Sedentary Time in Individuals With Ischaemic Heart Disease and Its Association With Cardiac Function, Structure and Cardiovascular Risk Factors
Conditions: Cardiovascular Diseases, Sedentary Behavior
Sponsor: University of Bedfordshire

 
i 
 
 
 
 
 
FULL/LONG TITLE OF THE STUDY 
Sedentary time in individuals with ischaemic heart disease and its association 
with cardiac function, structure and cardiovascular risk factors.  
 
SHORT STUDY TITLE / ACRONYM 
• Sedentary time cardiovascular risk factor associations in IHD  
 
PROTOCOL VERSION NUMBER AND DATE 
• 
V11.0/ 02Dec22 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 
312557 
SPONSORS Number: 
N/A 
FUNDERS Number: 
N/A 
 
 
 

Sedentary time and IHD 
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SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
...................................................................................................... 
 
 
Position: 
...................................................................................................... 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
....../....../...... 
Name: (please print): 
......................................................................................................
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Sedentary time and IHD 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE  
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS  
iv 
KEY STUDY CONTACTS 
v 
STUDY SUMMARY 
v 
FUNDING 
 
vi 
ROLE OF SPONSOR AND FUNDER 
vi 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
vi 
STUDY FLOW CHART 
 
vii 
SECTION  
1. BACKGROUND 
 
1 
2. RATIONALE 
 
 
3. THEORETICAL FRAMEWORK 
 
4. RESEARCH QUESTION/AIM(S)  
 
5. STUDY DESIGN/METHODS 
 
6. STUDY SETTING 
 
7. SAMPLE AND RECRUITMENT 
 
8. ETHICAL AND REGULATORY COMPLIANCE 
 
9. DISSEMINATION  POLICY 
 
10. REFERENCES 
 
11. APPENDICES 
 
 
 

Sedentary time and IHD 
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KEY STUDY CONTACTS 
 
Chief Investigator 
Dr Joanna Richards 
Institute for Sport and Physical Activity Research 
University of Bedfordshire 
Polhill Avenue 
Bedford 
MK41 9EA 
Email: jo.richards@beds.ac.uk 
Study Co-ordinator 
Abbie Bell 
PhD Student  
Institute for Sport and Physical Activity Research 
University of Bedfordshire 
Polhill Avenue 
Bedford 
MK41 9EA 
Tel: 07984545911 
Email: abbie.Bell@study.beds.ac.uk 
Sponsor 
University of Bedfordshire 
Polhill Avenue 
Bedford 
MK41 9EA 
Funder(s) 
N/A 
Key Protocol Contributors 
Abbie Bell, PhD Student  
Institute for Sport and Physical Activity Research 
Abbie.Bell@study.beds.ac.uk 

Sedentary time and IHD 
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Committees 
N/A 
 
STUDY SUMMARY 
Study Title 
Sedentary time in individuals with ischaemic heart disease 
and its association with cardiac function, structure and 
cardiovascular risk factors.  
Internal ref. no. (or short title) 
Sedentary time and cardiovascular risk factors in IHD  
Study Design 
Cross-sectional 
Study Participants 
Ischaemic heart disease patients  
Planned Size of Sample (if applicable) 67 
Follow up duration (if applicable) 
7 days 
Planned Study Period 
7 days 
Research Question/Aim(s) 
 
What is the sedentary pattern of individuals with ischaemic 
heart disease and its association with cardiac function and 
cardiovascular risk factors?  
 
 
ROLE OF STUDY SPONSOR AND FUNDER 
The Sponsor of this study is the University of Bedfordshire. The sponsor is responsible for the overall 
conduct and management of the study  
There is no external funder for this study. 
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
Cardiac Rehabilitation Team at Bedford Hospital 
Regular meetings will be held between the Bedford Hospital Cardiac Rehabilitation team and the study 
investigators to discuss how to conduct the study in terms of participant recruitment, data collection and 
dissemination.  
 
 
 

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PROTOCOL CONTRIBUTORS 
Abbie Bell 
PhD Student  
Institute for Sport and Physical Activity Research 
Responsibilities: Study design, study conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results. 
 
Dr Joanna Richards 
Director of Studies 
Institute for Sport and Physical Activity Research 
Responsibilities: Overview of study design, conduct, data analysis and interpretation, manuscript writing, 
and dissemination of results 
 
Dr Julia Fruer 
Second Supervisor 
Institute for Sport and Physical Activity Research 
Responsibilities: Overview of study design, conduct, data analysis and interpretation, manuscript writing, 
and dissemination of results 
 
Dr Lindsey Smith 
Third Supervisor 
Institute for Sport and Physical Activity Research 
Responsibilities: Overview of study design, conduct, data analysis and interpretation, manuscript writing, 
and dissemination of results 
 
Dr Daniel Bailey 
External Advisor 
Brunel University, London 

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Responsibilities: Overview of study design, conduct, data analysis and interpretation, manuscript writing, 
and dissemination of results.  
 
KEY WORDS: 
Ischaemic heart disease (IHD), Coronary artery 
bypass graft (CABG), Post- myocardial infarction 
(post-MI), Cardiac Rehabilitation (CR), sedentary 
behavior, cardiometabolic risk 
  
 
 
 

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STUDY PROTOCOL 
 
1 
BACKGROUND 
Cardiovascular Disease (CVD) is the leading cause of mortality and morbidity globally (World Health 
Organization, 2019). In the UK alone, it was accountable for 124,641 deaths in 2017. Further to this, 
CVD contributes to a vast economic burden, costing the National Health Service (NHS) £19 billion 
annually. This is mainly due to a significant number of hospital readmissions following a first cardiac 
event (198,000 per annum) (British Heart Foundation, 2018).  
Cardiac Rehabilitation (CR) is a secondary preventative measure to further cardiac events. The British 
Association of Cardiovascular Prevention and Rehabilitation (BACPR) defines CR as ‘the coordinated 
sum of activities required to influence favourably the underlying cause of cardiovascular disease, as well 
as to provide the best possible physical, mental and social conditions, so that the patients may, by their 
own efforts, preserve or resume optimal functioning in their community and through improved health 
behaviour, slow or reverse progression of disease’. It is suggested by the National Institute for Health 
and Care Excellence (NICE) that all patients should be offered a CR programme with an exercise 
component following an MI (BACPR., 2017). There is conflicting evidence regarding the benefits of 
exercise-based CR upon cardiovascular mortality and morbidity, hospital readmissions and all-cause 
mortality. Previously, CR has been shown to be beneficial in longer term health outcomes of cardiac 
patients. The 2016 Cochrane Review of Exercise based CR found that, when compared with a no 
exercise control group, exercise-based CR accounts for an estimated risk reduction of 26% and 18% 
for cardiovascular mortality and hospital admissions respectively, but no reduction in total mortality or 
further cardiovascular events (Anderson et al., 2016). Despite BACPR recommending reducing 
sedentary behaviour following a cardiac event, there is scarce evidence regarding the association of 
sedentary behaviour with cardiovascular risk or cardiac related outocmes in this population group 
(Freene et al., 2022). 
Sedentary behaviour is defined as a waking energy expenditure of £1.5 METs (metabolic task 
equivalent) while in a seated, reclined or lying posture (Tremblay et al., 2017).. Due to technological 
advancements and changes in social norms and workplace behaviours, many population grous engage 
in high amounts of sedentary behaviour. For instance, in 1377 older men in the UK, self-reported data 
showed an average of 317 minutes per day of TV viewing, reading, commuting and car use {Jefferis, 
2016 #265546}.  Further to this, accelerometer derived findings within this study reported an average of 
619 minutes per day of sedentary time in older men (Parsons et al., 2016). An international study of 
49,493 participants from 20 countries across the world reported a median of 300 minutes per day of 
sitting (Bauman et al., 2011). However, studies using self-report methods are limited as individuals 
typically underestimate their sitting time. This may underestimate the true magnitude of association 

Sedentary time and IHD 
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between sitting time and cardiovascular risk markers. A comparison study of a self-reported 
questionnaire (international physical activity questionnaire (IPAQ)) and an activPAL accelerometer upon 
sitting time confirms this, where the IPAQ was found to underestimate sitting time by 3.4 hours per 
day(Chastin et al., 2014). Hence, estimating sitting using device-based methods is important in 
contributing to knowledge regarding associations with health outcomes (Celis-Morales et al., 2012).  
Sedentary behaviour is associated with cardiovascular risk markers in the general population. Within 
the US National Health and Nutrition Examination Survey (NHANES) survey, a detrimental linear 
association was found between total time spent sedentary and waist circumference, high density 
lipoprotein cholesterol (HDL-C), triglycerides, insulin, insulin sensitivity and b cell function (Healy et al., 
2011). In addition, independent of total sitting time, a higher number of breaks in sitting per day was 
significantly beneficially associated with waist circumference, C-reactive protein and fasting plasma 
glucose (Healy et al., 2011). Therefore, both reducing total sedentary time and frequently breaking up 
prolonged periods of sedentary time are associated with improved cardiometabolic risk in the general 
population (Healy, et al., 2011). Further to this, a meta-analysis which reviewed the association between 
sedentary behaviour and blood pressure (BP) had somewhat varied findings (Lee & Wong, 2015). Of 
the 31 articles included, 18 articles found no association between sedentary behaviour and either 
systolic blood pressure (SBP) or diastolic blood pressure (DBP). Typically, those that did not find a 
significant association between SB and BP had a smaller sample size, and SB was objectively 
measured. Despite this, the subsequent meta-analysis (n=28) showed a significant association between 
SB and BP, of which every additional hour of SB per day was associated with an increase in 0.06 mmHg 
for SBP and 0.20 mmHg for DBP with an odds ratio of 1.02 (95% CI 1.00-1.03, p=0.02) for high blood 
pressure (both SBP and DBP). All studies adjusted for confounding variables, including age and sex, 
but some studies adjusted for more confounders than others (Lee & Wong, 2015). It is important to note 
that null findings were more prominent in studies that adjusted for moderate to vigorous physical activity, 
a historically known influence upon BP (Pescatello et al., 2004). However, these studies have typically 
been conducted in the general population, healthy individuals, or those who are overweight/ obese. 
There are currently limited studies that investigate the associations of sitting with cardiovascular risk 
factors in a population who have ischaemic heart disease. Furthermore, there appear to be no studies 
that have investigated the association of sitting time with cardiac function in this group, which is 
important to inform he potential important of targeting reductions in sedentary behaviour as part of 
cardiac rehabilitation. Therefore, the aim of this study is to determine the prevalence of device measured 
sitting and the association of sitting with cardiovascular risk factors and cardiac function in individuals 
who have ischaemic heart disease.  
 

Sedentary time and IHD 
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4 
RESEARCH QUESTION/AIM(S) 
1) How much time do individuals with ischaemic heart disease spend sitting per day? 
2) What is the association of daily sitting with cardiac function, structure and cardiovascular risk factors 
in ischaemic heart disease?  
 
4.1 
Objectives 
 
1) To identify daily sitting time in individuals with ischaemic heart disease in the first year of their 
cardiac recovery. 
2) To establish objective associations of sitting time with cardiac function, structure and 
cardiovascular risk factors, including anxiety and depression.  
 
 
5 
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
Study protocol  
An observational, cross-sectional study design will be used. Participants can have preliminary measures 
taken either during a visit to the Sport and Exercise Sciences Laboratories at the University of 
Bedfordshire or in their own home, depending on the participant’s preference. This consists of 
anthropometric measures (height, weight and waist circumference). Participants will then rest for 5 
minutes to achieve a steady state before baseline blood pressure is taken. Baseline cardiac function 
measures will be measured using an echocardiogram scan, as well as an electrocardiogram (ECG) to 
ensure there are no electrical contraindications to the heart (including new ST depression / elevation or 
any arrythmias) which would make the participant unsuitable to complete the study. Mood and wellbeing 
measures will then be assessed using questionnaires.  
Following this, participants will be asked to complete 7 full days of normal daily activity, whilst wearing 
an activPAL monitor on their thigh to record sitting, standing and stepping. The main data collection will 
take place at the participant’s home, workplace or leisure setting (i.e. under free-living conditions), with 
social distancing in place if required at the time of data collection.  Instructions will be given to help 
ensure that the 7-day monitoring period reflects their usual habits. The monitoring period will also be 
carefully decided, to ensure it does not conflict with any events that are out of the usual for the 
participant, such as holidays or work-based events, which would alter their usual sedentary patterns.  
Data collection 
Demographic data 

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Patient demographic data will include age, gender, diagnosis and intervention. This is routinely collected 
within Cardiac Rehabilitation as part of their usual standard of care.  
Height and weight 
Equipment to measure height, weight and waist circumference will include a stadiometer (Leicester 
Height Scale, Marsden HM-250P, Leicester, UK) to measure height in cm, a measurement tape for waist 
circumference and digital weighing scales (Tanita, BWB0800, Allied Weighing, UK) to measure weight 
in kg. 
 
Blood pressure and heart rate 
Blood pressure and heart rate will be measured in an upright, seated position using an automated device 
(Omron M5-1 automated oscillatory device, Omron Matsusaka Co. Ltd., Matsusaka, Japan). The left 
arm will be used to measure blood pressure unless there is preference for the right arm due to any 
potential previous medical conditions. Two measures will be taken, with 5 minutes apart.  
 
Cardiac function 
In a laboratory or in the participants home, the participant will be asked to undress from the waist up 
and lay on the medical couch in the left lateral decubitus position. Here, a scanning gel will be applied 
to the echocardiogram probe. This forms part of the echocardiogram system (Esoate, MyLab Omega, 
Italy). Parasternal and apical views will be acquired (Armstrong and Ryan., 2012). Once these images 
are collected and stored, the gel will be removed from the probe and chest. All images will be stored 
anonymously, where participants will be given a participant ID number. All image analysis will be 
completed using Echopac software (GE Healthcare, Version 113, GE healthcare, Chicago, Illinois, 
United States). Measures taken from the echocardiogram scan will be used to calculate left ventricular 
structure and function.  
 
Anxiety and Depression  
The Hospital Anxiety and Depression Scale {Zigmond, 1983 #285206} will be used to assess feelings 
of anxiety or depression.   
 
Measurement of sitting, standing and light physical activity 

Sedentary time and IHD 
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Following preliminary measures, sitting, standing and stepping will be monitored 24 h/day over seven 
full days using an activPAL activity monitor (PAL Technologies, Glasco, Scotland). This will measure 
changes in posture and level of activity by cadence. The activity monitor will be attached to the skin with 
a waterproof dressing on the anterior right thigh. standing. The Processing PAL application will be used 
to process the data collected from the activPAL device. It uses a vaildated algorithm to isolate waking 
and sleeping time and to generate the outcome data. Participants will also be given a 7 day activity diary 
to record waking times, and other relevant activities to cross-validate the Processing PAL measured 
sleep and wake times. 
 
Data analyses 
Statistical analyses will be conducted using SPSS Version 28 (IBM, Armonk, NY, USA). Descpritive 
statistics will be reported as mean and standard deviation (SD). Data will be checked for normality 
across each category using quantile-quantile plots.  Total sitting time, breaks in sitting, standing and 
light, moderate and vigorous intensity physical activity, and  total number of sit to stand transitions 
(frequency of breaks) data will be presented as mean and SD and also expressed as a percentage of 
daily waking time.  
Correlation coefficients will be used to explore relationships of sedentary time variables with cardiac and 
cardiovascular risk factors. Multiple regression analysis will be used to model each aforementioned 
independent variable separately with cardiovascular risk factors (blood pressure, BMI, waist 
circumference, anxiety and depression) and measures of cardiac function and structure. It will also be 
used to explore associations between sedentary time with cardiovascular risk factors and cardiac 
function and structure, adjusting for potential confounding variables, including type of condition, time 
since diagnosis of cardiac condition, age, gender, ethnicity, and socioeconomic status, and whether any 
measures are confounding variables to the association between sedentary time with cardiovascular risk 
factors and cardiac function and structure.   
 
 
7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
7.1.1 Inclusion criteria  
• 
Patients diagnosed with ischemic heart disease within the past 12 months (within 
National Audit of Cardiac Rehabilitation (NACR) outcome data). This includes post 
myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI), post coronary 
artery bypass graft, post percutaneous coronary intervention.  

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• 
Males and females 
• 
Aged 18 years or above. 
• 
Any ethnicity. 
7.1.2 Exclusion criteria  
• 
Under 18 years of age. 
• 
Unable to provide valid informed consent (lack of mental capacity). 
• 
Not had a cardiac event diagnosed within the past 12 months.  
• 
Unstable coronary disease. 
• 
Disease or conditions with a prognosis of less than 6 months to end of life (palliative 
care).  
 
7.2  
Sampling 
7.2.1  Size of sample 
An estimated sample size was calculated using G* Power (version 3.1.9.4). Based on previous data 
(Carson et al., 2014), it was estimated that 67 participants would be needed to detect a medium 
correlation coefficient (r) of 0.3 between sedentary time and cardiac outcomes with 80% power at an 
alpha level of 5%.  If drop out occurs, participants will be replaced to ensure minimum recruitment is 
met. This decision will be pragmatic in accordance with study timeline.  
 
 
7.2.2  Sampling technique 
Eligible patients will be approached during Phase 1 and 2 of Cardiac Rehabilitation or via advertisements 
(posters, social media posts, email). Convenience sampling will be used to ensure sufficient recruitment 
to the study. 
 
7.3 
 Recruitment 
7.3.1 Sample identification 
Participants will be identified by a member of the University research team who will regularly attend CR 
initial assessment telephone clinics. This member is also employed at Bedford Hospital as a Cardiac 
Rehabilitation Exercise Specialist. They will have access to the clinic list and medical notes prior to the 
consultation, where they can be screened to check who may be eligible for the study. This is usual 
practice as part of the role of a Cardiac Rehabilitation Exercise Specialist. All members of the research 
team involved in recruitment will have an NIHR research passport and will have completed secondary 

Sedentary time and IHD 
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GCP (Cardiac Rehabilitation Exercise Specialist). Eligible patients will be approached by the Cardiac 
Rehabilitation Exercise Specialist to ask if they would be interested in volunteering to take part in the 
study via telephone.  
Participants will be approached after their initial CR appointment by a member of the research team to 
invite them to take part in the study via telephone. An introduction to the study will be given and the 
patient will be sent a participant information sheet (PIS) either via email or post. A consent to contact 
form will be completed that allows the research team to call the patient to discuss the study further and 
explore whether they are interested in participating. It is optional and refusal to do so does not in any 
way affect their usual standard of care. If they complete a consent to contact form, the patient will be 
given at least 24 hours to read the PIS and discuss with friends and family, to carefully consider their 
participation in the study.  
Participants will also be recruited using advertisements via recruitment posters, leaflets, emails, and 
social media.  
 
7.3.2 Consent 
Only patients with capacity to consent will be considered eligible for the study. If the patient would then 
like to participate in the study, an informed consent form will be given for them to complete and sign. 
Should a patient lose capacity during the follow up period, they will be withdrawn from the study. 
Identifiable data already collected with consent would be retained and potentially used in the study. No 
further data or samples would be collected or any other research procedures carried out. 
For an individual to have capacity to consent they will: understand the purpose and nature of the 
research; understand what the research involves, its benefits (or lack of benefits), risks and burdens; 
understand the alternatives to taking part; be able to retain the information long enough to make an 
effective decision; be able to make a free choice; be capable of making this particular decision at the 
time it needs to be made (though their capacity may fluctuate, and they may be capable of making some 
decisions but not others depending on their complexity). 
 
 
8 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
8.1 
Assessment and management of risk 
Disinfecting equipment 

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70% ethanol spray will be used to disinfect equipment and will be wiped before and after usage for each 
participant. Rigorous handwashing will be put in place using alcohol gel to avoid any picking any 
infections from surface or mouth.  
ActivPAL monitor wear 
There is a small risk that the medical grade dressing used to attach the activity monitor to the skin could 
cause irritation. If this occurs, the participant is encouraged to contact the research team immediately, 
where an alternative dressing will be provided along with regularly replacing the dressing and cleaning 
the area. If these methods do not resolve the issue then the participant would be withdrawn from the 
study.  
 
8.2  
 Research Ethics Committee (REC) and other Regulatory review & reports 
Before the start of the study, a favourable opinion will be sought from the NHS REC. 
• 
Substantial amendments that require review by NHS REC will not be implemented until that 
review is in place and other mechanisms are in place to implement at site.   
• 
All correspondence with the REC will be retained. 
• 
It is the Chief Investigator’s responsibility to produce the annual reports as required. The Chief 
Investigator will notify the REC of the end of the study. 
• 
An annual progress report (APR) will be submitted to the REC within 30 days of the anniversary 
date on which the favourable opinion was given, and annually until the study is declared ended. 
• 
If the study is ended prematurely, the Chief Investigator will notify the REC, including the reasons 
for the premature termination. 
• 
Within one year after the end of the study, the Chief Investigator will submit a final report with 
the results, including any publications/abstracts, to the REC. 
 
Regulatory Review & Compliance  
Before patients are enrolled into the study, the Chief Investigator will ensure that appropriate approvals 
from participating organisations are in place. Specific arrangements on how to gain approval from 
participating organisations are in place and comply with the relevant guidance. For any amendment to 
the study, the Chief Investigator, in agreement with the sponsor will submit information to the appropriate 
body in order for them to issue approval for the amendment. The Chief Investigator or designee will 
work with sites (R&D departments at NHS sites as well as the study delivery team) so they can put the 

Sedentary time and IHD 
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necessary arrangements in place to implement the amendment to confirm their support for the study as 
amended. 
Amendments  
If the sponsor wishes to make a substantial amendment to the REC application or the supporting 
documents, the sponsor will submit a valid notice of amendment to the REC for consideration. The REC 
will provide a response regarding the amendment within 35 days of receipt of the notice. It is the sponsor’s 
responsibility to decide whether an amendment is substantial or non-substantial for the purposes of 
submission to the REC. 
Amendments will also to be notified to the national coordinating function of the UK country where the lead 
NHS R&D office is based and communicated to the participating organisations (R&D office and local 
research team) departments of participating sites to assess whether the amendment affects the NHS 
permission for that site.  
In all instances the protocol will describe: 
• 
The process for making amendments.  
• 
Who will be responsible for the decision to amend the protocol and for deciding whether an 
amendment is substantial or non-substantial? 
• 
How substantive changes will be communicated to relevant stakeholders (e.g., REC, R&D, 
regulatory agencies). 
• 
How the amendment history will be tracked to identify the most recent protocol version. 
 
8.3  
Peer review 
As this study forms part of a PhD project, it has been reviewed by four academic supervisors.  
 
8.4  
Patient & Public Involvement 
Cardiac Rehabilitation Team at Bedford Hospital 
Regular meetings will be held between the Bedford Hospital Cardiac Rehabilitation team and the study 
investigators to discuss how to conduct the study in terms of participant recruitment, data collection and 
dissemination.  
 
8.5 
Protocol compliance  
Accidental protocol deviations can happen at any time. If they are to occur, they must be adequately 
documented and reported to the Chief Investigator and Sponsor immediately.  

Sedentary time and IHD 
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Deviations from the protocol which are found to frequently recur are not acceptable, will require 
immediate action and could potentially be classified as a serious breach. Here, they will also be reported 
to the NHS REC.  
 
8.6 
Data protection and patient confidentiality  
All investigators and study site staff will comply with the requirements of the Data Protection Act 2018 
with regards to the collection, storage, processing and disclosure of personal information and will uphold 
the Act’s core principles, to ensure that patient confidentiality is maintained at all times.  
Personal information on source documentation will be filed in a locked cabinet, with only the core 
research members allowed access. Upon registration to the study, participants will be given a unique 
participant ID number, which will henceforth be used in all data collection within the study. This will be 
determined using a number system (Move-01, etc.). A confidential log will be kept by the research team 
to identify participants with their anonymous ID numbers, which will be encrypted on a secure computer. 
All other electronic documentation will also be encrypted. Only direct members of the research team will 
have access to the data, and will be listed on the study’s delegation log.  Where data is transmitted to 
sponsors, if necessary, it will only be identifiable by its participant ID number, thus not becoming patient 
identifiable at any time.  
Upon completion of the study, data will be stored for a minimum of 5 years. The data custodian for the 
Project is Dr Joanna Richards, Senior Lecturer for Clinical Physiology.  
 
8.7 
Indemnity 
The University of Bedfordshire holds insurance and will provide indemnity to cover relative liabilities 
associated to this research project. Please see the University of Bedfordshire 'Certificate of Employers 
Liability Insurance' and 'Professional Indemnity Certificate', which includes insurance cover for research. 
 
8.8 
Access to the final study dataset 
All members of the research team will have access to the final study dataset. Following publication of 
the study, access may be available for secondary analysis of the anonymized dataset on reasonable 
request to the Chief Investigator, which would not be patient identifiable. All patient documentation will 
reflect the future use of these data in research if necessary.  
 

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9 
DISSEMINIATION POLICY 
9.1  
Dissemination policy 
All data arising from the study will be property of the University of Bedfordshire. On completion of the 
study, the data will be analysed and a final study report prepared. The full study report will be accessible 
by all, as it will be made publically available. The chief investigator will have the right to publish the final 
report. Participants will be notified of the outcome of this study by receiving a summary of its findings. 
Overall, a manuscript will be written for submission to a peer reviewed journal.  
 
9.2  
Authorship eligibility guidelines and any intended use of professional writers 
Authorship will be based on the following 4 criteria, in accordance with the ICMJE: 
• 
Substantial contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work; AND 
• 
Drafting the work or revising it critically for important intellectual content; AND 
• 
Final approval of the version to be published; AND 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
 
10 
REFERENCES 
Bauman, A., Ainsworth, B. E., Sallis, J. F., Hagströmer, M., Craig, C. L., Bull, F. C., . . . Sjöström, M. 
(2011). The descriptive epidemiology of sitting: a 20-country comparison using the 
International Physical Activity Questionnaire (IPAQ). American Journal of Preventive Medicine, 
41(2), 228-235.  
Carson, V., Wong, S. L., Winkler, E., Healy, G. N., Colley, R. C., & Tremblay, M. S. (2014). Patterns of 
sedentary time and cardiometabolic risk among Canadian adults. Preventive Medicine, 65, 23-
27. doi:https://doi.org/10.1016/j.ypmed.2014.04.005 
Celis-Morales, C. A., Perez-Bravo, F., Ibañez, L., Salas, C., Bailey, M. E., & Gill, J. M. (2012). 
Objective vs. self-reported physical activity and sedentary time: effects of measurement 
method on relationships with risk biomarkers. PLoS One, 7(5), e36345. 
doi:10.1371/journal.pone.0036345 
Chastin, S., Culhane, B., & Dall, P. (2014). Comparison of self-reported measure of sitting time (IPAQ) 
with objective measurement (activPAL). Physiological measurement, 35(11), 2319.  
Freene, N., McManus, M., Mair, T., Tan, R., & Davey, R. (2022). Association of device-measured 
physical activity and sedentary behaviour with cardiovascular risk factors, health-related 
quality-of-life and exercise capacity over 12-months in cardiac rehabilitation attendees with 
coronary heart disease. BMC Sports Science, Medicine and Rehabilitation, 14(1), 1-11.  
Healy, G. N., Matthews, C. E., Dunstan, D. W., Winkler, E. A., & Owen, N. (2011). Sedentary time and 
cardio-metabolic biomarkers in US adults: NHANES 2003–06. European Heart Journal, 32(5), 
590-597.  
Lee, P. H., & Wong, F. K. Y. (2015). The Association Between Time Spent in Sedentary Behaviors 
and Blood Pressure: A Systematic Review and Meta-Analysis. Sports Medicine, 45(6), 867-
880. doi:10.1007/s40279-015-0322-y 

Sedentary time and IHD 
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Parsons, T. J., Sartini, C., Ellins, E. A., Halcox, J. P., Smith, K. E., Ash, S., . . . Jefferis, B. J. (2016). 
Objectively measured physical activity and sedentary behaviour and ankle brachial index: 
Cross-sectional and longitudinal associations in older men. Atherosclerosis, 247, 28-34. 
doi:10.1016/j.atherosclerosis.2016.01.038 
Pescatello, L. S., Franklin, B. A., Fagard, R., Farquhar, W. B., Kelley, G. A., & Ray, C. A. (2004). 
Exercise and hypertension. Medicine & Science in Sports & Exercise, 36(3), 533-553.