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Идёт набор NCT06538454

Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

Без фазы С лечением Arterial Hypertension Postmenopausal; Menorrhagia Cardiovascular Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Resistance training.
Кому может быть актуально
Состояния в реестре: Arterial Hypertension, Postmenopausal; Menorrhagia, Cardiovascular Diseases. Базовые параметры: 50 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Acute and Chronic Effects of Resistance Training Intensity on Cardiovascular Parameters of Postmenopausal Women With Systemic Arterial Hypertension

Обзор

The goal of this clinical trial is to understand about the effects of resistance training (RT) intensity on cardiovascular parameters in postmenopausal women with systemic arterial hypertension (SAH). The main research questions are: * Does the intensity of RT impact blood pressure (BP) in postmenopausal women with SAH? * How does RT intensity affect heart rate (HR) and their variability (HRV), endothelial function (EF), and nitric oxide (NO) biomarker synthesis in this population? * What are the effects of RT intensity on affectivity and rate of perceived exertion (RPE)? Researchers will compare two different intensities of RT (60% of the load for 1 repetition maximum \[1RM\] and 80% of 1RM) to determine their effects on the mentioned cardiovascular and perceptual parameters. Participants will: In the acute experiment: * Perform the same RT session in a crossover design, training with 60% of 1RM in one condition and 80% of 1RM in another condition * Have BP, HR, and HRV measured before, immediately after, and for one hour post-session * Report affectivity before each session and at the end, along with RPE In the chronic experiment: * Be randomized into two groups: one training with 60% of 1RM and the other with 80% of 1RM * Undergo a 10-week intervention period with evaluations before, during, and after the intervention * Have BP, HR, affective responses, and RPE measured at multiple time points * Have EF, HRV, and salivary concentrations of NO biomarkers assessed before and after the intervention

Подробное описание

Physical training has been recommended as a non-pharmacological therapeutic strategy that can promote improvements in blood pressure levels in patients with systemic arterial hypertension (SAH). Resistance training (RT) has emerged due to the various benefits it promotes, including reducing blood pressure (BP) in this population, as improvements in heart rate variability (HRV) and endothelial function (EF). Guidelines suggest an intensity between 50% and 80% of 1 repetition maximum (1RM) in RT, reflecting a range of maximum repetitions between 9 and 26. However, there is a lack of studies that have made a direct comparison of the effect of different intensities in cardiovascular parameters of these patients. Therefore, the objective of this study will be to evaluate, acutely and chronically, the effect of RT intensity on BP, heart rate (HR), HRV, endothelial function, salivary concentrations of nitric oxide (NO) biomarker synthesis, also affectivity and rate of perceived exertion (RPE) of postmenopausal women with SAH. The study will be conducted in two stages, with two experiments: one acute and one chronic. In the acute experiment, with a crossover design, participants will perform the same RT session (with the order of these sessions being random), but in one condition they will train with 60% of 1RM and in another with 80% of 1RM. BP, HR and HRV will be measured before, at the end and for one hour after the session (hypotensive effect of the exercise). Affectivity will be measured before each test and at the end together with PSE. In the chronic study, participants will be randomized to one group that will train with 60% of 1RM and another group that will train with 80% of 1RM. Before, during and after the intervention, which will last 10 weeks, participants will be evaluated for BP, HR, affective responses and RPE, with EF, HRV and salivary concentrations of NO biomarkers measured before and after the intervention.

Вмешательства

  • Поведенческое Resistance training
    The exercises will be the same in both stages: squat, bench press, stiff, rowing, hip thrust and shoulder press. Futhermore, the rest interval (2 minutes) and the exercise order (alterning upper and lower limbs) also will be the same in the stages. In the chronic experiment, the resistance training will be carried for 10 weeks with 2 weekly sessions in alternate days. The sets in both groups will be carried close to muscle failure. The difference between groups is the intensity, who reflects t

Первичные конечные точки

  • Values of systolic and diastolic blood pressure (mmHg) [Срок оценки: Up to end of study data collection (both stages), i.e, assesed up to 1 year]
Вторичные конечные точки (5)
  • Values of heart rate variability (ms) [Срок оценки: Up to end of study data collection (both stages), i.e, assesed up to 1 year]
  • Endothelial function (Flow mediated dilatation %) [Срок оценки: Up to end of chronic experiment (baseline and post-intervention values), assesed up to 1 year]
  • Salivary concentrations of nitric oxide (mmol/L) [Срок оценки: Up to end of chronic experiment (baseline and post-intervention values), i.e, assesed up to 1 year]
  • Rate of perceived exertion (scale from 1 to 10) [Срок оценки: Up to end of study data collection (both stages), i.e, assesed up to 1 year]
  • Affectivity (scale from -5 to +5) [Срок оценки: Up to end of study data collection (both stages), i.e, assesed up to 1 year]

Критерии участия

Критерии включения

  • Women with 50 to 65 old years;
  • Postmenopausal diagnosis (amenorrhea for 12 months or more);
  • Previous diagnosis of hypertension and treat with medications;
  • Physically inactive.

Критерии исключения

  • History of other cardiovascular problems (heart failure, heart attack, stroke, etc);
  • Grade II obesity (BMI ≥ 35 kg/m²);
  • Medications (beta-blockers and/or non-dihydropyridine calcium channel blockers);
  • Systolic blood pressure at rest above 160 mmHg and/or dyastolic blood presure above 105 mmHg;
  • Unable to perform resistance exercise due to musculoskeletal or cognitive reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Laboratório de Fisiologia do Exercício e Metabolismo — Ribeirão Preto

Идентификаторы

NCT: NCT06538454 · LOADPMW5065

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗