Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.
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ClinicalTrials.gov Identifier: NCT03564080 |
Recruitment Status :
Recruiting
First Posted : June 20, 2018
Last Update Posted : December 4, 2018
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Arterial Disease Cardiovascular Diseases Intermittent Claudication Coronary Artery Disease | Other: Combined - PAD and CAD | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 102 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Non-randomised control trial assessing feasibilty of new treatment method - combined supervised exercise programme |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Investigation Into the Feasibility of Incorporating an Exercise Rehabilitation Programme for People With Peripheral Artery Disease Into an Already Established Cardiac Rehabilitation Service. |
Actual Study Start Date : | July 18, 2018 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
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No Intervention: Control - PAD
This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE.
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Experimental: Combined - PAD and CAD
This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation).
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Other: Combined - PAD and CAD
12-week supervised exercise programme in a hospital setting |
- Walking distance [ Time Frame: 12 weeks ]Initial and maximal pain free walking distances are measured using a Incremental Shuttle Walk Test. The symptoms of claudication pain are identified using the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) 0-4 Claudication scale. 0 is no claudication; 1 is initial pain; 2 is moderate pain; 3 is severe; 4 is maximal pain.
- Walking Impairment Questionnaire [ Time Frame: 12 weeks ]Patient's perceived walking distance and speed related to their claudication pain. Participants rate the distance and speed they are able to walk at. The distances are separated in to the amounts of blocks they can walk (with and without impairment). They then rate the speed they can walk 100 yards. The lower the score the worse the perceived limitation of their claudication symptoms.
- King's College Vascular Quality of Life Questionnaire (VascQual) [ Time Frame: 12 weeks ]Disease-specific quality of life questionnaire. The questionnaire is 25-item questionnaire subdivided into five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items). The higher the score the lower the health-related quality of life.
- Free-living physical activity levels [ Time Frame: 12 weeks ]Accelerometer data recording activity levels outside of rehabilitation programme
- Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ]The is a generic quality of life questions that assesses levels of anxiety and depression. There are 14 questions questions in total, 7 questions on anxiety and 7 on depression. Each question has an answer rating from 0-3, with 0 being no evidence of anxiety/depression, and 3 being maximum score. The total score for anxiety and depression are added (but anxiety and depression scores are not combined) to see the total reading for anxiety and depression. If 11 or above is scored in either anxiety or depression, then referral to appropriate health care professional is discussed with participant.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion 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 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).
All participants must be able to engage in the exercises prescribed in the programme
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.
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:
- 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.
Exclusion criteria - CAD patients:
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564080
Contact: Edward J Caldow, BSc (Hons) | 00441612958118 | e.j.caldow@salford.ac.uk |
United Kingdom | |
Salford Royal NHS Foundation Trust | Recruiting |
Salford, Manchester, United Kingdom, M6 8HD | |
Contact: Edward Caldow, BSc (Hons) 01612958118 e.j.caldow@salford.ac.uk |
Documents provided by Edward Caldow, University of Salford:
Responsible Party: | Edward Caldow, Post Graduate Student, University of Salford |
ClinicalTrials.gov Identifier: | NCT03564080 History of Changes |
Other Study ID Numbers: |
HSR1617-184 |
First Posted: | June 20, 2018 Key Record Dates |
Last Update Posted: | December 4, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Edward Caldow, University of Salford:
exercise rehabilitation supervised exercise programmes |
Additional relevant MeSH terms:
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Peripheral Arterial Disease Peripheral Vascular Diseases Intermittent Claudication |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Atherosclerosis Signs and Symptoms |