Hypoxic Exercise in Lower Extremity Artery Disease

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    20
  • sponsor
    Centre Hospitalier Universitaire Vaudois
Updated on 27 January 2021

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).

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.

Details
Condition Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Circulation Disorders, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment Exercise in hypoxia 1500m, Exercise in hypoxia 2500m, Exercise in normoxia
Clinical Study IdentifierNCT03506607
SponsorCentre Hospitalier Universitaire Vaudois
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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