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

NCT06132516 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-31

No results posted yet for this 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.

Conditions

Interventions

OTHER

HIIT

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

OTHER

LIGT

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

Sponsors & Collaborators

  • Fondation de l'Avenir

    collaborator OTHER

  • Hôpital Léon Bérard

    lead OTHER

Principal Investigators

  • Olivier Gavarry · Toulon University, STAPS Faculty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06132516 on ClinicalTrials.gov