Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06132516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-30
Brief Title:
Effects of HIIT on HRV in Sub-acute Post-stroke Patients
Sponsor:
Hôpital Léon Bérard
Organization:
Hôpital Léon Bérard
Study Overview
Official Title:
Effect of a High-intensity Interval-training on Heart Rate Variability Prognostic Parameters in Early Post-stroke Patients A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAVC
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 study with blinded assessment of the main criteria
Population NIHSS20 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 31 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
Design A randomized controlled study with blinded assessment of the main criteria
Population NIHSS20 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 31 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
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 are screened for eligibility
Inclusion criteria
first-ever hemispheric stroke with consistent clinical and neuroimaging signs
3 month
NIHSS 20 in acute care
age18
Non-inclusion criteria
complicated diabetes mellitus with objective neuropathy andor autonomic dysfunction
other concomitant cardiac or pulmonary diseases possibly affecting HRV recordings ie acute myocardial infarction 6 month myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy class 3 and 4 heart failure arrhythmias including chronic atrial fibrillation conduction abnormalities
beta-blockers with no alternative options
severe cognitive impairment inconsistent with free informed and written consent or questionnaire filling
Patients will benefit beforehand from a symptom-limited Graded Exercise Test GXT with ECG monitoring and using a semi recumbent cycle ergometer Ergoline Optibike MED600 mainly to exclude a CV risk and to accurately assess their exercise capacities for better individualized programs Peak oxygen uptake Peak Power Peak Heart Rate Respiratory Exchange Ratio VO2peak Power peak HRpeak RER respectively will be measured Ventilatory Threshold 1 VT1 will be estimated and oxygen uptake power and heart rate at VT1 will be recorded VO2vt1 Pvt1 HRvt1
The global rehabilitation program will consist daily in a mean of 3 sessions 2 to 4 five days a week physiotherapy with among others Strengthening-Stretching activity occupational therapy cognitive therapy orthophonist or neuro-psychologist and either aerobic training HIIT or non-aerobic training Control Group-CG by Low Intensity Group Training-LIGT
HIIT and LIGT training volume and duration will be the same 16 sessions 6 weeks
The intervention-group HIIT Group will realize a 6-weeks Aerobic Training as follows
Among the FITT principle
Frequency 3 times a week
Intensity long-HIIT 4 to 5 four-minutes intervals at Pvt1 interspersed with two- minutes interval at 50 Pvt14-5 x 42Pvt1 50Psv1
short-HIIT 8 to 10 forty-five seconds intervals at Pmax interspersed with forty-five seconds intervals rest 8-10x4545Pmax Rest
Time 12 to 30 per session 8 short-sessions of 12 to 15 8 long-sessions of 24 to 30
Type cycling on a semirecumbent ergometer
In the CG group HIIT will be replaced by LIGT sessions as follows
Among the FITT principle
Frequency 3 times a week
Intensity Low HR controlled by HR monitoring 60 HRpeak or 30HRR
Time 12 to 30 per session 8 short-sessions of 12 to 15 8 long-sessions of 24 to 30
Type Static and Segmental strengthening and stretching mainly
Novelty
1 To use a new and strong risk marker of stroke relapse and post-stroke complications mortality morbidity and poor functional outcomes which is improved by physical activity to strengthen the use of Aerobic Training AT in secondary prevention
2 To allow generalization of conclusions
by studying AT with a shorter intervention-design limiting competition with neuro-rehabilitation fatigue time spent and via a simple intervention-device semi recumbent ergometer
Indeed most of non-ambulatory participants 82 in RCTs benefited from AT through assistive walking devices using Weight Bearing Support Treadmill which are difficult to set up accessibility personnel and equipment costs
by studying AT effects in a more disabled population and at an early stage Indeed in Randomized Controlled Studies having assessed AT in chronic 6months post-stroke patients NIHSS 542 was most often chosen for inclusion criterion with a median NIHSS around 3 at study start
Post-acute stroke patients hospitalized in rehabilitation stroke-units within secondary care hospitals are screened for eligibility
Inclusion criteria
first-ever hemispheric stroke with consistent clinical and neuroimaging signs
3 month
NIHSS 20 in acute care
age18
Non-inclusion criteria
complicated diabetes mellitus with objective neuropathy andor autonomic dysfunction
other concomitant cardiac or pulmonary diseases possibly affecting HRV recordings ie acute myocardial infarction 6 month myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy class 3 and 4 heart failure arrhythmias including chronic atrial fibrillation conduction abnormalities
beta-blockers with no alternative options
severe cognitive impairment inconsistent with free informed and written consent or questionnaire filling
Patients will benefit beforehand from a symptom-limited Graded Exercise Test GXT with ECG monitoring and using a semi recumbent cycle ergometer Ergoline Optibike MED600 mainly to exclude a CV risk and to accurately assess their exercise capacities for better individualized programs Peak oxygen uptake Peak Power Peak Heart Rate Respiratory Exchange Ratio VO2peak Power peak HRpeak RER respectively will be measured Ventilatory Threshold 1 VT1 will be estimated and oxygen uptake power and heart rate at VT1 will be recorded VO2vt1 Pvt1 HRvt1
The global rehabilitation program will consist daily in a mean of 3 sessions 2 to 4 five days a week physiotherapy with among others Strengthening-Stretching activity occupational therapy cognitive therapy orthophonist or neuro-psychologist and either aerobic training HIIT or non-aerobic training Control Group-CG by Low Intensity Group Training-LIGT
HIIT and LIGT training volume and duration will be the same 16 sessions 6 weeks
The intervention-group HIIT Group will realize a 6-weeks Aerobic Training as follows
Among the FITT principle
Frequency 3 times a week
Intensity long-HIIT 4 to 5 four-minutes intervals at Pvt1 interspersed with two- minutes interval at 50 Pvt14-5 x 42Pvt1 50Psv1
short-HIIT 8 to 10 forty-five seconds intervals at Pmax interspersed with forty-five seconds intervals rest 8-10x4545Pmax Rest
Time 12 to 30 per session 8 short-sessions of 12 to 15 8 long-sessions of 24 to 30
Type cycling on a semirecumbent ergometer
In the CG group HIIT will be replaced by LIGT sessions as follows
Among the FITT principle
Frequency 3 times a week
Intensity Low HR controlled by HR monitoring 60 HRpeak or 30HRR
Time 12 to 30 per session 8 short-sessions of 12 to 15 8 long-sessions of 24 to 30
Type Static and Segmental strengthening and stretching mainly
Novelty
1 To use a new and strong risk marker of stroke relapse and post-stroke complications mortality morbidity and poor functional outcomes which is improved by physical activity to strengthen the use of Aerobic Training AT in secondary prevention
2 To allow generalization of conclusions
by studying AT with a shorter intervention-design limiting competition with neuro-rehabilitation fatigue time spent and via a simple intervention-device semi recumbent ergometer
Indeed most of non-ambulatory participants 82 in RCTs benefited from AT through assistive walking devices using Weight Bearing Support Treadmill which are difficult to set up accessibility personnel and equipment costs
by studying AT effects in a more disabled population and at an early stage Indeed in Randomized Controlled Studies having assessed AT in chronic 6months post-stroke patients NIHSS 542 was most often chosen for inclusion criterion with a median NIHSS around 3 at study start
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None