Ireland
--:--IST
Active, not recruiting Not applicable

Effects of HIIT on HRV in Sub-acute Post-stroke Patients

NCT06132516 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital Léon Bérard
Phase
Not applicable
Started
2024-03-15
Last updated
2025-12-31

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

HIITLIGT

HIIT: High Intensity Interval Training On semi-recumbent ergocyclometer, after a symptom-limited graded exercise Test

LIGT: Low Intensity Group Training Group gymnastics, mainly with short static stretching/strengthening tasks.

Study 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 study with blinded assessment of the main criteria.

Population. NIHSS\<20 post-stroke patients, hospitalized in secondary care stroke-units within the first 3 months (sub-acute phase).

Selection. Eligibility test on a semi-recumbent cycloergometer Intervention. In addition to a standard neurorehabilitation program (3±1 sessions daily, including cognitive and occupational therapy, physiotherapy with strengthening-stretching exercises), the aerobic group will benefit from a HIIT procedure (HIIT group) with a semi-recumbent cycloergometer, for 6 weeks representing 16 sessions; while the non-aerobic group will undertake a "Low-Intensity Group-Gymnastic Training" (Control or LIGT Group) (=segmental strengthening-stretching and proprioceptive exercises mainly), with the same training volume and frequency for both groups.

Main outcome measure. Standard Deviation of Normal-to-Normal RR intervals (SDNN) from 24h Holter-ECG recordings at W4, W8 and M6.

Modifications in patients' medical management are expected, as generalization of AT in moderate to severe stroke patients at the sub-acute phase, with "Low volume HIIT" and simple devices.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * first-ever hemispheric stroke, with consistent clinical and neuroimaging signs * \<3 month * NIHSS \<20 in acute care Exclusion Criteria: * 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

Primary outcome measure(s)

  • SDNN — Week 1, Week 8, Month 6
    Standard Deviation of all Normal-to-Normal RR intervals, recorded with a 24h-Holter ECG.

Trial sites (1)

FacilityCityRegionStatus
Dr BARTHOLOMEI MN Hyères PACA
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06132516 on ClinicalTrials.gov ↗ ← All trials in France