Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03564080
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : December 4, 2018
Salford Royal NHS Foundation Trust
Information provided by (Responsible Party):
Edward Caldow, University of Salford

Brief Summary:
This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Cardiovascular Diseases Intermittent Claudication Coronary Artery Disease Other: Combined - PAD and CAD Not Applicable

Detailed Description:
Peripheral artery disease (PAD) is a progressive disease that occurs as the result of atherosclerotic plaque formation in the major arteries of the leg (Mays, Casserly and Regesteiner, 2013). The main presenting symptom of PAD is intermittent claudication (IC) - exertional pain or discomfort in the calf, thigh or buttock that is relieved with rest. The presence of PAD is a very powerful marker of cardiovascular risk and preventable cardiovascular deaths. Following the initial diagnosis of PAD, for those patients without coronary artery disease the risk of systemic morbidity or mortality in the next 5 years is 50% (AACVPR, 2013). In 2012, the National Institute for Health and Care Excellence (NICE) issued guidelines stating that supervised exercise programmes (SEPs) should be offered as first-line treatment for people diagnosed PAD. However, there is a national shortage of dedicated SEPs for PAD patients that UK vascular specialists can refer patients to. There has been suggestion that an already established network of Cardiac Rehabilitation (CR) departments within the United Kingdom (UK) could cater for this group of patients, as they already have facilities and staff in place. To date, there has been no investigation into whether this would be successful. This research project would investigate if CR programmes could get the same outcomes for PAD patients as a stand-alone PAD rehabilitation programme. The study would investigate the possible positive and negative impact on both the PAD and CR patient groups in attending a combined rehabilitation programme of exercise and education. It will also look at the perceptions of the participants regarding the treatment programme itself.

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
No Intervention: Control - PAD
This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE.
Experimental: Combined - PAD and CAD
This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation).
Other: Combined - PAD and CAD
12-week supervised exercise programme in a hospital setting

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Free-living physical activity levels [ Time Frame: 12 weeks ]
    Accelerometer data recording activity levels outside of rehabilitation programme

  4. 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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03564080

Contact: Edward J Caldow, BSc (Hons) 00441612958118

United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Manchester, United Kingdom, M6 8HD
Contact: Edward Caldow, BSc (Hons)    01612958118   
Sponsors and Collaborators
University of Salford
Salford Royal NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Edward Caldow, University of Salford:
Study Protocol  [PDF] August 16, 2017
Statistical Analysis Plan  [PDF] August 16, 2017
Informed Consent Form  [PDF] June 11, 2018

Responsible Party: Edward Caldow, Post Graduate Student, University of Salford 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
Arterial Occlusive Diseases
Vascular Diseases
Signs and Symptoms