Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 8:36 PM
Study NCT ID:
NCT02041169
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASH
Brief 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 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 :
1. To determine the nature of the relationship between the recovery duration and subsequent walking performance.
2. To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
3. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
4. To study the influence of recovery duration on walking capacity from community-based measurement.
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 :
1. To determine the nature of the relationship between the recovery duration and subsequent walking performance.
2. To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
3. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
4. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: