Stroke Clinical Trial
— E(AVC)Official title:
Effect of a High-intensity Interval-training on "Heart Rate Variability" Prognostic Parameters in Early Post-stroke Patients: A Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hôpital Léon Bérard | Fondation de l'Avenir |
Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20. — View Citation
Colivicchi F, Bassi A, Santini M, Caltagirone C. Prognostic implications of right-sided insular damage, cardiac autonomic derangement, and arrhythmias after acute ischemic stroke. Stroke. 2005 Aug;36(8):1710-5. doi: 10.1161/01.STR.0000173400.19346.bd. Epub 2005 Jul 14. — View Citation
Fyfe-Johnson AL, Muller CJ, Alonso A, Folsom AR, Gottesman RF, Rosamond WD, Whitsel EA, Agarwal SK, MacLehose RF. Heart Rate Variability and Incident Stroke: The Atherosclerosis Risk in Communities Study. Stroke. 2016 Jun;47(6):1452-8. doi: 10.1161/STROKEAHA.116.012662. Epub 2016 May 5. — View Citation
Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available. — View Citation
Saunders DH, Sanderson M, Hayes S, Johnson L, Kramer S, Carter DD, Jarvis H, Brazzelli M, Mead GE. Physical fitness training for stroke patients. Cochrane Database Syst Rev. 2020 Mar 20;3(3):CD003316. doi: 10.1002/14651858.CD003316.pub7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SDNN | Standard Deviation of all Normal-to-Normal RR intervals, recorded with a 24h-Holter ECG. | Week 1, Week 8, Month 6 | |
Secondary | HRV | Others data from the Heart Rate Variability analysis | Week 1, Week 8, Month 6 | |
Secondary | Dose Ratio | Delivered/Planned ratio, as Internal Acceptability | Week 2 to Week 7 |
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