Trials / Unknown
UnknownNCT03506607
Hypoxic Exercise in Lower Extremity Artery Disease
Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Vaudois · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2018-04-24
- Last updated
- 2020-11-24
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03506607. Inclusion in this directory is not an endorsement.