Hypoxic Exercise in Lower Extremity Artery Disease
Peripheral Arterial Disease
About this trial
This is an interventional basic science trial for Peripheral Arterial Disease focused on measuring exercise, cardiovascular, normobaric hypoxia
Eligibility Criteria
Inclusion Criteria:
- Patients with symptomatic LEAD (Fontaine stage ≥ IIa)
- ABI ≤ 0.9
- TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency)
- Signed written informed consent form
Exclusion Criteria:
- Neurological and neuromuscular disorders which can limit balance and walking
- Any history of altitude-related sickness
- Any health risks (assessed during clinical history) linked to hypoxia exposure
- Acclimatization or exposure to hypoxia of more than 2000 m for more than 48 h during a period of 6 months before the study
- Medication required for the treatment of migraines, claustrophobia that may interfere with the interpretation of the results
- Obstructive sleep apnea (> 25 Apnea-Hypopnea Index)
- Prior leg/foot amputation
- Pregnant women
- Cardiac contraindication to exercise
Sites / Locations
- CHUVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Exercise in hypoxia 1500m
Exercise in hypoxia 2500m
Exercise in normoxia
During this visit, subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). The ambient air will be mixed with nitrogen and inspired oxygen fraction will be reduced to 16%.
During this visit, subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). The ambient air will be mixed with nitrogen and inspired oxygen fraction will be reduced to 14%.
During this visit, subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). For the exercise performed in normoxia conditions, subjects will breathe room air.