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Hypoxic Exercise in Lower Extremity Artery Disease

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise in hypoxia 1500m
Exercise in hypoxia 2500m
Exercise in normoxia
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Arterial Disease focused on measuring exercise, cardiovascular, normobaric hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Exercise in hypoxia 1500m

Exercise in hypoxia 2500m

Exercise in normoxia

Arm Description

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%.

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%.

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.

Outcomes

Primary Outcome Measures

Walking performance
Total walking distance (in meters) during the 6 min treadmill test
Pain free walking time
Pain free walking time during the 6 min treadmill test
Muscle oxygenation during exercise
Muscle oxygenation during the 6 min treadmill test (assessed by near-infrared spectroscopy)
Pulse wave velocity
Pulse wave velocity before and after the 6 min treadmill test
Flow-mediated dilation
Flow-mediated dilation before and after the 6 min treadmill test
Pulse oxygen saturation
Pulse oxygen saturation during the 6 min treadmill test

Secondary Outcome Measures

Ankle-brachial index
Ankle-brachial index before and after the 6 min treadmill test
Toe-brachial index
Toe-brachial index before and after the 6 min treadmill test
Rate of perceived exertion
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).
Leg pain
Leg pain during exercise will be measured with a 10-points (0: "no pain" and 10: "worst imaginable pain") visual analogic scale (VAS).

Full Information

First Posted
March 28, 2018
Last Updated
November 23, 2020
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT03506607
Brief Title
Hypoxic Exercise in Lower Extremity Artery Disease
Official Title
Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
exercise, cardiovascular, normobaric hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise in hypoxia 1500m
Arm Type
Experimental
Arm Description
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%.
Arm Title
Exercise in hypoxia 2500m
Arm Type
Experimental
Arm Description
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%.
Arm Title
Exercise in normoxia
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise in hypoxia 1500m
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise in hypoxia 2500m
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise in normoxia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking performance
Description
Total walking distance (in meters) during the 6 min treadmill test
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)
Title
Pain free walking time
Description
Pain free walking time during the 6 min treadmill test
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)
Title
Muscle oxygenation during exercise
Description
Muscle oxygenation during the 6 min treadmill test (assessed by near-infrared spectroscopy)
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)
Title
Pulse wave velocity
Description
Pulse wave velocity before and after the 6 min treadmill test
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)
Title
Flow-mediated dilation
Description
Flow-mediated dilation before and after the 6 min treadmill test
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)
Title
Pulse oxygen saturation
Description
Pulse oxygen saturation during the 6 min treadmill test
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)
Secondary Outcome Measure Information:
Title
Ankle-brachial index
Description
Ankle-brachial index before and after the 6 min treadmill test
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)
Title
Toe-brachial index
Description
Toe-brachial index before and after the 6 min treadmill test
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)
Title
Rate of perceived exertion
Description
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).
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)
Title
Leg pain
Description
Leg pain during exercise will be measured with a 10-points (0: "no pain" and 10: "worst imaginable pain") visual analogic scale (VAS).
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Mazzolai, Prof
Phone
+41 (0)79 556 56 61
Email
lucia.mazzolai@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Mazzolai, Prof
Organizational Affiliation
Division of angiology, Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Mazzolai, Prof
Phone
+41213144700
Email
lucia.mazzolai@chuv.ch
First Name & Middle Initial & Last Name & Degree
Stefano Lanzi, PhD
Phone
+41795564911
Email
stefano.lanzi@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypoxic Exercise in Lower Extremity Artery Disease

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