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.|
|ClinicalTrials.gov Identifier: NCT03564080|
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
|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)|
|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.|
|Estimated Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
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
- 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.
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)||firstname.lastname@example.org|