Status:
UNKNOWN
The RESPECT-PAD Trial
Lead Sponsor:
University of Manchester
Conditions:
Peripheral Arterial Disease
Cardiovascular Diseases
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
Peripheral arterial disease affects around 25% of the UK population aged over 55. Left untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly affects the lower li...
Eligibility Criteria
Inclusion
- Patients willing and able to undertake supervised or home-based exercise training aged between 40 and 85
- Positive Edinburgh questionnaire for intermittent claudication (APPENDIX H)
- Proven peripheral arterial disease on diagnostic imaging
- Ankle Brachial Pressure Index (ABPI) \<0.9
- Fontaine Classification (APPENDIX I) of PAD Stage II
- Conservative management plan agreed for by Consultant Vascular Surgeon.
Exclusion
- Critical limb ischaemia
- Asymptomatic peripheral arterial disease
- Ambulation limited by co-morbid condition other than claudication:
- Severe coronary artery disease, angina pectoris, chronic lung disease, neurological disorder, arthritis, amputation
- Contraindication to exercise training (AHA guidelines):71 acute MI (within 1 week), unstable angina, uncontrolled cardiac arrhythmias causing symptoms or haemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, acute pulmonary embolus, acute noncardiac disorder than may be aggravated by exercise such as infection, thyrotoxicosis, acute myocarditis, known physical disability that would preclude safe and adequate testing, known thrombosis of the lower limb, known left main stem coronary stenosis, moderate stenotic valvular heart disease, pulmonary hypertension, hypertrophic cardiomyopathy, atrio-ventricular block.
- Psychiatric disorder precluding them from consenting for research and/or exercise training
- Arterial reconstruction in the previous 12 months or planned within the next 6 months.
- Recent or upcoming major surgery (within 3 months)
- Unwilling or unable to attend/perform exercise training
- Non-atherosclerotic cause of PAD
- Other significant medical problems which impact on the patient's ability to complete a 12-week exercise programme, which could include:
- malignancy, chronic renal disease, chronic liver disease or anaemia, active substance abuse, dementia
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03298230
Start Date
November 1 2018
End Date
October 1 2019
Last Update
October 16 2018
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