Status:
COMPLETED
Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery. This presents a major physical challe...
Eligibility Criteria
Inclusion
- 18 years old or over
- Willing to participate and able to give written informed consent
- Clinical diagnosis of critical limb ischaemia or Fontaine Class III-IV or Rutherford Class 4-6
- Admitted to the vascular surgical ward for lower limb surgery
Exclusion
- Patients presenting who have diabetes are presenting with acute limb ischaemia with no history of PAD
- Cognitive Impairment as demonstrated by not being able to safely follow instructions.
- Unable to understand or read English
- Absolute contraindications to exercise including:-
- Acute MI
- Ongoing unstable angina
- Uncontrolled cardiac arrhythmia with hemodynamic compromise
- Active endocarditis
- Symptomatic severe aortic stenosis
- Decompensated heart failure
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- Acute myocarditis or pericarditis
- Acute aortic dissection
- Physical disability that precludes safe and adequate exercise as determined by the clinical team
- Contraindications to IMT including:-
- A history of spontaneous pneumothrorax (ie not due to traumatic injury)
- A pneumothorax due to traumatic injury that has not fully healed
- A burst eardrum that has not fully healed or any other condition of the eardrum
- Unstable asthma and abnormally low perception of dyspnoea
Key Trial Info
Start Date :
August 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04043078
Start Date
August 3 2019
End Date
July 31 2020
Last Update
August 31 2020
Active Locations (1)
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1
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ