Clinical trial NCT03506607: Hypoxic Exercise in Lower Extremity Artery Disease
Official title: Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: exercise
cardiovascular
normobaric hypoxia
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this randomized controlled trial is to:

Phase I: To explore, in a first pilot phase, the adequate combination of hypoxia severity and exercise intensity in patients with symptomatic lower extremity artery disease (LEAD). Acute walking performances and physiological responses (vascular and muscular) to a normobaric hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).

Detailed description: The results of this first phase will then be used to determine the optimal hypoxic level for the exercise training program which will be assessed during the Phase II.

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

Primary outcomes:
measure: Walking performance
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Pain free walking time
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Muscle oxygenation during exercise
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Pulse wave velocity
timeFrame: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Flow-mediated dilation
timeFrame: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Pulse oxygen saturation
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Secondary outcomes:
measure: Ankle-brachial index
timeFrame: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Toe-brachial index
timeFrame: Before and after each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Rate of perceived exertion
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
measure: Leg pain
timeFrame: After each 6 min treadmill test performed under hypoxic condition (1500 and 2500 m) and under normoxic condition (i.e., average of 3 weeks; one condition per week)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: Division of angiology, Lausanne University Hospital
name: Lucia Mazzolai, Prof
role: PRINCIPAL_INVESTIGATOR
References: