- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03064256
Aerobic Physical Training and Heart Rate Variability in Hypertersion
EFFECT OF AEROBIC PHYSICAL TRAINING WITH DETERMINED INTENSITY FOR THE PROTOCOL OF DOUBLE EXHAUSTIVE EFFORTS IN THE AUTONOMICAL MODULATION OF THE HEART FREQUENCY OF PATIENTS WITH SYSTEMIC ARTERIAL HYPERTENSION
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The study was designed to compare changes in the cardiovascular, hemodynamic and metabolic variables of hypertensive patients who received aerobic physical training with intensity determined by the DENE protocol with that of patients who received routine ambulatory care 12 weeks after entering the study.
Sixty-three hypertensive men and women, divided into the intervention group (GI) (n=42) and the control group (n = 21) participated in the study.
All procedures were performed by trained researchers and qualified staff and the evaluations and intervention were performed at the specialty medical outpatient clinic.
After agreeing to participate in the study, we collected sociodemographic and clinical data, body mass index (BMI), waist circumference (WC) and waist / hip ratio (WHR). The participants were submitted to the cardiopulmonary exercise test (TECP), to evaluate the peak oxygen consumption (VO2peak), oxygen pulse and double product. Between one and seven days after TECP, consecutive heart rate intervals (iRR) were recorded for evaluation of autonomic heart rate modulation using a Polar model RS800CX (Polar Electro Co.Ltda Kempele, Finland). . The DENE protocol for determining the intensity of the training was applied in the GI to determine the training intensity in the treadmill. Intervention participants underwent supervised aerobic physical training at the pre-determined intensity, which consisted of three weekly sessions, lasting one hour, over a period of 12 weeks. Control participants receive routine care from the outpatient clinic for the same period. At the end of the 12 weeks, measures, recording of the iRR intervals, oxygen pulse, double product, BMI, waist circumference (AC), hip circumference (QC) and waist / hip ratio (WHR) were obtained. All subjects were previously informed about the procedures Signed a free and informed consent form. The project was approved by the Commission of Research Committee of the Institution with the number 086.096 / 14.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- SBP ≤ 180 mmHg and DBP ≤ 110 mmHg)
- low risk for physical training.
Exclusion Criteria:
- obesity III
- musculoskeletal conditions
- peripheral neuropathy
- Parkinson's disease.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Physical training program
Intervention participants are submitted to supervised aerobic physical training at the predetermined intensity, which is composed of three weekly sessions, lasting one hour, over a period of 12 weeks. All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise. |
Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks.
and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility
All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit).
The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
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Žádný zásah: Control Group
Control participants receive routine outpatient care for a 12-week period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Heart rate variability will be measured by nonlinear methods in hypertensive patients to observe changes in baseline values after 12 weeks.
Časové okno: Finalized study (12 weeks)
|
A heart rate meter RS800CX (Polar Electro Co.Ltda.
Kempele, Finland) is used to obtain HR and R-R (iR-R) intervals.
The iR-Rs are captured from a tape with a coded transmitter placed in the chest region at the 5th intercostal space and transmitted to the cardiofrequency meter where they are recorded
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Finalized study (12 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The peak oxygen consumption (mL / kg · min) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Časové okno: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine peak oxygen consumption to exercise .
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Finalized study (12 weeks)
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The double product (mmHg) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Časové okno: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine double produc to exercise .
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Finalized study (12 weeks)
|
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The oxigen pulse (ml/heart rate) will be measured by ergospirometry in hypertensive patients to observe changes in baseline values after 12 weeks.
Časové okno: Finalized study (12 weeks)
|
Cardiopulmonary exercise test used to determine oxigen pulse to exercise .
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Finalized study (12 weeks)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 865.096
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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