacing treatment is required. Currently, 
there is no comprehensive guide for healthcare professionals on how to 
instruct activity pacing in the clinical setting. 
 
We have developed an activity pacing framework for chronic pain/fatigue in 
Stages I and II of the present study. Stage I: Healthcare professionals’ survey, 
involved an online survey to explore opinions on activity pacing. Ninety-two 
healthcare professionals from across England were included in the data 
analysis, including physiotherapists (n=45), occupational therapists (n=30), 
clinical psychologists (n=7), nurses (n=4), doctors (n=4) and a cognitive 
behavioural therapist. The data from the survey, together with existing 
research evidence were used to develop the first draft of the activity pacing 
framework.  
 
The pacing framework was further developed in Stage II: Nominal group 
technique. This involved a consensus meeting to discuss the activity pacing 
framework across an expert panel of four patients with chronic pain/fatigue 
and six healthcare professionals (two physiotherapists, two occupational 

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therapists and two psychological wellbeing practitioners all based in the North 
West of England). The nominal group technique involved rounds of generating 
ideas and ranking the top 10 priorities of what needed to be included in the 
activity pacing framework and the corresponding appendices. For the 
framework, the priorities included a clear definition of pacing, the aims of 
pacing and providing the background to pacing behaviours. For the 
appendices, the priorities included explaining the stages of pacing, and 
describing other activity behaviours such as avoidance and boom-bust 
(overactivity-underactivity). Following the completion of Stages I and II, the 
current study involves Stage III to test the feasibility and acceptability of the 
framework. 
 
1.3 Conceptual framework 
The conceptual framework that underpins the current study will explore pacing 
as both a coping strategy (Nijs et al., 2008; Cane et al., 2013) and a behaviour 
(Kindermans et al., 2011; Nielson et al., 2013). As a coping strategy, pacing 
receives varying descriptions (as stated above). As a behaviour, the 
implementation of pacing may be determined by numerous factors. Factors 
that may lower rehabilitative health behaviours include increased symptoms 
such as pain, anxiety and depression (Schwarzer et al., 2011) and lower self-
efficacy (Jack et al., 2010). The implementation of pacing may align with 
conceptual models such as the Health Action Process Approach (HAPA) 
which conceptualises the uptake of health behaviours and behavioural 
change (Ogden, 2007; Schwarzer et al., 2008; Schwarzer et al., 2011). 
 
1.4 Purpose of the research 
1.4.1 Aim 
Despite the frequent use of activity pacing among patients with chronic 
pain/fatigue, pacing is instructed in varying ways and there are mixed findings 
regarding the associations between pacing and better/worse symptoms. We 
have developed a comprehensive activity pacing framework to standardise 
how pacing is instructed.  
 
 

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The aims of this study are: 
1.) Explore the feasibility of the newly developed activity pacing 
framework and facilitate the powering for a future pacing trial. In this study, 
‘feasibility’ refers to testing whether the pacing framework can be used to 
underpin rehabilitation programmes in the clinical setting. We are additionally 
assessing recruitment, attrition, the protocol, and whether the outcome 
measures that have been selected are appropriate to implement to assess the 
outcomes of pacing in a future trial. 
2.) Explore the acceptability of the newly developed activity pacing 
framework and compliance with the framework by healthcare professionals 
and patients. In this study, ‘acceptability’ refers to patients’ and healthcare 
professionals’ opinions on the rehabilitation programme underpinned by the 
framework. 
 
1.4.2 Objectives 
The secondary objectives of this study are: 
1.) Explore the associations between changes in pacing and changes 
in symptoms of chronic pain/fatigue, self-efficacy and quality of life. 
2.) Develop a comprehensive operational definition of pacing; and a 
conceptual model of pacing, both as a coping strategy and a behaviour. 
3.) Explore how pacing aligns with the Health Action Process Approach 
(HAPA) health behaviour model.  
 
1.4.3 Potential future benefits 
The development of a standardised activity pacing framework has the 
potential to clarify the instruction of the different facets of pacing and to enable 
future controlled clinical trials of pacing to add evidence regarding the effects 
of pacing on patients’ symptoms. 
 
1.5 Research questions 
1.) Is the newly developed activity pacing framework feasible and acceptable 
for clinical practice? 
2.) Is pacing associated with better or worse symptoms of chronic 
pain/fatigue?  

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2.0 METHODS 
2.1 Study design 
The Medical Research Council (MRC) describe complex interventions as 
interventions comprising of several interacting components (Craig et al., 
2008). Activity pacing is considered to be a complex intervention, involving 
different facets of pacing, which interact with factors including symptoms and 
behaviours. 
Complex 
interventions 
involve 
stages 
of 
development, 
feasibility/piloting, evaluating, reporting and implementing (Craig et al., 2008). 
Stage III of this study involves the feasibility/piloting stage the MRC complex 
intervention process. (See Figure 1: Three-stage study to develop the activity 
pacing framework.)1 The MRC advise a process evaluation of complex 
interventions to explore the fidelity and contextual factors that may influence 
the outcomes of the intervention (Moore et al., 2015). Stage III involves 
process evaluation in both the feasibility and acceptability studies.  
 
Stage III will have a mixed methods design: feasibility study with a repeated 
measures design (quantitative), and acceptability study (qualitative). The 
feasibility study will collect self-report questionnaire data pre-treatment, on the 
last week of a 5/6-week’s rehabilitation programme for chronic pain/fatigue 
and at 3-months follow-up. The activity pacing framework will be used to 
structure and standardise the instructions of pacing throughout the 
rehabilitation programme. Healthcare professionals (physiotherapists and 
psychological wellbeing practitioners) who deliver the programme will receive 
training in using the framework. The feasibility study will be used to assess 
patients’ changes in activity pacing, self-reported symptoms, self-efficacy and 
quality of life from those who consent.  
 
Since this study aims to test the feasibility of using the pacing framework and 
not compare between those attending the programme and those receiving a 
different intervention, there will be no control group. All patients will attend the 
same programme, including those who consent to the study and those who do 
                                                 
1This protocol refers only to Stage III: Feasibility and Acceptability studies 
 

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not. The pacing framework will be used to modify and standardise the pacing 
element of the rehabilitation programmes that usually run in the hospitals. 
Pacing is currently instructed as part of the programme, but at present, this is 
not standardised or based on evidence. The use of the framework is 
considered to be a service development to standardise the instructions of 
pacing and to ensure that the instructions are evidence-based. Therefore, all 
patients will receive the modified programme. However, those patients who do 
not consent to the study will not be asked to complete the study specific, 
repeated questionnaires. 
 
The acceptability study will explore opinions on the activity pacing framework 
using semi-structured interviews with the healthcare professionals delivering 
the rehabilitation programme and patients attending the programme. The 
acceptability study will also discuss how burdensome patients found the 
completion of the questionnaire booklets. 

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Stage III: Feasibility and 
acceptability of the pacing 
framework (CURRENT STUDY) 
Feasibility study 
Testing the pacing framework in 
rehabilitation programmes for chronic 
pain/fatigue. Psychometric measures 
taken pre-treatment and on the last 
week of the programme and 3-months 
follow-up. 
 
Acceptability study 
Exit interviews regarding the 
acceptability of the pacing framework 
with patients and healthcare 
professionals. 
Figure 1. Three-stage study to develop the activity pacing framework 
FUTURE STUDY 
Controlled trial using the pacing 
framework to explore the effects of 
pacing on symptoms.  
 
Cost analysis of pacing programmes. 
Stage I: Healthcare 
professionals’ survey 
(COMPLETED) 
Survey of current pacing 
interventions across multi-
disciplinary healthcare 
professionals in England (n=92). 
↓ 
Findings of the survey, together 
with the existing pacing literature 
(including a systematic 
review/narrative review) were used 
to develop draft 1 of the framework 
including an initial conceptual 
model and definition of pacing 
Stage II: Nominal group 
technique (NGT) (COMPLETED) 
 
Facilitated meeting to discuss draft 
1 of the pacing framework with 
patients (n=4) and healthcare 
professionals (n=6). 
 
↓ 
 
Draft 2 of the framework was 
developed based on the priorities 
that reached consensus in the NGT. 
 
 
Study underpinned by the MRC 
complex intervention framework 
exploratory stage. 
Further refine the pacing framework 
Development of the conceptual model 
for pacing commences in Stage I and 
continues throughout the study 

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2.2 Stage III: Feasibility study 
2.2.1 Sampling principles and procedures 
2.2.1.1 Participants 
Participants will include patients with conditions of chronic pain/fatigue 
attending rehabilitation programmes in physiotherapy departments of Fairfield 
General Hospital and North Manchester General Hospital (The Pennine Acute 
Hospitals NHS Trust). Five/six-week rehabilitation programmes currently run 
as part of usual treatment pathways for chronic pain/fatigue in these 
departments. Patients are currently referred to the physiotherapy departments 
with diagnoses of chronic pain/fatigue by a hospital consultant or a GP, and 
they are screened by physiotherapists ahead of referral into the rehabilitation 
programmes to ensure their main condition is that of chronic pain/fatigue (for 
example, chronic low back pain, chronic widespread pain, fibromyalgia and 
CFS/ME) and that they are appropriate for a group environment. 
 
Most patients who are referred to the rehabilitation programmes will be eligible 
to participate in the study due to the similar criteria for attending the 
programme. Patients’ eligibility to participate in the study can be further 
checked by the Chief Investigator using patients’ demographic data available 
in their physiotherapy notes, and by checking patients’ demographic answers 
in the study questionnaire booklet. The Chief Investigator is a physiotherapist 
based in The Pennine Acute Hospitals NHS Trust and is experienced in 
maintaining confidentiality of patients’ data when accessing patients’ medical 
notes. The inclusion and exclusion criteria for the study are as follows: 
 
Inclusion criteria: 
 Patients with an initial GP/hospital consultant referral to The Pennine 
Acute Hospitals NHS Trust with diagnoses of chronic low back pain, 
chronic widespread pain, fibromyalgia or CFS/ME, with a minimum 
symptom duration of 3 months. 
 Patients referred to a rehabilitation programme for chronic pain/fatigue 
 Patients aged ≥18 years 
 Patients able to read/write in English 

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Exclusion criteria: 
 Patients with evidence of a serious underlying pathology, such as a 
current diagnosis of cancer 
 Patients with severe mental health/cognitive functioning issues 
 
2.2.1.2 Sample size 
A sample size of 50 patients has been recommended for feasibility studies to 
enable estimates of attrition, compliance rates, means, standard deviations 
and differences between means with a suitable level of precision to facilitate 
future clinical trials (Sim and Lewis, 2012). 
 
2.2.1.3 Recruitment 
Participants will be recruited via consecutive sampling from those patients who 
are referred to the rehabilitation programmes in the physiotherapy 
departments. Patients’ eligibility to attend the rehabilitation programme will be 
screened by physiotherapists in the department to include patients with 
chronic pain/fatigue, and exclude those without the ability to read/write in 
English or those unsuitable for group rehabilitation (for example, those with 
agoraphobia). From the referral list into the rehabilitation programmes, the 
Chief Investigator can further check patients’ eligibility to participate in the 
study 
by 
checking 
patients’ 
physiotherapy 
notes 
against 
the 
inclusion/exclusion criteria. 
 
Patients who are enrolled on the rehabilitation programmes will be invited to 
participate via a postal letter one week before commencing the programme. 
Patients will be sent the participant information sheet, a consent form and the 
pre-treatment questionnaire booklet. Patients who consent to the study will be 
asked to complete the questionnaire booklet and consent form and return 
these in a pre-paid addressed envelope. In order to allow patients the 
opportunity to ask questions about the study and to increase recruitment, 
patients will also be reminded about the study and invited to participate on the 
first week of the rehabilitation programme. Patients who have not yet 
completed the questionnaire booklet/consent form from the postal invitation 
will have the opportunity to do this during the break time of the first session of 

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the programme (see Appendices 1, 2 and 3 for the participant invitation letter, 
participant information sheet and consent forms respectively). 
 
The application for ethical approval will include permission to gather basic 
demographic data (for example, age, gender, ethnicity, condition and duration 
of condition) from patients invited to participate but who do not consent to 
participating in the study to explore the representativeness of those recruited 
from those invited. (This information is also included in patients’ individual 
physiotherapy notes as per usual practice.) This basic data will be kept 
anonymous using unique study codes and it will remain confidential. These 
data will be inputted into a statistical package for data analysis. However, they 
will not be linked to patients’ identifiable information such as name, address, 
date of birth or NHS/department number. 
 
A minimum recruitment rate of 50% is estimated since patients will be advised 
that their participation involves only the completion of a questionnaire booklet 
at the beginning and end of treatment and at 3-months follow-up after finishing 
the programme. It is current practice in the physiotherapy departments for 
patients to complete questionnaire booklets at the beginning and end of the 
rehabilitation programmes, and so participating in the study will be an 
extension of this usual practice. Patients will be advised that their personal 
data will remain strictly confidential and anonymised during data analysis and 
any publication of the results. However, patients will have the option of not 
consenting, leading to the conservative estimate of a 50% recruitment rate.  
 
A completion rate of the rehabilitation programme of approximately 60% is 
expected based on current rates of the programmes running in the 
physiotherapy departments. The return rate of the 3-months follow-up 
questionnaire booklet is envisaged to be 50% based on recruitment rates into 
the previous APQ study (Antcliff et al., 2015). The estimated combined 
retention rate is 30%. Therefore, to achieve a sample size of approximately 50 
participants at 3-months follow-up who have both completed their rehabilitation 
programme and returned their follow-up questionnaires, 340 patients will be 
invited to participate. This number is feasible based on the approximate 380 

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patients referred to the programmes each year. The criteria for patients to be 
referred to the rehabilitation programmes is similar to that of the inclusion 
criteria for the study, therefore, the majority of the 380 patients referred into 
the group will be eligible to participate in the study. If more than 50 participants 
respond to the 3-month’s follow up questionnaire, these data will be included 
to maximise data analyses. 
 
Recruitment will occur from physiotherapy departments at two locations in The 
Pennine Acute Hospitals NHS Trust. Fairfield General Hospital runs 
approximately fourteen 6-week’s programmes each year with a maximum of 
12 participants per group. Recruitment will launch at this site first and recruit 
over a 15 month period (18 groups with 12 patients: n=216 invited to 
participate). Following the study set-up at Fairfield General Hospital, 
recruitment is envisaged to occur over a 12 month period from approximately 
fourteen 5/6-week’s rehabilitation programmes at North Manchester General 
Hospital with a maximum of 12 participants each group (14 groups with 12 
patients: n=168 invited to participate). Recruitment will occur over a 15-month 
period and data collection will occur over 20 months to allow for the 3-month 
follow-up questionnaire to be administered following the completion of the 5/6-
week’s programmes. To increase the follow-up return rate at 3-months, pre-
paid addressed envelopes will be provided and reminder phone calls will be 
made. (See Figure 2. Timetable of the study). 
 
2.2.3 Rehabilitation programmes 
Existing rehabilitation programmes 
Rehabilitation programmes currently run in two physiotherapy departments of 
The Pennine Acute Hospitals NHS Trust. These locations deliver similar 
programmes that consist of 3-3.5 hour sessions over 5/6 consecutive weeks. 
The programmes are delivered by healthcare professionals (physiotherapists 
and psychological wellbeing practitioners). The current programmes involve 
graded exercise, relaxation and discussion into coping strategies such as 
promoting healthy sleep behaviours, medication, balancing ‘choice’ and 
‘demand’ activities and activity pacing. Pacing is currently instructed during 
one session of the programme and these instructions are not standardised by 

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any specific framework. Pacing is referred to informally throughout the 
duration of the programme, for example, to assist patients’ approach to 
graded exercise. 
 
Activity pacing framework standardised programme 
The newly developed activity pacing framework will be used to structure and 
standardise the instructions of pacing across the 5/6-week’s rehabilitation 
programmes. The pacing framework clarifies the conceptual model of pacing 
on which the instructions are based. This pacing framework is underpinned by 
the operant approach of pacing rather than adaptive pacing therapy/energy 
conservation. The framework details the aims of pacing, different facets of 
pacing and contains tools/exemplars for healthcare professionals to assist 
their instruction of pacing to patients (see Appendices 4 and 5 for the Activity 
Pacing Framework ‘Theory and Overview’ and ‘Appendices and Teaching 
Guide’ respectively). In comparison to the existing rehabilitation programmes, 
pacing will be instructed on one session and revisited the following week. 
During this 1-week period, patients will be asked to complete an activity diary 
in order to discuss their activity patterns the following week. Pacing will be 
referenced throughout the programme in relation to the other coping 
strategies, since pacing principles apply to the use of relaxation and healthy 
sleeping 
behaviours. 
This is also advised 
in 
the activity pacing 
framework/appendices. Pacing is rarely implemented in isolation and so it will 
be explored in the current study as part of a programme alongside other 
coping strategies. This approach is similar to other pacing studies (Nielson 
and Jensen, 2004; Cane et al., 2013). 
 
The implementation of a standardised and evidence-based framework is 
considered to be a service development. The modifications will therefore be 
applied to all programmes across the different locations and all patients will 
attend the same programmes whether they choose to participate in the study 
or not. There is no harm envisaged through using the framework, rather, the 
framework aims to develop the current service by promoting more detailed 
and standardised information on activity pacing.  
 

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The healthcare professionals who usually deliver the programmes (n=8-10) 
will receive training on using the framework during a half-day session and they 
will also have regular contact with the Chief Investigator (face-to-face, or via 
the phone/email). Healthcare professionals will be advised that they can ask 
the Chief Investigator questions about the pacing framework at any time. The 
training will involve instructions on the different types of pacing and the model 
of pacing contained within the activity pacing framework. Healthcare 
professionals will be trained on the different facets of pacing and how these 
can be adapted and tailored to individuals according to their current activity 
behaviours and goals. The training will also involve practical issues around 
recruitment, administering consent forms/questionnaire booklets, and with 
regards to answering patients’ questions regarding the research study. 
 
No threats to patients’ health are anticipated through their participation, since 
patients routinely attend rehabilitation programmes for chronic pain/fatigue 
within these physiotherapy departments. Pacing currently features in the 
rehabilitation programmes, however, it is not currently advised based on an 
evidence-based framework, nor is it standardised across the healthcare 
professionals delivering the programmes. 
 
This study will not include a control group, since it aims to explore the 
feasibility of the protocol to assess the pacing framework in clinical settings, 
and not compare the effects of the programme against those not involved in a 
programme underpinned by the pacing framework. This is in keeping with the 
exploratory phase of the MRC framework for complex interventions. 
 
2.2.3 Data collection methods 
2.2.3.1 Outcome evaluation 
Participants will be invited to sign the study consent form and complete the pre-
treatment questionnaire booklet (T1). The T1 questionnaire booklet will be sent 
via the post one week before attending the programme (T1_Post). Those 
patients who did not sign the consent form and complete the T1 questionnaire 
booklet at home will also have the opportunity to do that during the break-time 
on week 1 of the programme (T1_Dept). Those patients not consenting to the 

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study will complete the usual department-required measures that are collected 
during Week 1 and 6 of the programme. The department-required measures are 
positioned at the front of the questionnaire booklet with a ‘tear away’ section for 
those questionnaires needed only for the research study. 
 
Patients will be invited to complete the post-treatment questionnaire booklet 
(T2) during the break-time of the last week of the programme in the 
physiotherapy department. The 3-months follow-up questionnaire booklet (T3) 
will be administered via the post. If no response is made to the follow-up 
questionnaire within two weeks, patients may be called to clarify any questions 
they have regarding the study, and to clarify whether they wish to continue to 
participate in the study through returning the T3 booklet. Alternatively, patients 
may be invited to answer some questions from the questionnaire booklet over 
the telephone. If patients consent to this, the priority questionnaires from the 
booklet will be asked, for example, regarding pain, pacing and health status. 
Prior to full data collection, the questionnaires have been piloted on three 
individuals not involved in the study to check the suitability of the layout, and the 
time and burden of completion. 
 
The T1 questionnaire booklet will contain demographic questions regarding 
age, gender, condition(s)/main condition, duration of condition, ethnicity, living 
situation (living alone/with others) and employment status; and the activity 
pacing questionnaire will be used as the measure of pacing. The 
questionnaire booklet will include validated measures of symptoms frequently 
reported by patients: pain, fatigue, anxiety and depression. The questionnaire 
will also assess self-efficacy as a driver for behavioural change, avoidance as 
a common behaviour presenting with this patient group, physical/mental 
function and health status. Many of the above constructs are important 
components of the HAPA behavioural model. 
 
1. Activity Pacing Questionnaire-28 
The Activity Pacing Questionnaire-26 (APQ-26) has been initially validated 
among a sample of patients with chronic pain/fatigue. Factor analysis 
identified five themes of pacing contained within the APQ-26. These five 

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themes 
demonstrated 
satisfactory 
internal 
consistency 
(Cronbach’s 
alpha=0.72-0.92; test-retest reliability intra-class correlation coefficient=0.50-
0.78, p≤0.001) and construct validity against validated psychometric 
measures (Antcliff et al., 2015). 
 
The APQ-26 has been modified for the purpose of this study with the addition 
of two items to correspond to important aspects of pacing that emerged during 
Stages I and II of the study and also appear in the literature regarding pacing. 
These two items involve finding a baseline of activities and being flexible. The 
APQ-28 reflects the content of the activity pacing framework.  
 
2.) 11-point numerical rating scale 
Two 11-point Numerical Rating Scales (NRS) will assess current pain and 
usual pain, where 0=‘no pain’ and 10=‘worst possible pain’ (Jensen et al., 
1994). The 11-point NRS are frequently used and have been found to have 
ease of completion, responsiveness and sensitivity to change in symptoms 
(Ferreira-Valente et al., 2011). 
 
3.) Patient Health Questionnaire 
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for 
and measure the severity of depression in the clinical setting. Items are 
developed based on the Diagnostic and Statistical Manual of Mental Disorders 
4th Edition (DSM-IV) (Kroenke et al., 2001). Each item is rated on a 4-point 
Likert scale (0-3) with a 2-week recall period. Scores of 1-4=no depression, 5-
9=mild 
depression, 
10-14=moderate 
depression 
and 
15-19=severe 
depression (Kroenke et al., 2001). The PHQ-9 has demonstrated good 
internal consistency (Cronbach’s alpha=0.86-0.89), test-retest reliability (0.84-
0.95) and construct validity against other measures of depression (Smarr and 
Keefer, 2011; Kroenke et al., 2001; Cameron et al., 2008). 
 
4.) Generalised Anxiety Disorder Assessment 
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items 
that screen for and measure the severity of anxiety in the clinical setting. The 
items are based on the Diagnostic and Statistical Manual of Mental Disorders 

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4th Edition (DSM-IV) (Spitzer et al., 2006). Items are rated on a 4-point Likert 
scale (0-3) over a 2-week recall period and cut-off scores of 5=mild anxiety, 
10=moderate anxiety and 15=severe anxiety (Spitzer et al., 2006). The GAD-7 
has demonstrated good reliability (Cronbach’s alpha=0.89-0.92), test-retest 
reliability (Intraclass correlation=0.83) and construct validity against other 
measures of anxiety (Spitzer et al., 2006; Lowe et al., 2008). 
 
5.) Pain Self-Efficacy Questionnaire 
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a 
persons’ confidence in their ability to do things despite their pain. Each item is 
rated on a scale from 0-6 where 0=not at all confident and 6=completely 
confident. Cut-off scores of PSEQ≥40 are considered high and PSEQ≤16 are 
considered low (Nicholas, 2007). The PSEQ has been found to have high 
internal consistency (Cronbach’s alpha=0.92), test-retest reliability (r=0.73, 
p<0.001) and construct validity against other measures of self-efficacy and 
other constructs (Nicholas, 2007; Miles et al., 2011). 
 
6.) Chalder Fatigue Questionnaire 
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical 
fatigue (seven items) and mental fatigue (four items). All items are rated on 4-
point Likert scale (0=‘better than usual’, 3=‘much worse than usual’) (Chalder 
et al., 1993). The scale has demonstrated good reliability and concurrent 
validity with regards to sensitivity and specificity (Chalder et al., 1993). 
 
7.) Pain Anxiety Symptoms Scale-short version 
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-
related fear, anxiety and avoidance and it contains four subscales: cognitive 
anxiety, escape/avoidance, fearful thoughts and physiological anxiety 
(McCracken and Dhingra, 2002). Each subscale contains five items; and 
items are rated on a 6-point Likert scale (0=‘never’ and 5=‘always’). The 
subscales of the PASS-20 have demonstrated good internal consistency and 
convergence validity with the PASS-40 (McCracken and Dhingra, 2002). 
 
 

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8.) 12-Item Short-Form Health Survey 
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that 
assesses physical and mental function (Ware et al., 1996). The 12 items are 
scored out of 100, where higher scores indicate better function. The SF-12 
correlates highly with the original 36-item survey and it has demonstrated test-
retest stability (Ware et al., 1996; Jenkinson et al., 1997). 
 
9.) EuroQol (EQ-5D-5L) 
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely 
used to assess both clinical and economic efficacy; and to compare health 
status across diseases (Brooks, 1996; Devlin and Brooks, 2017). The EQ-5D-
5L measures health related quality of life via dimensions of mobility, self-care, 
usual activities, pain and anxiety/depression (Devlin and Brooks, 2017). The 
EQ-5D-5L was developed to reduce the possible ceiling effects of the EQ-5D-
3L which contained only three levels of answers to each question (Devlin and 
Brooks, 2017). 
 
The T2 and T3 booklets will contain the same questionnaires, except without 
the demographic questions. The T2 booklet will additionally contain two 11-
point numerical rating scales (0-10) regarding satisfaction of the programme 
content and length. The T2 questionnaire booklet will also include a question 
inviting participants to indicate whether they would be interested in 
participating in the acceptability interviews (see Appendices 6, 7, 8 and 9 for 
the T1_Post, T1_Dept, T2 and T3 questionnaire booklets respectively; and 
Appendix 10 for the covering letter for T3). 
 
Participants will be asked to complete a 1-week activity diary after activity 
pacing is introduced in the rehabilitation programme. The diaries will be used 
the following week to assess patients’ patterns of behaviour, and to set goals 
towards pacing that are individualised. (See Appendix 5: Activity Pacing 
Framework ‘Appendices and Teaching Guide’ for the activity diaries.)  
 

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2.2.3.2 Process evaluation 
The Medical Research Council advise a process evaluation of complex 
interventions to explore the credibility of the findings and any confounding 
factors that may influence the outcomes (Moore et al., 2015). The process 
evaluation of the development of the activity pacing framework will include 
patients’ completion of NRS rating scales of satisfaction of the rehabilitation 
programme, and general comments that are made in the questionnaire 
booklets. The satisfaction ratings will assist the selection of participants for the 
next stage of the study: the acceptability interviews, which will discuss the 
programme in more detail. 
 
Healthcare professionals will be asked to complete a rehabilitation programme 
checklist to explore their compliance with the framework (see ‘Appendices and 
Teaching Guide’ Appendix 12 for the checklist). The Chief Investigator will 
meet healthcare professionals to ensure that there are no issues with 
delivering the activity pacing framework. Furthermore, the Chief Investigator 
will observe the rehabilitation programme at the different locations to monitor 
compliance with the study protocol and activity pacing framework. The Chief 
Investigator will be observing for a checklist of key points that are included in 
the delivery of the pacing framework in the rehabilitation programme (see 
Appendix 11 for the Chief Investigator’s checklist) 
 
2.2.4 Data analysis 
Descriptive statistics will summarise the demographics of the sample, and 
compare between patients who complete/do not complete the programmes 
and between the hospital locations. The feasibility study will not be powered 
to detect clinically important or statistically significant effects. Analysis will 
focus on estimating confidence intervals and effect sizes for differences in 
means or medians to inform the design of future trials, together with 
indicating likely recruitment/retention/compliance rates. The IBM SPSS 
Statistics 24 program will be used to analyse the data. 
 

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2.3 Stage III: Acceptability qualitative study 
2.3.1 Sampling principles and procedures 
2.3.1.1 Participants 
The acceptability of the pacing framework/rehabilitation programme will be 
discussed in semi-structured telephone interviews with a sample of the 
patients and healthcare professionals (physiotherapists and psychological 
wellbeing practitioners) who were involved in the feasibility study.  
 
Inclusion criteria: 
 Patients with an initial GP/hospital consultant referral to The Pennine 
Acute Hospitals NHS Trust with diagnoses of chronic low back pain, 
chronic widespread pain, fibromyalgia or CFS/ME, with a minimum 
symptom duration of 3 months (as per the feasibility study). 
 Patients who attended a minimum of the first two sessions of the 
rehabilitation programme, who consented to the study and completed 
the first questionnaire booklet. Patients do not need to have completed 
the programme, since the interviews will include patients who both 
completed and did not complete the programme. 
 Qualified 
healthcare 
professionals 
delivering 
the 
rehabilitation 
programmes who received training in using the activity pacing 
framework: physiotherapists and psychological wellbeing practitioners 
employed by The Pennine Acute Hospitals NHS Trust and Pennine 
Care NHS Foundation Trust. 
 
2.3.1.2 Sample size 
Patients and healthcare professionals participating in the feasibility study will 
be invited to participate in the interviews until there is a sample of 
approximately 15-20 patients and 6-8 healthcare professionals, or when data 
saturation is reached. Purposive sampling of patients will be undertaken to 
recruit 
patients 
with 
chronic 
low 
back 
pain, 
chronic 
widespread 
pain/fibromyalgia and CFS/ME; patients who were satisfied/unsatisfied with 
the programme (using the satisfaction scale in the T2 questionnaire booklet 
completed in the last week of the programme); and patients who did/did not 

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complete the programme. Used in this way, purposive sampling will enable 
wider discussions into both the favourable and less favourable opinions 
regarding the programme to enable the framework/programme to be further 
developed in the future. Purposive sampling with healthcare professionals will 
ensure that both physiotherapists and psychological wellbeing practitioners 
are invited to be interviewed. 
 
2.3.1.3 Recruitment 
Potential participants will be identified from those patients who tick the check 
box to agree to be contacted for an interview in the T2 questionnaire booklet 
(completed on the last week of treatment). In order to invite patients who did 
not complete the programme to participate in the interviews, patients who 
consented to the feasibility study, completed the first questionnaire (T1) and 
attended a minimum of the first two sessions of the programme will also be 
contacted. This will allow patients who did not complete the programme to 
discuss any barriers or challenges that arose. All patients, whether they 
completed the programme or not, will be invited to participate in the interviews 
over the telephone by the Chief Investigator. Patients who are interested in 
participating in the interviews will be sent a letter of invitation, an information 
sheet explaining the aims/nature of the interviews and that the interviews will 
be digitally recorded, together with a consent form (see Appendices 12, 13 
and 14 respectively). 
 
Healthcare professionals will be invited to participate in the interviews either in 
person, or via email/phone. They will be given an information sheet explaining 
the aims/nature of the interviews, and that the interviews will be digitally 
recorded (see Appendices 15 and 16). Healthcare professionals will be asked 
to sign and date the consent form and complete some basic demographic 
information (age, gender, profession and duration of expertise in chronic 
conditions) (see Appendices 17 and 18). 
 
Both patients and healthcare professionals will be asked to sign the consent 
forms and return them in pre-paid envelopes within one week. They may 
receive a telephone call if no contact has been made within one week to ask if 

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they still wish to participate in the interviews. They will also be asked to 
confirm their consent at the start of the audio-recorded interviews. 
 
2.3.2 Data collection methods 
2.3.2.1 Outcome evaluation 
The interviews with patients will be held once they have stopped attending 
physiotherapy: either through their completion or non-completion of the 
programme. It is therefore envisaged that the interviews will occur 
approximately two months after recruitment commences for the feasibility 
study (see Figure 2. Timetable of the study). Patients will be invited to 
participate in either telephone or face-to-face semi-structured interviews by 
the Chief Investigator (DA). Face-to-face interviews will be undertaken by the 
Chief Investigator (DA) in the physiotherapy departments or patients’ homes 
according to their preferences. If the interviews occur in patients’ homes, The 
Pennine Acute Hospitals NHS Trust lone-worker policy will be followed. The 
interviews will discuss the content of the programme, the information 
regarding pacing, patients’ opinions/experiences of pacing, the use of activity 
diaries and goal setting sheets, and the ease of completing the questionnaire 
booklets. Discussions will also involve identifying any potential barriers with 
attempting/committing to pacing, for example, symptoms or habits. 
 
The interviews with healthcare professionals will be held throughout the period 
of data collection for the feasibility study. Telephone or face-to-face semi-
structured interviews will be used according to healthcare professionals’ 
preferences and availability. Face-to-face interviews will be undertaken by the 
Chief Investigator (DA) and they will occur in the physiotherapy departments 
or healthcare professionals’ homes. The interviews will discuss the content 
and clarity of the framework and its usability in the clinical setting. The 
interviews will discuss any barriers to adherence with the pacing framework 
(for example, patients’ symptoms or practical issues). (See Appendices 19 
and 20 for the interview outlines for patients and healthcare professionals). 
The interviews with all participants are envisaged to last between 20-60 
minutes. Interviews will be digitally recorded and transcribed verbatim. Both 

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patients and healthcare professionals will be invited to read and check their 
own transcription for accuracy and invited to receive a report of the findings.  
 
2.3.2.2 Process evaluation 
Qualitative interviews are considered to be a useful method of process 
evaluation of complex interventions (Moore et al., 2015). The qualitative 
acceptability interviews will explore the fidelity of the feasibility stage with 
regards to adherence by both the patients and healthcare professionals to the 
activity pacing framework/rehabilitation programme. The interviews will help to 
identify possible contextual factors between patients/clinicians/locations/ 
number of sessions that may influence the findings. This process will assist 
the development of future studies that implement the pacing framework. 
 
2.3.3 Data analysis 
The qualitative data from the interview transcriptions will be analysed using 
Framework analysis. Framework analysis is a five-stage iterative matrix 
method, considered to be comprehensive and transparent, and allows for both 
inductive and deductive data analysis methods (Ritchie et al., 2003). The 
NVivo program (Version 11) will be used to manage the qualitative data.  
 
Data analysis commences during the undertaking of the interviews and the 
transcription, and continues during analysis of the transcriptions. The early 
commencement of data analysis during data collection/transcription facilitates 
the development of subsequent interviews and the detection of data 
saturation when no new concepts emerge (Morse and Field, 1996). Data 
analysis will be undertaken by the Chief Investigator working alongside a 
researcher (LMcG) with an expertise in qualitative research methods, together 
with two patients who are sitting on the study advisory panel.  
 
2.4 Refining the activity pacing framework 
Key findings from the feasibility and acceptability studies will be used to refine 
the pacing framework. Data from the feasibility and acceptability outcome 
evaluations will be synthesised using a seven-stage process in keeping with 
convergent mixed methods data analysis (Creswell and Piano-Clark, 2011). 

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This process will commence with separate data analyses of the feasibility 
questionnaire data and the qualitative interviews using quantitative and 
qualitative methods respectively. Key points for comparison between the 
quantitative and qualitative data will be determined. Once the data have been 
compared, the findings will be merged and interpreted. This synthesis of 
databases is beneficial to the validation of the findings through the 
triangulation of data from different sources (Creswell and Piano-Clark, 2011).  
 
The validity of the feasibility data will be limited since the sample size will be 
too small to infer statistical changes in pacing or symptoms. However, some 
patterns may arise in the quantitative data. The findings from the qualitative 
interviews may help to explain some patterns in the quantitative data. Findings 
from the synthesised data will help to refine the pacing framework and the 
definition/model of pacing. For example, it may emerge that some facets or 
aims of pacing are more frequently implemented or possibly mis-interpreted. 
Such elements may require a greater or lesser emphasis in the framework.  
 
The activity pacing framework will be further refined using the findings from 
the process evaluations. The process evaluations include the healthcare 
professionals’ checklist of compliance, Chief Investigators’ checklist of 
observations of the programme and feedback from the meetings with the 
healthcare professionals, together with aspects of the acceptability qualitative 
interviews (for example, regarding compliance/adherence). The process 
evaluation 
may 
bring 
to 
light 
practical 
problems 
of 
using 
the 
framework/appendices which can be modified to increase the usability of the 
framework. The process evaluation may also show differences in the 
programme 
delivery 
and 
adherence 
across 
different 
locations/ 
clinicians/duration of programme (five/six weeks); differing levels of 
acceptability across patients with different conditions; or possibly different 
changes in symptoms across different locations/conditions. Such findings 
could refine the framework through the acknowledgement of such potential 
differences/barriers 
and 
suggestions 
of 
methods to 
address 
these 
discrepancies. 
 

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The rate of attrition of the programmes, the completion of the questionnaire 
booklets (T1, T2 and T3), and the completion of activity diaries/goal setting 
sheets will be used to re-consider the format, length, burden and usability of 
these documents in the clinical setting. Information regarding attrition and 
compliance will help to modify the appendices and the questionnaire booklets 
to improve their usability in order to maximise recruitment and retention rates, 
and to improve the experience for patients and healthcare professionals in 
future studies. As a feasibility study, the purpose is to test the framework and 
methods of recruitment in order to prepare for a future clinical trial. 
 

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3.0 ETHICAL AND REGULATORY CONSIDERATIONS 
3.1 Assessment and management of risk 
It is not expected that participants will be at any risk from participating in the 
study. Patients’ participation in the feasibility study involves their completion of 
questionnaires at the beginning, end and at 3-months follow-up of their 
attendance of a rehabilitation programme. Rehabilitation programmes have 
been running in the physiotherapy departments at these sites for over a 
decade and the healthcare professionals running the groups are experienced 
in delivering these programmes. The activity pacing framework will 
standardise and structure the instructions of a coping strategy that is usually 
discussed in the programmes.  
 
Contained within the feasibility questionnaire booklet is a measure of 
depression (PHQ-9) which asks one question regarding suicidal ideation. If 
patients indicate that they have suicidal thoughts, this will be managed 
according to the usual risk pathway within the hospital sites. Patients will have 
access to the psychological team, step-up services/emergency telephone 
numbers or advised to attend the Emergency Department.  
 
During the acceptability interviews, no risk of harm is expected for either 
patients or healthcare professionals. The subject of the interviews: the activity 
pacing framework, is not considered to be sensitive or upsetting. However, if 
either the acceptability or feasibility studies have the potential to harm the 
well-being of an individual, they will be withdrawn from the study immediately 
and interviews will be stopped appropriately should sensitive/upsetting 
discussions arise. 
 
In the case of any adverse event, this will be documented following the usual 
protocol in The Pennine Acute Hospitals NHS Trust incident reports. The 
Research Ethics Committee will also be notified. 
 

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3.2 Benefits 
Participants will be advised that they may not receive any direct benefit from 
participating in the study. However, the information gathered from the study 
will contribute to the development of future practice and treatment. 
 
3.3 Research Ethics Committee (REC) and other regulatory review and 
reports 
The study will be conducted in accordance with the UK Policy Framework for 
Health and Social Care Research and other applicable guidance.  The study 
will not commence until all regulatory approvals are in place, which will include 
HRA approval, REC approval and confirmation from local R&D that the Trust/s 
have Capacity and Capability to carry out the research. 
 
The Chief Investigator will complete and submit annual progress reports to the 
Sponsor as requested and prior to submission to NHS REC, in accordance 
with the terms and condition of the study approval.  
 
The study will be subject to the standard procedures for monitoring and 
auditing of studies by the sponsor. 
 
Any changes to the protocol will be agreed with the sponsor prior to 
submission to NHS research ethics committee for review with the exception of 
where urgent safety measures apply.  
 
All staff working in the study will have completed appropriate training to 
undertake the duties delegated to them by the Principal investigator such an 
ICH-GCP. 
 
3.4 Patient and Public Involvement 
Patient and public involvement (PPI) commenced in the original development 
of the study to develop an activity pacing framework before Stages I and II. 
The current study is guided by a research team, together with an advisory 
team who comprise of two patients with chronic pain/fatigue and two 
clinicians. In the preparation of Stage III of the study, PPI have been involved 

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in commenting on the study documents, for example, patient information 
sheets, the activity pacing framework and questionnaire booklets. PPI will also 
be invited to work alongside the researchers during the qualitative data 
analysis from the acceptability interviews. 
 
3.5 Data protection and patient confidentiality 
In Stage III: Feasibility study, all patients will be identified using unique study 
codes. Healthcare professionals will also be identified using study codes so 
that their checklists can be collected anonymously. These study codes will be 
carried forwards for those who are involved in the Stage III. Acceptability 
interviews. 
 
Throughout the data analyses for the feasibility and acceptability studies, 
participants’ data will be identified by these unique codes on SPSS data files. 
Participants’ codes and personal data (such as addresses/telephone 
numbers) will be kept secure on a password protected Microsoft Excel 
worksheet housed in a password enabled and encrypted laptop, and on The 
Pennine Acute Hospitals NHS Trust secure network. This information is 
required to invite patients to complete the 3-months follow-up questionnaire 
and to participate in the acceptability interviews. 
 
The data will be stored for 10 years after data collection or the last publication, 
whichever date is the latter. This is with the exception of participants’ personal 
data which will be removed from the password enabled and encrypted laptop 
as soon as it is no longer required.  
 
Those patients who do not consent to the study will also be allocated a unique 
study code. However, no personal information regarding name, address, date 
of birth or NHS/department number will be stored on the Excel spreadsheet. 
Basic information from those patients who do not consent to the study, for 
example, age, main condition, ethnicity and duration of condition will be 
entered onto an SPSS data file to allow estimates of the representativeness of 
those patients who consent from all of those who attend the programme. 
These data will be anonymised using the unique study codes, and they will 

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not be linked to patients’ records or to information regarding their identifiable 
data. 
 
3.6 Dropouts/Withdrawals 
Participants will be advised that they are free to withdraw from the study at 
any point without explanation. Where possible, the reason for withdrawal will 
be recorded. Once participants have completed the feasibility or the 
acceptability study, they may be able to withdraw their data. However, 
participants will be advised that this will only be possible before data analysis 
has commenced (month 15) since data analysis will involve the convergence 
of data (see Figure 2. Timetable of research activities). 
 
3.7 Indemnity 
Participants will be advised that in the unlikely event that they feel they have 
been harmed by taking part in the research study due to negligence that they 
may have grounds for legal action against The Pennine Acute Hospitals NHS 
Trust. However, the participant may have to pay for any legal action. The 
normal Pennine Acute Hospitals NHS Trust complaints procedures and 
indemnity will apply. 
 
3.8 Costs/resources 
For Stage III: Feasibility study, no costs will occur to patients. They will attend 
rehabilitation programmes as per usual practice in the physiotherapy 
departments. For healthcare professionals, there will be a time requirement in 
order to undertake training in using the activity pacing framework (half a day) 
and follow-up meetings/telephone calls as needed with the Chief Investigator. 
The research costs include postage and printing to administer the 
questionnaires. 
 
For Stage III: Acceptability study, the costs/resources include the use of digital 
recorders, and printing/postage to send study information packs/consent 
forms and transcripts for checking. For participants, the cost will be their time 
to undertake the interview. For any face-to-face interviews, the Chief 

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35 
Investigator 
will 
travel 
to 
the 
participants’ 
nearest 
physiotherapy 
department/participants’ homes, according to their preferences. 
 
3.9 Conflict of interest 
The Chief Investigator (DA) will be involved in recruitment, data collection, 
data analysis and dissemination. To reduce bias, the Chief Investigator will 
not be responsible for delivering the rehabilitation programmes.  
 
The Chief Investigator, Dr Deborah Antcliff, is funded by an HEE/NIHR ICA 
Clinical Lectureship award (ICA-CL-2015-01-019). There is no conflict of 
interest. 
 

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36 
4.0 WHAT HAPPENS AT THE END OF THE STUDY? 
4.1 Dissemination/Publication 
Participants will be able to request a summary of the findings of the stage(s) 
of the study in which they were involved. The findings of the study will be 
disseminated as appropriate to patients/carers at patient forums/support 
groups (for example, CFS/ME and fibromyalgia support groups and the NIHR 
Leeds Biomedical Research Centre, LBRC, PPI group). The study outcomes 
will also be distributed via traditional media (newsletters), social media (for 
example, the LBRC webpage), presentations at national/international 
conferences and publication in national/international peer-reviewed journals. 
 
4.2 Future Study 
Following refinement in the present study, the activity pacing framework will 
be used in a clinical trial. The pacing framework will structure and standardise 
the instructions of pacing in rehabilitation programmes for patients with 
chronic pain/fatigue. Data regarding patients pacing behaviours, symptoms, 
function and quality of life will be collected pre- and post-treatment and at 3-
months follow-up in order to explore the effects of pacing on patients’ 
symptoms. The trial will also include the EuroQol (EQ-5D-5L) in order to 
estimate cost analyses of the treatment. The clinical trial will compare the 
outcomes from the programme underpinned by the pacing framework to a 
control arm that is not structured using the framework. Analyses will compare 
the efficacy of the framework-based programme, together with cost-
effectiveness. This future trial seeks to add data regarding the effects of 
pacing to add clarity to the current state of confusion regarding the possible 
benefits or ineffectiveness of pacing (White et al., 2011).   
 
Further research will develop and test a patient-friendly activity pacing guide 
based on the findings of the pacing trial. Future research will aim to validate 
both the pacing framework for healthcare professionals and the guide for 
patients across wider medical conditions, for example rheumatological 
conditions. 
 

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5.0 CONTACTS FOR QUERIES 
Participants will be advised that they are able to contact the Chief Investigator, 
Dr 
Deborah 
Antcliff 
(Senior 
Physiotherapist 
and 
Health 
Education 
England/National Institute for Health Research Integrated Clinical Academic 
(HEE/NIHR ICA) Clinical Lectureship researcher) throughout the study to ask 
questions. 
 
The contact details are:  
Deborah Antcliff 
 
 
 
 
(0161) 778 3882 
 
 
 
 
Deborah.Antcliff@nhs.net 
 
 
 
 
 
Physiotherapy Department 
Fairfield General Hospital 
The Pennine Acute Hospitals NHS Trust 
Rochdale Old Road 
Bury 
BL9 7TD 
 

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38 
6.0 TIMETABLE 
Key milestones:  
Project start: Ethical approval received and agreement with The Pennine 
Acute Hospitals NHS Trust Research and Development Department. 
Month 1:  
Feasibility study: train healthcare professionals in using the 
activity pacing framework (half-day training).  
Feasibility 
study: 
Begin 
contacting 
patients 
enrolled 
in 
rehabilitation programmes to invite them to participate (T1). Recruitment and 
T1 data collection will continue for 15 months. 
Month 2:  
Feasibility study: commence T2 data collection at the end of the 
5/6-week’s rehabilitation programme. T2 data collection will occur for 16 
months. 
Month 3: 
Acceptability study: Commence recruitment for semi-structured 
interviews. Conduct the interviews and analyse the qualitative data during 
data collection. Continue for 15 months or until data saturation is reached. 
Month 4:  
Feasibility study: 3-months follow-up (T3) data collection 
commences. Continue for 17 months or until a suitable sample size is reached 
(aiming for n=50) 
Month 15:  Feasibility study: data analysis of quantitative data and writing 
up the findings 
 
 
Acceptability study: write up the findings  
Month 16:  Refine the activity pacing framework  
Develop the pacing definition and conceptual model. 
(See Figure 2. Timetable of research activities)  
 
 
 
 
 
 
 
 
 
 

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Figure 2. Timetable of research activities 
Study duration:  
22 months 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 14 15 16 17 18 19 20 21 22 
Stage III. Feasibility study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train healthcare 
professionals using the 
framework 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient recruitment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
Data collection: questionnaire 
administration: T1 (initial)  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
Data collection: questionnaire 
administration of T2 (6 
weeks) 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Data collection: questionnaire 
administration of T3 (3 
months follow-up) 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Write up study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stage III. Acceptability 
study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Data collection (interviews) 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Data analysis 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Write up study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Refine pacing framework 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Develop pacing definition and 
conceptual model 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 

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