Individualized Physical Activity and Carotid Plaque Instability
NCT ID: NCT04053166
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2019-12-03
2022-09-21
Brief Summary
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This study has been designed as a monocentric, longitudinal and interventional study. This study will involve one centre: Hopital Louis Pradel (HCL, Lyon). After inclusion tests, patients will be randomly included in the control group, or in the PA group. Patients of the PA group will have connected bracelets to measure daily count of steps. Twice a month, daily goals will be revaluated to increase or maintain the steps per day. The final goal is to reach 6 000 steps per day or increase by 30% the initial count of steps per day. Same tests will be done after 6 months of intervention for comparison.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Individualized home-based physical activity
The subjects of this arm will have a daily goal in number of steps based on the initial 2 first week evaluation of daily number of steps. They will wear connected wrists, and will be contacted twice a month by phone call by the adapted physical activity trainer to revaluate these goals.
individualized home-based physical activity
Subjects will have to reach a daily goal in number of steps, based on the initial evaluation, during 6 months . They will wear connected wrists, and will be contacted twice a month by phone call by an adapted physical activity to revaluate these goals.
MRI
An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
blood sampling
Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
Questionnaires
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
6-minute walk test
The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
Control group
The subjects of this arm will not have evaluation of daily steps and recommendations regarding physical activity and sedentary behaviour. They will be asked to live as usual.
MRI
An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
blood sampling
Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
Questionnaires
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
6-minute walk test
The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
Interventions
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individualized home-based physical activity
Subjects will have to reach a daily goal in number of steps, based on the initial evaluation, during 6 months . They will wear connected wrists, and will be contacted twice a month by phone call by an adapted physical activity to revaluate these goals.
MRI
An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
blood sampling
Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
Questionnaires
sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
6-minute walk test
The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
Eligibility Criteria
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Inclusion Criteria
* Patient from vascular surgery department of the Louis Pradel Hospital of the Hospices Civils de Lyon, but not operated
* Males and females aged over 18 years old
* No contra-indication to physical activity with index performance (PS) \< 2
* Available and voluntary to invest in the study throughout its duration (6 months)
* Able to understand, read and write French;
* a social security system or similar;
* Having dated and signed informed consent.
Exclusion Criteria
* History of ipsilateral carotid surgery or cervical irradiation;
* Cancer, heart failure, seropositivity;
* Coronary risk;
* Renal failure (Cockcroft clearance of creatinine \< 30 milliliter/minute (mL/min);
* Contraindication and precautions for use related to Prohance: hypersensitivity to the active substance or to any of the constituents of Prohance, renal insufficiency with clearance \<30 ml / min / 1.73 m², probability of convulsions during the higher examination in patients with epilepsy or brain injury, pregnancy, breastfeeding;
* Contraindication to MRI: ferromagnetic material (including pacemaker, implantable defibrillators, cardiac valve prostheses, cochlear implants, neurostimulators, implanted automated injection equipment, intraocular metallic foreign bodies, neurosurgical and vascular clips);
* Carotid occlusion;
* ipsilateral intracranial stenosis;
* Risk of pregnancy or proven pregnancy on interrogation data. Breastfeeding;
* Patient under guardianship, under curatorship or safeguard of justice;
* inability to express consent;
* uncontrolled cardiological or neurological diseases;
* Impossibility of being followed for medical, social, geographical or psychological reasons throughout the duration of the study.
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Louis Pradel
Bron, , France
Countries
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References
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Mura M, Rivoire E, Dehina-Khenniche L, Weiss-Gayet M, Chazaud B, Faes C, Connes P, Long A, Rytz CL, Mury P, Delrieu L, Gouraud E, Bordet M, Della Schiava N, Lermusiaux P, Arsicot M, Millon A, Pialoux V. Effectiveness of an individualized home-based physical activity program in surgery-free non-endarterectomized asymptomatic stroke patients: a study protocol for the PACAPh interventional randomized trial. Trials. 2022 Feb 14;23(1):145. doi: 10.1186/s13063-022-06061-x.
Mura M, Rivoire E, Dehina-Khenniche L, Jazzar G, Schlatter S, Della-Schiava N, Arsicot M, Fayad ZA, Lermusiaux P, Long A, Douek P, Chirico EN, Thomas A, Pialoux V, Millon A. Influence of a six-month home-based individualized physical activity intervention on carotid plaque instability measured by magnetic resonance imaging: a randomized controlled clinical trial. EClinicalMedicine. 2025 Apr 22;83:103158. doi: 10.1016/j.eclinm.2025.103158. eCollection 2025 May.
Other Identifiers
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2019-A01543-54
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL19_0345
Identifier Type: -
Identifier Source: org_study_id