Peripheral Arterial DiseasesCLASHNCT02041169
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia
A study testing Subsequent walking performance in people with Peripheral Arterial Diseases and Intermittent Claudication, run by Rennes University Hospital at 1 site in France.
Trial summary
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Diseases, Intermittent Claudication
- What is being tested?
- Subsequent walking performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Sep 2018
- 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
- Age ≥ 18 years old
- Insured under the French social security system (according to French law)
- Presence of lower-extremity peripheral artery disease, defined by:
- A resting ankle-brachial index (ABI) ≤ 0.90
- OR if resting ABI > 0.90 and < 1.00, a decrease in recovery ankle systolic pressure or in recovery ABI from treadmill exercise higher than 30% or 20%, respectively (AHA recommendations).
- OR if resting ABI > 1.40, a toe pressure index ≤ 0.70
Show all 20Show fewer
- Maximal walking distance on treadmill (3.2 km/h, 10% grade) < 500m (a)
- Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b)
- As assessed during the medical appointment.
- According to our inclusion criteria, patients' leg symptoms that fell within the following leg symptom categories could be included in the study:
- Intermittent claudication. Patients that experience exertional calf pain that does not begin at rest and that forces them to stop walking and that relieves or lessens within 10 minutes of rest; ii) Atypical exertional leg pain/stop. This category can encompass diverse situations of exertional leg symptoms. In the present study, patients in this category were included if they experience exertional pain that does not begin at rest and that forces them to stop walking, but that do not involve only the calf(s) but also thigh(s) and/or buttock(s). Further, the exertional leg pain relieves or lessens within 10 minutes of rest; iii) Leg pain on exertion and rest. In this category, patients sometimes experience exertional leg pain at rest when they are standing still or sitting. On exertion, patients also experience a walking pain as described above. As reminded by Criqui et al., this category of patients with "pain at rest" should not be confused with patients that experience "rest pain", which usually refers to patients with such severe advanced PAD that ischemic pain is present even at rest. Patients with ischemic rest pain were not included in the study.
- Non-Inclusion criteria
- Exercise limitation due to symptoms not related to an arterial insufficiency in the lower limbs (e.g., dyspnea, angina pectoris)
- Contraindication for walking (Abdominal aortic aneurysm > 4 cm)
- Myocardial infarction and no stroke in the last 3 months
- Critical limb ischemia, amputation.
- Pregnant women
- Adult subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law).
- Patient living more than 50 km from the university hospital
- Patient unable to understand the instructions of the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.
In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.
Read more
This study is a prospective, cross-sectional study in exercise pathophysiology.
The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.
Secondary goals are :
- To determine the nature of the relationship between the recovery duration and subsequent walking performance.
- To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
- To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
- To study the influence of recovery duration on walking capacity from community-based measurement.
Read the detailed description
It is expected to determine for the first time an optimal recovery duration that would maximize the walking capacity of LEPAD patients.
In the medium term :
- To give indications to the LEPAD patients to manage their pain in the community without lower their physical activity.
- To limit the functional decline of LEPAD patients.
- To influence the quality of life and cardiovascular mortality. This would deserve furthers studies.
- Being tested
- Subsequent walking performance
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subsequent walking performanceOther
Subsequent walking performance
| Study group | Role | What they receive |
|---|---|---|
| Subsequent walking performance | Experimental | Subsequent walking performance Receives: Other: Subsequent walking performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
Measured: 32 days
Secondary outcomes (1)
Coefficient of determination determined from different curves fitting
Coefficient of determination determined from different curves fitting
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MAHE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041169
- Sponsor's protocol ID
- 35RC13-9907-CLASH
- Other IDs
- 2013-A01381-44, 13/34-914
- Acronym
- CLASH
- Status last verified
- May 2023
- First submitted
- 14 Jan 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
de Mullenheim PY, Chaudru S, Mahe G, Prioux J, Le Faucheur A. Clinical Interest of Ambulatory Assessment of Physical Activity and Walking Capacity in Peripheral Artery Disease. Scand J Med Sci Sports. 2016 Jul;26(7):716-30. doi: 10.1111/sms.12512. Epub 2015 Jul 15.
PubMed 26173488Chaudru S, Jehannin P, de Mullenheim PY, Klein H, Jaquinandi V, Mahe G, Le Faucheur A. Using wearable monitors to assess daily walking limitations induced by ischemic pain in peripheral artery disease. Scand J Med Sci Sports. 2019 Nov;29(11):1813-1826. doi: 10.1111/sms.13511. Epub 2019 Jul 31.
PubMed 31271680Donnou C, Chaudru S, Stivalet O, Paul E, Charasson M, Selli JM, Mauger C, Chapron A, Le Faucheur A, Jaquinandi V, Mahe G. How to become proficient in performance of the resting ankle-brachial index: Results of the first randomized controlled trial. Vasc Med. 2018 Apr;23(2):109-113. doi: 10.1177/1358863X17740993. Epub 2017 Nov 10.
PubMed 29125051de Mullenheim PY, Rouviere L, Emily M, Chaudru S, Kaladji A, Mahe G, Le Faucheur A. "Should I stay or should I go now?" Recovery time effect on walking capacity in symptomatic peripheral artery disease. J Appl Physiol (1985). 2021 Jul 1;131(1):207-219. doi: 10.1152/japplphysiol.00441.2020. Epub 2021 May 13.
PubMed 33982591
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
- ClinicalTrials.gov ID
- NCT02041169
- Acronym / sponsor ID
- CLASH / 35RC13-9907-CLASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.
In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.
This study is a prospective, cross-sectional study in exercise pathophysiology.
The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.
Secondary goals are :
- To determine the nature of the relationship between the recovery duration and subsequent walking performance.
- To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
- To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
- To study the influence of recovery duration on walking capacity from community-based measurement.
Detailed description
It is expected to determine for the first time an optimal recovery duration that would maximize the walking capacity of LEPAD patients.
In the medium term :
- To give indications to the LEPAD patients to manage their pain in the community without lower their physical activity.
- To limit the functional decline of LEPAD patients.
- To influence the quality of life and cardiovascular mortality. This would deserve furthers studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subsequent walking performance | Experimental | Other: Subsequent walking performanceSubsequent walking performance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years old
- Insured under the French social security system (according to French law)
- Presence of lower-extremity peripheral artery disease, defined by:
- Maximal walking distance on treadmill (3.2 km/h, 10% grade) < 500m (a)
- Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Subsequent walking performanceSubsequent walking performance | Other | Subsequent walking performance |
Primary outcome
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
Time frame: 32 days
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
1 secondary outcome
Coefficient of determination determined from different curves fitting
Time frame: 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 26173488de Mullenheim PY, Chaudru S, Mahe G, Prioux J, Le Faucheur A. Clinical Interest of Ambulatory Assessment of Physical Activity and Walking Capacity in Peripheral Artery Disease. Scand J Med Sci Sports. 2016 Jul;26(7):716-30. doi: 10.1111/sms.12512. Epub 2015 Jul 15.
- Results publication: PubMed 31271680Chaudru S, Jehannin P, de Mullenheim PY, Klein H, Jaquinandi V, Mahe G, Le Faucheur A. Using wearable monitors to assess daily walking limitations induced by ischemic pain in peripheral artery disease. Scand J Med Sci Sports. 2019 Nov;29(11):1813-1826. doi: 10.1111/sms.13511. Epub 2019 Jul 31.
- Results publication: PubMed 29125051Donnou C, Chaudru S, Stivalet O, Paul E, Charasson M, Selli JM, Mauger C, Chapron A, Le Faucheur A, Jaquinandi V, Mahe G. How to become proficient in performance of the resting ankle-brachial index: Results of the first randomized controlled trial. Vasc Med. 2018 Apr;23(2):109-113. doi: 10.1177/1358863X17740993. Epub 2017 Nov 10.
- Results publication: PubMed 33982591de Mullenheim PY, Rouviere L, Emily M, Chaudru S, Kaladji A, Mahe G, Le Faucheur A. "Should I stay or should I go now?" Recovery time effect on walking capacity in symptomatic peripheral artery disease. J Appl Physiol (1985). 2021 Jul 1;131(1):207-219. doi: 10.1152/japplphysiol.00441.2020. Epub 2021 May 13.
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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.
Guillaume MAHE, MD principal investigator
Rennes 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 Subsequent walking performance in people with Peripheral Arterial Diseases and Intermittent Claudication, run by Rennes University Hospital at 1 site in France.
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 20 inclusion and 0 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: finished, as of the sponsor's last update on 24 May 2023. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses. (time frame: 32 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041169, which also lists 4 linked publications.
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 May 2023.