Back to resultsAssessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.
Primary Purpose
Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Combined - PAD and CAD
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring exercise rehabilitation, supervised exercise programmes
Eligibility Criteria
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).
Sites / Locations
- Salford Royal NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control - PAD
Combined - PAD and CAD
Arm Description
This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE.
This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Free-living physical activity levels
Accelerometer data recording activity levels outside of rehabilitation programme
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.
Full Information
NCT ID
NCT03564080
First Posted
February 5, 2018
Last Updated
February 20, 2023
Sponsor
University of Salford
Collaborators
Northern Care Alliance NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03564080
Brief Title
Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
September 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford
Collaborators
Northern Care Alliance NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication, Coronary Artery Disease
Keywords
exercise rehabilitation, supervised exercise programmes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomised control trial assessing feasibilty of new treatment method - combined supervised exercise programme
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - PAD
Arm Type
No Intervention
Arm Description
This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE.
Arm Title
Combined - PAD and CAD
Arm Type
Experimental
Arm Description
This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation).
Intervention Type
Other
Intervention Name(s)
Combined - PAD and CAD
Intervention Description
12-week supervised exercise programme in a hospital setting
Primary Outcome Measure Information:
Title
Walking distance
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Walking Impairment Questionnaire
Description
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.
Time Frame
12 weeks
Title
King's College Vascular Quality of Life Questionnaire (VascQual)
Description
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.
Time Frame
12 weeks
Title
Free-living physical activity levels
Description
Accelerometer data recording activity levels outside of rehabilitation programme
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.
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