Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-01-23
2022-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Exercise in hypoxia 1500m
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%.
Exercise in hypoxia 1500m
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%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
Exercise in hypoxia 2500m
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%.
Exercise in hypoxia 2500m
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%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
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). For the exercise performed in normoxia conditions, subjects will breathe room air.
Exercise in normoxia
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. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
Interventions
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Exercise in hypoxia 1500m
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%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
Exercise in hypoxia 2500m
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%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
Exercise in normoxia
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. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
Eligibility Criteria
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Inclusion Criteria
* ABI ≤ 0.9
* TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency)
* Signed written informed consent form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Lucia Mazzolai
Principal Investigator
Principal Investigators
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Lucia Mazzolai, Prof
Role: PRINCIPAL_INVESTIGATOR
Division of angiology, Lausanne University Hospital
Locations
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CHUV
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Lucia Mazzolai, Prof
Role: primary
Stefano Lanzi, PhD
Role: backup
Other Identifiers
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2017_00397_Phase1
Identifier Type: -
Identifier Source: org_study_id