Hypoxic Exercise in Lower Extremity Artery Disease
Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedStudy Start
First participant enrolled
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 24, 2020
November 1, 2020
2.9 years
March 28, 2018
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Walking performance
Total walking distance (in meters) during the 6 min treadmill test
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)
Pain free walking time
Pain free walking time during the 6 min treadmill test
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)
Muscle oxygenation during exercise
Muscle oxygenation during the 6 min treadmill test (assessed by near-infrared spectroscopy)
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)
Pulse wave velocity
Pulse wave velocity before and after the 6 min treadmill test
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)
Flow-mediated dilation
Flow-mediated dilation before and after the 6 min treadmill test
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)
Pulse oxygen saturation
Pulse oxygen saturation during the 6 min treadmill test
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 (4)
Ankle-brachial index
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)
Toe-brachial index
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)
Rate of perceived exertion
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)
Leg pain
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)
Study Arms (3)
Exercise in hypoxia 1500m
EXPERIMENTALDuring 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 2500m
EXPERIMENTALDuring 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 normoxia
PLACEBO COMPARATORDuring 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.
Interventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucia Mazzolai, Prof
Division of angiology, Lausanne University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 28, 2018
First Posted
April 24, 2018
Study Start
January 23, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share