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

NCT03564080 | Completed

• 1 other identifier: HSR1617-184
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases; Intermittent Claudication; Coronary Artery Disease

Keywords

exercise rehabilitation; supervised exercise programmes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Walking Impairment Questionnaire

  12 weeks

• King's College Vascular Quality of Life Questionnaire (VascQual)

  12 weeks

• Free-living physical activity levels

  12 weeks

• Hospital Anxiety and Depression Scale

  12 weeks

Study Arms (2)

Control - PAD

NO INTERVENTION

This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE.

Combined - PAD and CAD

EXPERIMENTAL

This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation).

Other: Combined - PAD and CAD

Interventions

Combined - PAD and CAD OTHER

12-week supervised exercise programme in a hospital setting

Combined - PAD and CAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Salford: lead
• Northern Care Alliance NHS Foundation Trust: collaborator

Study Sites (1)

Salford Royal NHS Foundation Trust

Salford, Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases; Intermittent Claudication; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Student

Model Details: Non-randomised control trial assessing feasibilty of new treatment method - combined supervised exercise programme

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: June 20, 2018
• Study Start: July 18, 2018
• Primary Completion: October 28, 2019
• Study Completion: September 11, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)