跳至主要内容
临床试验/NCT06538454
NCT06538454招募中不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Values of systolic and diastolic blood pressure (mmHg)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Exercise training studies cannot blind therapists or participants to the intervention or exercise administred. Our study will blind the statistical analysis because we will code the data to avoid knowledge about the intervention performed and who was the participants.

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Values of systolic and diastolic blood pressure (mmHg)

时间窗: Up to end of study data collection (both stages), i.e, assesed up to 1 year

This measurement will be assessed in both stages. In the acute phase, this measurement will be performed on the participant before, after and up to one hour after the end of the training session. In the chronic phase, this measure will be performed in participant after a rest in a quiet room with temperature controlled before (baseline) and after 10 week of intervention. Futhermore, along the intervention these measure will be performed before and after training sessions.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo da Silva Gonçalves

Principal Investigator

University of Sao Paulo

研究点 (1)

Loading locations...

相似试验