- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00315224
Sports in Hypertension of the Elderly
The Impact of Pulse Pressure on Cardiovascular Effects of Exercise Training in Hypertension of the Elderly
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Based on previous studies on sports in hypertension, we expected the intervention to result in a decrease of systolic 24h-ambulatory BP (systolic ABP) of at least 6 mm Hg in the training group with no changes in the control group.16,17 This difference was considered to be clinically relevant. A sample size of 23 in each group has 80% power to detect a difference in means of 6 mmHg assuming that the common standard deviation is 7 mmHg, a baseline systolic ABP of 140 mmHg and a two-sided p<0.05. We estimated the drop-out rate to be about 15% leading to a sample size of 27 patients per group.
Patients are recruited from our hypertension outpatient clinic. Inclusion criteria are current antihypertensive treatment, diastolic ABP ≤ 90 mmHg, age of ≥ 60 years. Prior to the exercise program, cardiac function is examined by ECG and echocardiogram. Exclusion criteria are regular engagement in physical exercise training in the past 12 weeks prior to inclusion in the study, symptomatic peripheral arterial occlusive disease, aortic insufficiency or stenosis > stage I, hypertrophic obstructive cardiomyopathy (HOCM), congestive heart failure (> NYHA II), uncontrolled cardiac arrhythmia with haemodynamic relevance, systolic office BP ≥ 180 mmHg, signs of acute ischemia in exercise ECG, change of antihypertensive medication in the past 6 weeks prior to inclusion in the study or during follow-up period. According to these criteria 54 patients are enrolled and randomized to exercise and control group.
Physical performance is assessed using a modified Bruce-protocol. Arterial elasticity is measured by pulse-wave analysis of the radial artery. Endothelium-dependent vasodilation is assessed sonographically by flow-mediated vasodilation. 24h-ABP monitoring is performed using Spacelabs 90207 monitors. The follow-up BP and vascular measurements of the training group are conducted within 2 days after the last training session.
The training program, consisting of walking on a treadmill according to an interval-training pattern, is carried out 3 times weekly for 12 weeks. If patients miss a training session, the program is prolonged until 36 workouts are carried out. The initial duration of training sessions is 30 minutes. During the first week, training consists of 5 workloads of 3 min; between workloads patients walk with half-speed for 3 min. Exercise duration is gradually increased to 4 x 5 min a day in the second week, 3 x 8 min in the third, 3 x 10 min in the fourth and 2 x 15 min in the fifth week. In the sixth and further weeks, exercise is progressively increased to 30, 32 and 36 min and is carried out without interruption. Training intensity corresponds to the speed necessary to reach a lactate concentration of 2.5 ± 0.5 mmol/l in capillary blood slightly above the aerobic threshold. Heart rate during training is controlled by a heart-rate monitor. As lactate concentration sinks below 2.0 mmol/l or exercise heart rate decreases by more than 5/min as a result of training adaptation, treadmill speed is increased by 0.5 km/h or elevation is increased by 3% to maintain training intensity. We have previously shown that this training protocol leads to a substantial increase of physical performance in short time. During training patients are continuously supervised by a physician.
Typ studie
Zápis
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Berlin, Německo, 12200
- Charite, Campus Benjamin Franklin
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
≥ 60 years antihypertensive treatment diastolic 24h-ambulatory blood pressure (ABP) ≤ 90 mmHg
Exclusion Criteria:
regular engagement in physical exercise training in the past 12 weeks symptomatic peripheral arterial occlusive disease aortic insufficiency or stenosis > stage I hypertrophic obstructive cardiomyopathy (HOCM) congestive heart failure (> NYHA II) uncontrolled cardiac arrhythmia with haemodynamic relevance systolic office BP ≥ 180 mmHg signs of acute ischemia in exercise ECG change of antihypertensive medication in the past 6 weeks or during follow-up period
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
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Decrease of 24h-ambulatory systolic blood pressure
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Sekundární výstupní opatření
Měření výsledku |
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change of diastolic blood pressure
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change of pulse pressure
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change of arterial compliance
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change of endothelium-derived vasodilation
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Timm H Westhoff, MD, Charité, Campus Benjamin Franklin, Medizinische Klinik IV, Berlin, Germany
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EA4/019/2004
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