An Investigation Into the Feasibility of Incorporating an Exercise Rehabilitation Programme for People With Peripheral Artery Disease Into an Already Established Cardiac Rehabilitation Service.
Phase: NA
Conditions: Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication, Coronary Artery Disease
Sponsor: University of Salford

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Study Title: An investigation into the feasibility of incorporating an 
exercise rehabilitation programme for people with intermittent 
claudication into an already established Cardiac Rehabilitation 
service 
 
 
Protocol 
Overview 
This study will look at the feasibility of combining patients with peripheral artery disease 
(PAD) and coronary artery disease (CAD) into one supervised exercise programme (SEP). The 
study will assess the effects of the intervention quantitatively, and also investigate the patient 
experience qualitatively by applying a mixed methods design (figure 1).  The initial phase of 
the research will quantitatively analyse pre and post-intervention outcomes, followed by 
qualitative investigation into the thoughts and concerns about the intervention. The rationale 
for this mixed methods approach is that it provides strengths that offset the weaknesses of 
both qualitative and quantitative methods when used in isolation (Creswell & Plano Clarke, 
2007). Also in clinical settings such as in the NHS, exploring the views and experiences of the 
service users to gain greater understanding has been shown to improve service provision and 
subsequently patient uptake (Risom et al., 2013).  

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Figure 1: This diagram shows the mixed methods approach of the research study, with the qualitative 
element following on from the quantitative measurement of the intervention outcomes. The results of 
each arm will be merged to show the overall effectiveness of the intervention. 
 
 
 
 
 
Recruitment Strategy: 
Intervention group: 
Participants for the combined SEP will be recruited from a local NHS Vascular Service at 
Salford Royal NHS Foundation Trust (SRFT). They will be identified by the vascular specialist 
teams (surgeons, nurses and podiatrists) and asked if they wish to take part in the study. The 
participants will be asked during the face-to-face consultation with their specialist, or a 
telephone consultation. This will give participants 1-2 week period to consider enrolling in the 
research programme. Participation will be on a voluntary basis. Simultaneously, an age-
matched group of coronary artery disease (CAD) patients will be recruited to the combined 
programme to assess the impact of combined SEP on CAD patients. These participants will be 
identified by the Cardiac Rehabilitation Specialist Nurses at SRFT upon referral to the CR SEP 
and will have a similar 1-2 week period to decide about enrolling. 
 

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Control group or “standard care” group: 
A control group will also be recruited. This group will be made of PAD patients only and will 
take place at an established SEP at Central Manchester University Hospitals. The use of a SEP 
has been chosen as the control group or “standard care” group, even though most patients 
are unable to receive the standard care in the UK. Other research in this area has had an 
“exercise advice only” group as control (Cheetham et al., 2004) however, it has been 
established that SEPs are better than “exercise advice only” as a treatment option 
(Bendermacher, Willigendal, Teijink and Prins, 2009). Therefore it would be unethical for 
some participants to be missing out on the recommended SEP treatment.  
The CAD patient’s outcomes will be compared to the National Audit of Cardiac Rehabilitation 
(NACR) as it is outside of the scope of this investigation to have a CAD only control group. The 
NACR data is compiled annually and records all of the outcome measures that are included in 
this study. The recent year’s audit results will be used for comparison. 
Informed Consent 
In order to gain informed consent from prospective participants, the content and layout will 
verbally be given to prospective participants, along with an easy-to-read leaflet/letter with 
full description of the study (see Patient Information Sheet in supporting documents). To 
avoid any risk of coercion, it will be explicitly stated that they have the right to withdraw from 
the study at any point, and that no present or future treatment will be affected by enrolling 
or not enrolling on the study. All documents will be available in large print if required.  
 
Sample size:  
The sample size of this investigation has been guided by a study by Evans et al., (2010) which 
investigated the suitability of combining two different patient groups (heart failure and 
chronic obstructive pulmonary disorder) into one rehabilitation programme. The authors of 
this study established that 17 participants were required in each group to reach significance 
level.  
There will be 3 participant groups in this study: The stand-alone PAD group; the combined 
PAD group, and the combined CR group (see figure 2). In order to generate sufficient data 34 

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patients will be recruited to each group with an aim to achieve 17 completers from each 
group. This is due to an expectation of high dropout rate for both PAD and CAD programmes 
seen at a national level (NACR, 2016; Shalhoub et al., 2009). The total recruited will therefore 
be 102 subjects, to gain 51 completers totally (17 per group). 
 
Figure 2 - Flowchart of study. This shows the outline of the 12 week study with the 3 groups involved 
Inclusion and Exclusion Criteria 
General criteria 
As part of this study participants will be required to wear an accelerometer on the first week 
and last week of the 12 week study. The accelerometer will be kept in place by a medical 
dressing (e.g. Tegederm). People with an existing skin condition such as psoriasis or eczema 

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that would be affected by the application of a medical dressing will be excluded from the 
study. 
All participants must be able to start the incremental shuttle walk test (walking speed of 
1.8kph, 1.1 mph). If they are unable to walk at this pace they will be excluded from the study. 
All participants must be able to engage in the exercises prescribed in the programme (see 
Supervised Exercise Programme outline below). 
No participant will be excluded due to age or gender.   
Inclusion Criteria – PAD patients: 
All patients recruited will have had a recent diagnosis (0 – 12 months) of PAD made by either 
a vascular surgeon, vascular specialist nurse or specialist podiatrist.  
 
Exclusion criteria – PAD patients: 
Any patient who has had previous intervention for PAD e.g. balloon angioplasty, stent, bypass 
or medication, or who have previously completed an SEP will be excluded from the study. This 
is due to the possibility of previous interventions having an impact on patient perceptions.  
Participants who are on medication for PAD (e.g. naftidrofuryl oxalate) will also be excluded 
from the study as this can increase symptom management and improve functional capacity.   
Any PAD patient who also has a diagnosis of other cardiovascular conditions such as CAD or 
stroke, or chronic heart failure will be excluded from this study, as the investigation is looking 
at the specific improvements in PAD, not CAD gains.  
Inclusion Criteria – CAD patients: 
All patients recruited to the CR group will have had a recent diagnosis (0-12 months) of CAD 
(angina, myocardial infarction (MI), or coronary artery bypass graft (CABG) or valve surgery).  
 
Exclusion criteria – CAD patients: 

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Any patient who has had previous diagnosis of PAD will be excluded from the study, as this 
may mask any gains in improvement due to CAD-specific rehabilitation in the CAD group (Tam 
et al., 2016). 
Any participant who has unstable CAD (e.g. unstable angina) will be excluded from the study 
as this is a contraindication partaking in structured exercise programme (BACPR, 2012).  
Study Design  
Initial Assessment 
All participants will be fully assessed prior to starting their 12 week SEP. This assessment is a 
standard part of the SEP process where a range of standard clinical measures are recorded 
(e.g. resting BP, BMI, and waist circumference). This will be conducted by one of the 
rehabilitation team members. All outcome measures will be taken prior to the patients 
starting their SEP and repeated upon completion of the programme. A summary of all 
outcome measures is shown in table 1. Completion will be categorised as attending 8 or 
more of their 12 sessions. 
 

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Table 1 – This table provides a summary of quantitative outcome measures and the time-point at which they will be recorded 
 
 
 
Outcome measures: 
The following items are the outcome measures that will be recorded. The PAD-specific tests 
have been recommended by the TransAtlantic Inter-Society Consensus (TASC) Working 
Group for the Management of PAD (2007). The others are standard outcomes measures 
recommended by the British Association of Cardiovascular Prevention and Rehabilitation 
(BACPR).  
 Incremental shuttle walk test (ISWT): This will assess walking distance, peak walking speed 
and functional capacity. For PAD patients it will also establish the pain-free and maximal 
walking distances. The ISWT is a functional exercise test (FET) that is commonly used 
throughout exercise rehabilitation programmes and research (Zwierska et al., 2005; Evans 
et al., 2010; ACPICR, 2015)  
 Walking behaviour and physical activity will be recorded by an Activpal® accelerometer 
(as used in Clarke et al. 2012) to quantify free-living walking. It will be attached to the 
front of the thigh using a medical grade waterproof dressing. It weighs 15g so will not be 
a physical burden to the participants. It will remain in place on the leg for a seven-day 
period, prior to starting the SEP. This will show baseline activity, and during the last week 
prior to them completing their SEP.  
 Quality of Life Measures 
o  Hospital Anxiety and Depression Scale (HADS) questionnaire 
 This is a 14-item questionnaire with 7 questions measuring anxiety and 7 
questions measuring depression levels. This is a commonly used in clinical 
settings and is a standard questionnaire used in Cardiac Rehab 
departments (Coats et al, 1995; BACPR, 2012; ACPICR, 2015). It takes on 
average 5 minutes to complete this questionnaire. 

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o King’s College Vascular Quality of Life (Vascu-QoL) Questionnaire (PAD-specific) 
 This is a 25-item questionnaire with 5 domains looking at disease-specific 
quality of life that has been widely used in PAD research (Morgan et al. 
2001; Vries et al. 2005). Disease-specific quality of life measures are 
recommended by TASC (2007) in combination with generic questionnaires 
(such as HADs) as they are more sensitive to change in specific symptoms 
that are related to the condition. This questionnaire takes on average 10 
minutes to complete. 
 Walking Impairment Questionnaire (WIQ): This is a PAD disease-specific questionnaire 
assessing the perceived impact of claudication symptoms on the individual being 
measured. This is a commonly used questionnaire in PAD research since its development 
by Regesteiner et al. (1995), and is recommended by TASC (2007) to assess patient 
perceived symptoms. It takes on average 5 minutes to complete. 
 
Supervised Exercise Programme Outline: 
The Programme 
Patients from all groups will attend a 2 hour supervised exercise session once a week, for 
12-weeksEach session will start with a pre-screening interview to confirm suitability to 
exercise that day. The exercise will start with a 10-15 minute warm up, followed by a 20-25 
minute conditioning phase, and a 10 minute cool-down. Successful completion of the 
programme will be achieved when 8 or more sessions are attended. 
 
PAD specific exercise 
The conditioning phase for the IC patients will involve completion of a range of exercises 
designed to bring on claudication within 3-4 minutes. Participants are encouraged to exercise 
to near-maximal claudication pain, and then rest until the pain has subsided before starting 
the next exercise. This is accordance with the AACVPR (2013) and NICE (2012) 
recommendations and will ensure safe and effective exercise. Monitoring and guidance will 

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be given throughout the exercise session by the rehabilitation team. The exercises will 
include: 
 Treadmill walking 
 Heel raises 
 Trampette walking/jogging 
 Sit to stands 
 Corridor walking  
 
CAD specific exercise 
The conditioning phase for CAD patients will consist of a range of cardiovascular exercises 
designed to improve cardiovascular fitness. This will follow the standard cardiac rehabilitation 
programme guidelines set by the BACPR (2012) and Association of Chartered Physiotherapist 
working in Cardiac Rehabilitation (ACPICR) (2015). 
Physical Activity and exercise advice: 
As the programme of exercise is only once a week, the rehabilitation team will provide 
guidance and encouragement for patients to keep active outside of the sessions. Patients will 
be given pedometers to use and weekly activity goals will be set and reviewed each week by 
a member of the rehabilitation team to assess progression.  
Patient education:  
Following each exercise session all patients will be invited to attend education sessions. The 
sessions are based on the clinical guidance from NICE (2012) recommending patients are 
educated on the importance of lifestyle interventions including: 
• 
aggressive lipid modification and statin therapy 
• 
smoking cessation 
• 
diet, weight management and exercise 
• 
the prevention, diagnosis and management of diabetes 
• 
the prevention, diagnosis and management of high blood pressure 

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• 
antiplatelet therapy  
 
 
 
Qualitative post-intervention study 
 
Upon completion of the 12-week supervised exercise programme, participants will be 
invited to attend focus groups to explore their thoughts and concerns about the 
intervention (Figure 2). Themes will be constructed from the data to give insight into the 
experiences of the different participant groups.  As participation is important for 
rehabilitation departments, it is essential to include the participants' perspective in the 
evaluation of the treatment programme.  
 
 
Data Analysis: 
Quantitative data: 
The outcome data will be tested to see if it is normally distributed or not. SPSS software will 
then be used to assess for any statistically significant differences between the groups.  
Within groups and between group differences in exercise capacity will be analysed using a 
factorial ANOVA to compare the difference in the levels of improvement between groups. 
Wilcoxon tests will be used to analyse the questionnaire data.  
The CAD group will also be compared to the National Audit of Cardiac Rehabilitation (NACR) 
data to assess the impact on the CAD group performance against expected national levels.  
The effect sizes will be calculated using the Cohen’s d so that the results can be compared to 
other studies. 
Qualitative Data: 
The analysis will be influenced by Braun & Clarke’s (2006) six phases of thematic analysis as 
described in Table 2. 
Phase 
Description of the process 

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1. Familiarizing yourself with your 
data: 
Transcribing data (if necessary), reading and re-reading 
the data, noting down initial ideas. 
2. Generating initial codes: 
Coding interesting features of the data in a systematic 
fashion across the entire data set, collating data relevant 
to each code. 
3. Searching for themes: 
Collating codes into potential themes, gathering all data 
relevant to each potential theme. 
4. Reviewing themes: 
Checking if the themes work in relation to the coded 
extracts (Level 1) and the entire data set (Level 2), 
generating a thematic ‘map’ of the analysis. 
5. Defining and naming themes: 
 
Ongoing analysis to refine the specifics of each theme, and 
the overall story the analysis tells, generating clear 
definitions and names for each theme. 
6. Producing the report: 
The final opportunity for analysis. Selection of vivid, 
compelling extract examples, final analysis of selected 
extracts, relating back of the analysis to the research 
question and literature, producing a scholarly report of 
the analysis. 
Table 2 This table outlines the steps taken in the thematic analysis of the focus group data. Taken 
from: Braun & Clarke, (2006) Using thematic analysis in psychology. Qualitative Research in Psychology. 3: 
pp77-101 
The results of both the quantitative data analysis and the thematic analysis from the focus 
groups will then be used to draw conclusions about the effectiveness of the treatment 
options. 
 
 

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References: 
 
American Association of Cardiovascular and Pulmonary Rehabilitation (2013) Guidelines for Cardiac 
Rehabilitation and Secondary Prevention Programs (4th ed.). Human Kinetics Publishers 
 
Association of Chartered Physiotherapist in Cardiac Rehabilitation (2015) ACPICR Standards for 
Physical Activity and Exercise in the Cardiovascular Population. ACPICR. 
 
BACPR (2012) Standards and Core Components for Cardiovascular Disease Prevention and 
Rehabilitation (2nd ed.). Available at: 
http://www.bacpr.com/resources/46C_BACPR_Standards_and_Core_Components_2012.pdf 
 
Bendermacher, B., Willigendael, E., Teijink, J. and Prins, M. (2009) ‘Supervised exercise therapy 
versus non-supervised exercise therapy for intermittent claudication’. Cochrane Database of 
Systematic Reviews, (2). doi: 10.1002/14651858. 
 
Braun, V., and Clarke, V. (2006) Using thematic analysis in psychology. Qualitative Research in 
Psychology, 3: 77-101 doi: 10.1191/1478088706qp063oa 
 
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Cheetham, D. ., Burgess, L., Ellis, M., Williams, A., Greenhalgh, R. and Davies, A. (2004) ‘Does 
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questionnaires for the assessment of quality of life in patients with peripheral arterial disease. 
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Tam, MC., Longenecker, CT., Chow, C., Vest, MV., Sukeena, R., Mohan, SKM., Carman, T., Parikh, SA, 
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