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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Toulouse | OTHER |
| Clinique Pasteur | OTHER |
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Purpose: Exaggerated sympathetic nervous system (SNS) activity associated with low heart rate variability (HRV) is considered as a trigger of cardiac arrhythmias and sudden death. Regular exercise training is efficient to improve autonomic balance. In 2013, the investigators published that a single session of an optimized short-high intensity interval exercise with passive recovery (HIIT) protocol was efficient in chronic heart failure (CHF) patients for enhancing vagal tone and to decrease arrhythmias in the 24-h post exercise period when compared to a single session of moderate intensity continuous exercise (MICT). Nevertheless the effects of HIIT training performed on several weeks have never yet been studied on the parameters described by Coumel's triangle (the arrhythmogenic substrate, the trigger factor as premature ventricular contraction and the modulation factors of which the most common is the autonomic nervous system). The aim of this study was to verify the superiority of HIIT to enhance parasympathetic activity, cardiorespiratory fitness and cardiac function when compared to MICT in a short and intense cardiac rehabilitation program.
Before and after the Rehabilitation Program (RP), all patients underwent a 24-hour ECG recording, an echocardiography, a cardiopulmonary exercise test.
The RP consisted of 2 types of exercise training according to the randomization:
The RP lasted 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high intensity interval training | Experimental | high intensity interval training: two sets of 8-min intervals at 100% of peak power output (PPO). Each interval set was composed of repeated bouts of 30 s at 100% of PPO interspersed by 30 s of passive recovery in the seated position. Four minutes of passive recovery were allowed between the two sets. |
|
| moderate intensity and continuous exercise | Active Comparator | moderate intensity and continuous exercise: 30 minutes at 60% of PPO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training in heart failure with HIIT | Behavioral | to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre. |
|
| Measure | Description | Time Frame |
|---|---|---|
| High Frequency power in normalized units (HFnu%) | based on Heart Rate Variability, the power spectral density of the HF (0.15-0.40 Hz, ms2.Hz-1) bands were calculated. | Change from baseline through study completion, an average of 4 weeks (measured during the night period for stationary signal) |
| Measure | Description | Time Frame |
|---|---|---|
| maximal oxygen consumption (VO2peak ml.min.kg) | VO2 at peak exercise was measured with Cardiopulmonary Exercise Test. | Change from baseline through study completion, an average of 4 weeks |
| First ventilatory threshold (VT1) (ml.min.kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Richard, MD | Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France | Principal Investigator |
| Thibaut Guiraud, PhD | Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France | Study Director |
| Florent Besnier, PhD | Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens-de-Gameville, France. / Institute of Cardiovascular and Metabolic Diseases, National Institute of Health and Medical Research (INSERM), UMR-1048, Toulouse, France | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31352063 | Derived | Besnier F, Labrunee M, Richard L, Faggianelli F, Kerros H, Soukarie L, Bousquet M, Garcia JL, Pathak A, Gales C, Guiraud T, Senard JM. Short-term effects of a 3-week interval training program on heart rate variability in chronic heart failure. A randomised controlled trial. Ann Phys Rehabil Med. 2019 Sep;62(5):321-328. doi: 10.1016/j.rehab.2019.06.013. Epub 2019 Jul 25. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 17, 2016 | Jul 23, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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subjects were randomly assigned to one of the two groups:
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heart rate variability analyses and echocardiography were performed by investigators blind to randomization
VO2 at VT1 was measured with Cardiopulmonary Exercise Test.
| Change from baseline through study completion, an average of 4 weeks |
| Heart Rate Recovery (beats per minute, bpm) | Heart Rate Recovery (with passive recovery) at 1, 2 and 3 minutes after peak exercise (in beats per minute, bpm) | Change from baseline through study completion, an average of 4 weeks |
| Left Ventricular Ejection Fraction (LVEF, %) | LV volumes and ejection fraction were calculated from apical recordings by modified biplane Simpson's method. | Change from baseline through study completion, an average of 4 weeks |
| premature ventricular contraction, (n/24h) | Ectopic ventricular beats were classified as isolated premature contractions, bigeminy, and salves. | Change from baseline through study completion, an average of 4 weeks |
| NT-pro-BNP, (ng/L) | blood sample analysis | Change from baseline through study completion, an average of 4 weeks |