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

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dc.contributor.authorMura, Mathilde
dc.contributor.authorRivoire, Emeraude
dc.contributor.authorDehina-Khenniche, Leila
dc.contributor.authorWeiss-Gayet, Michèle
dc.contributor.authorChazaud, Bénédicte
dc.contributor.authorFaes, Camille
dc.contributor.authorConnes, Philippe
dc.contributor.authorLong, Anne
dc.contributor.authorRytz, Chantal L.
dc.contributor.authorMury, Pauline
dc.contributor.authorDelrieu, Lidia
dc.contributor.authorGouraud, Etienne
dc.contributor.authorBordet, Marine
dc.contributor.authorSchiava, Nellie D.
dc.contributor.authorLermusiaux, Patrick
dc.contributor.authorArsicot, Matthieu
dc.contributor.authorMillon, Antoine
dc.contributor.authorPialoux, Vincent
dc.date.accessioned2022-02-20T01:03:30Z
dc.date.available2022-02-20T01:03:30Z
dc.date.issued2022-02-14
dc.date.updated2022-02-20T01:03:29Z
dc.description.abstractAbstract Background Carotid atherosclerotic plaques remain silent until their rupture, which may lead to detrimental ischemic events such as strokes. This is due, in part, to intraplaque hemorrhages (IPH) and the resulting inflammatory processes, which may promote carotid plaque vulnerability. Currently, the benefits of carotid endarterectomy remain unclear for asymptomatic patients. Interestingly, the completion of physical activity (PA) may have beneficial effects; however, the paucity of current data warrants robust longitudinal interventions. We therefore aim to study the effects of a 6-month longitudinal personalized home-based PA program on IPH, biological, and inflammatory markers in asymptomatic stroke patients. Methods Eighty patients (≥ 18 years old) will be recruited for the Physical Activity and Carotid Atherosclerotic Plaque Hemorrhage (PACAPh) clinical trial from the Hospices Civils de Lyon. Patients will be eligible if they present with carotid stenosis ≥ 50% and are asymptomatic from any ischemic events for at least 6 months. Recruited patients will be randomized into either a PA or a control group, and assessed at baseline and after 6 months. At both time points, all patients will be assessed using magnetic resonance imaging to assess IPH, blood sampling to measure inflammatory markers and monocytic phenotyping, PA and sedentary behavior questionnaires, 6-min walking test, and maximal isometric quadricep contraction test. The randomized PA intervention will consist of reaching a daily walking step goal individually tailored to each patient. Steps will be collected using a wirelessly connected wristband. The number of steps completed by individuals in the PA group will be re-evaluated bimonthly to encourage walking habits. Discussion The PACAPh study is the first of its kind representing a feasible, easily accessible therapeutic strategy for asymptomatic stroke patients. We hypothesize that the personalized home-based PA program will reduce IPH and modulate inflammatory and biological parameters in patients presenting with carotid plaques. If the results of the PACAPh study prove to be beneficial on such health parameters, the implementation of such kind of intervention in the daily treatment of these patients would be an advantageous and cost-effective practice to adopt globally. Trial registration This study has been approved by the National Ethics Committee (IDRCB:2019-A01543-54/SI:19.06.21.40640). ClinicalTrials.gov NCT04053166
dc.identifier.citationTrials. 2022 Feb 14;23(1):145
dc.identifier.doihttps://doi.org/10.1186/s13063-022-06061-x
dc.identifier.urihttp://hdl.handle.net/1880/114427
dc.language.rfc3066en
dc.rights.holderThe Author(s)
dc.titleEffectiveness 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
dc.typeJournal Article
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