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

An Investigation Into the Feasibility of Incorporating an Exercise Rehabilitation Programme for People With Peripheral Artery Disease Into an Already Established Cardiac Rehabilitation Service.

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Other: Combined - PAD and CAD

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
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Impairment Questionnaire	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.	12 weeks
King's College Vascular Quality of Life Questionnaire (VascQual)	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.	12 weeks
Free-living physical activity levels	Accelerometer data recording activity levels outside of rehabilitation programme	12 weeks
Hospital Anxiety and Depression Scale	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Salford
• Collaborators: Northern Care Alliance NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): September 11, 2022

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: exercise rehabilitation; supervised exercise programmes
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: HSR1617-184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No