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临床试验/NCT06617117
NCT06617117已完成不适用

Dynamic Acute Responses of Different Intensity-dependent Exercises on the Autonomic and Vascular Systems in People with Coronary Artery Disease

Egas Moniz - Cooperativa de Ensino Superior, CRL2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Central blood pressure

研究概览

简要总结

High blood pressure (BP) is a major risk factor for coronary artery disease (CAD), with 30-70% of CAD patients having elevated BP. The conventional method of measuring BP in the arm (brachial BP) may miss some cases, as individuals can have normal brachial pressure but elevated central systolic pressure, which is a more critical predictor of cardiovascular events. Lowering BP is a key objective in cardiac rehabilitation programs.

Examining BP responses after a single bout of exercise could help predict how effectively exercise lowers BP over time. There is a well-established reduction in BP, known as post-exercise hypotension (PEH), which occurs after exercise. This drop is typically around 8 to 9 mmHg and is observed in individuals with and without hypertension. However, it may not occur in people with CAD. The reason for this difference is unclear but may relate to individual variability in exercise responses.

No research has closely examined individual responses to PEH in people with CAD, and it remains unclear whether exercise affects central and brachial BP differently, as some medications do. Additionally, exercise intensity may influence the magnitude of the BP reduction post-exercise. Higher-intensity exercise tends to cause a more significant BP drop, both in hypertensive and non-hypertensive individuals, typically within 20 to 60 minutes post-exercise.

Therefore, the present study aimed to determine the acute effects of combined exercise at different intensities on central and brachial blood pressure in individuals with and without coronary artery disease.

The key research questions were:

  1. Is the BP response of central and brachial arteries to acute combined exercise similar? How does coronary artery disease influence these BP responses? Is there individual variability among people with CAD?
  2. Does high-intensity exercise, compared to moderate-intensity exercise, produce more pronounced changes in BP in the post-acute exercise period?

All participants were asked to:

Complete two combined exercise sessions - one moderate- and one high-intensity bout. The order of the sessions was randomly assigned, similar to flipping a coin.

BP was measured before and after each acute exercise bout in the laboratory. The researchers compared central and brachial BP responses between exercise intensities (high vs. moderate) and populations (individuals with and without CAD).

详细描述

This study was designed as a randomized cross-over, repeated measures experiment. All participants underwent two combined exercise sessions of varying intensities, specifically high (HIGH) and moderate (MOD), in a randomized sequence (http://www.randomizer.org/). Before the exercise sessions, all participants underwent both cardiopulmonary exercise testing and 1RM testing, followed by a DEXA scan during a subsequent visit to the laboratory. Each participant completed all experimental sessions consistently at the same time of the day, specifically in the mornings, with at least 48h between sessions to reduce diurnal variation. Post-exercise measurements were conducted at 5, 15 and 30 min after exercise. Participants reported to the laboratory in a fasted state (≥ 4h), and refrained from vigorous exercise, vitamin supplements, and foods/beverages containing caffeine and alcohol for at least 12 h preceding each experimental session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

盲法说明

Outcomes will be assessed by the same experts in every time point. Participants and evaluators will be blinded until arrival of the participant for the first experimental condition.

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for the coronary artery disease group:
  • Middle-aged and older adults with stable coronary artery disease (over 55 years old)
  • Inclusion criteria for the control group:
  • Aged-matched healthy adults free of cardiovascular, respiratory, or metabolic disease and with no more than 2 traditional risk factors.
  • Physically active defined as engaging in exercise at least 3 times per week over the past 6 months

排除标准

  • for both groups:
  • Cognitive impairment
  • Pulmonary disease
  • Uncontrolled atrial or ventricular dysrhythmia
  • Disability or mental illness
  • Extra-cardiac disease

结局指标

主要结局

Central blood pressure

时间窗: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise

Central systolic blood pressure (cSBP) was measured using non-invasive carotid tonometry (Complior, ALAM Medical) with participants in a supine position. Carotid waveforms were calibrated from brachial diastolic BP (bDBP) and mean arterial pressure (2/3 bDBP + 1/3 bSBP), assumed constant throughout the vascular system. A single operator performed 2 repeated measurements on the right side, each with 10 waveforms of higher than 90% quality, and the average was used. The pressure from wave reflection on SBP was derived as the difference between bSBP and cSBP.

Brachial blood pressure

时间窗: Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise

Brachial Blood pressure was measured in the supine position using an Omron sphygmomanometer after a 10-min rest. Hypertension was defined per ESH guidelines (bSBP ≥140 mmHg and/or bDBP ≥90 mmHg).

次要结局

  • Carotid femoral pulse wave velocity (cfPWV)(Baseline, before acute combined exercise/applanation tonometry; 5, 15 and 30 minutes after acute combined exercise)

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

研究点 (2)

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