Status:
ACTIVE_NOT_RECRUITING
Effects of HIIT on HRV in Sub-acute Post-stroke Patients
Lead Sponsor:
Hôpital Léon Bérard
Collaborating Sponsors:
Fondation de l'Avenir
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objective. To assess the effect of innovative "High-Intensity Interval Training" (HIIT) on Heart Rate Variability, a strong biomarker of positive outcome after stroke. Design. A randomized controlled...
Detailed Description
A randomized controlled 2-arms parallel study, comparing HRV in two groups of stroke patients. Post-acute stroke patients hospitalized in rehabilitation stroke¬-units, within secondary care hospitals...
Eligibility Criteria
Inclusion
- first-ever hemispheric stroke, with consistent clinical and neuroimaging signs
- \<3 month
- NIHSS \<20 in acute care
Exclusion
- age\<18 years-old
- diabetes mellitus complicated by neuropathy or autonomic dysfunction; or any other concomitant nervous system, cardiac or pulmonary disease possibly affecting the autonomic nervous system ie:
- myocardial infarction\< 6 months,
- myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy, class 3 and 4 heart failure,
- severe conduction abnormalities and arrhythmias, including chronic atrial fibrillation,
- mechanical ventilation,
- beta-blockers with no alternative options, pharmacological mandatory treatment possibly affecting the autonomic nervous system and HRV.
- severe cognitive impairment inconsistent with free, informed and written consent or questionnaire filling
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06132516
Start Date
March 15 2024
End Date
September 1 2027
Last Update
December 31 2025
Active Locations (1)
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1
Dr BARTHOLOMEI MN
Hyères, PACA, France, 83418