Peripheral Arterial DiseaseNCT03506607
Hypoxic Exercise in Lower Extremity Artery Disease
A study testing Exercise in hypoxia 1500m, Exercise in hypoxia 2500m and Exercise in normoxia in people with Peripheral Arterial Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Exercise in hypoxia 1500m, Exercise in hypoxia 2500m and Exercise in normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jan 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Prior leg/foot amputation
- Pregnant women
- Cardiac contraindication to exercise
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Lucia Mazzolai, Prof, +41213144700, lucia.mazzolai@chuv.ch
Stefano Lanzi, PhD, +41795564911, stefano.lanzi@chuv.ch
About this study
Official title: Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
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).
Read the 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
- Peripheral Arterial Disease
- Being tested
- Exercise in hypoxia 1500m, Exercise in hypoxia 2500m, Exercise in normoxia
- Keywords
- exercise, cardiovascular, normobaric hypoxia
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in hypoxia 1500mOther
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.
Exercise in hypoxia 2500mOther
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.
Exercise in normoxiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise in hypoxia 1500m | Experimental | 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%. Receives: Other: Exercise in hypoxia 1500m |
| Exercise in hypoxia 2500m | Experimental | 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%. Receives: Other: Exercise in hypoxia 2500m |
| Exercise in normoxia | Placebo comparator | 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. Receives: Other: Exercise in normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking performance
Total walking distance (in meters) during the 6 min treadmill test
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Ankle-brachial index before and after the 6 min treadmill test
Measured: 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
Toe-brachial index before and after the 6 min treadmill test
Measured: 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
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).
Measured: 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
Leg pain during exercise will be measured with a 10-points (0: "no pain" and 10: "worst imaginable pain") visual analogic scale (VAS).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start23 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Mazzolai, Centre Hospitalier Universitaire Vaudois
- Investigators
- Lucia Mazzolai, Prof, Principal investigator, Division of angiology, Lausanne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506607
- Sponsor's protocol ID
- 2017_00397_Phase1
- Other IDs
- 2017
- Status last verified
- Nov 2020
- First submitted
- 28 Mar 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Under Hypoxic Conditions in Lower Extremity Artery Disease
- ClinicalTrials.gov ID
- NCT03506607
- Acronym / sponsor ID
- 2017_00397_Phase1
- Conditions
- Peripheral Arterial Disease
- Keywords
- exercise, cardiovascular, normobaric hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise in hypoxia 1500m | Experimental | Other: Exercise in hypoxia 1500mDuring 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 | Experimental | Other: Exercise in hypoxia 2500mDuring 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 comparator | Other: Exercise in normoxiaDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise in hypoxia 1500mSubjects 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 1500m |
| Exercise in hypoxia 2500mSubjects 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 hypoxia 2500m |
| Exercise in normoxiaSubjects 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. | Other | Exercise in normoxia |
Primary outcome
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
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
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)
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
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
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Mazzolai, Prof principal investigator
Division of angiology, Lausanne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in hypoxia 1500m, Exercise in hypoxia 2500m and Exercise in normoxia in people with Peripheral Arterial Disease, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia Mazzolai, Prof (+41 (0)79 556 56 61, lucia.mazzolai@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.