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Hypoxic Exercise in Lower Extremity Artery Disease

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ClinicalTrials.gov Identifier: NCT03506607
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Lucia Mazzolai, Centre Hospitalier Universitaire Vaudois

Study Description
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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).


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Exercise in hypoxia 1500m Other: Exercise in hypoxia 2500m Other: Exercise in normoxia Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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%.
 Other: 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.
Experimental: 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%.
 Other: 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.
Placebo Comparator: 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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Walking performance [ Time Frame: 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) ]
    Total walking distance (in meters) during the 6 min treadmill test

  2. Pain free walking time [ Time Frame: 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 during the 6 min treadmill test

  3. Muscle oxygenation during exercise [ Time Frame: 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 the 6 min treadmill test (assessed by near-infrared spectroscopy)

  4. Pulse wave velocity [ Time Frame: 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 wave velocity before and after the 6 min treadmill test

  5. Flow-mediated dilation [ Time Frame: 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 before and after the 6 min treadmill test

  6. Pulse oxygen saturation [ Time Frame: 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 during the 6 min treadmill test


Secondary Outcome Measures :
  1. Ankle-brachial index [ Time Frame: 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) ]
    Ankle-brachial index before and after the 6 min treadmill test

  2. Toe-brachial index [ Time Frame: 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 the 6 min treadmill test

  3. Rate of perceived exertion [ Time Frame: 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 (RPE) will be assessed using Borg's scale. RPE is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during 6 min treadmill test. Patients will classify their RPE between 6 (light) and 20 (maximal).

  4. Leg pain [ Time Frame: 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 during exercise will be measured with a 10-points (0: "no pain" and 10: "worst imaginable pain") visual analogic scale (VAS).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506607


Contacts
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Contact: Lucia Mazzolai, Prof +41 (0)79 556 56 61 lucia.mazzolai@chuv.ch

Locations
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Switzerland
CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Lucia Mazzolai, Prof    +41213144700    lucia.mazzolai@chuv.ch   
Contact: Stefano Lanzi, PhD    +41795564911    stefano.lanzi@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Lucia Mazzolai, Prof Division of angiology, Lausanne University Hospital
More Information
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Responsible Party: Lucia Mazzolai, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03506607    
Other Study ID Numbers: 2017_00397_Phase1
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucia Mazzolai, Centre Hospitalier Universitaire Vaudois:
exercise
cardiovascular
normobaric hypoxia
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases