Effects of Self-selected Walking Exercise Intensity on Adherence, Functional Capacity and Cardiovascular Risk Indicators in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cerebral perfusion
研究概览
简要总结
Although the benefits of supervised walking training in patients with peripheral arterial disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the main problems found in this type of protocol is low adherence to training, which is possibly related to pain during training. In addition, little is known about the impact of performing exercise with pain on cerebral blood flow and cardiovascular health indicators. Thus, the objective of the present study will be to analyze the acute effects of walking exercise with self-selected intensity on the cardiovascular health indicators of patients with PAD. Therefore, 17 patients with PAD will undergo three experimental sessions: exercise with self-selected intensity, exercise until maximum pain and control. The responses of the cardiovascular variables (heart rate variability, blood pressure, heart rate, arterial stiffness and endothelial function) will be obtained before and after the sessions. In addition, during the session cardiovascular responses (cerebral blood flow, blood pressure and heart rate), perceptual and affective responses, as well as information about the exercises performed during the session will be obtained. The responses before and after exercise will be analyzed using the two-way analysis of variance for repeated measures (ANOVA) and the Newman-Keuls post-hoc test. The value of P <0.05 will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral artery disease in one or both limbs (ankle brachial index <0.9);
- •Claudication symptoms in six-minute walking test;
- •who can walk at least 90 meters without interruption;
- •that have physical conditions to perform the exercise sessions;
排除标准
- •do not finish three experimental sessions;
结局指标
主要结局
Cerebral perfusion
时间窗: Change from baseline at 30 minutes after the beginning of the exercise.
The cerebral perfusion at rest will be obtained by a transcranial doppler (TCD, Spencer Technologies, United States). To this end, patients will wear a helmet (Marc 600; Spencer Technologies, United States) capable of bilaterally attaching two 2 MHz ultrasound probes to the temporal window. With a method similar to that of an extracranial doppler, the transcranial doppler is capable of capturing the speeds of brain flows. The flow velocities of the middle cerebral artery will be measured bilaterally for 5 minutes, with patients at rest.
次要结局
- Subjective perceived effort(Change from baseline at 35 minutes after the beginning of the exercise.)
- Cognitive function 2(Change from baseline at post-intervention, after 1 hour and 10 minutes.)
- Brachial blood pressure(Change from baseline at 30 minutes after the beginning of the exercise.)
- Heart rate variability(Change from baseline at post-intervention, after 20 minutes.)
- Feeling Scale(Change from baseline at 35 minutes after the beginning of the exercise.)
- Cognitive function(Change from baseline at post-intervention, after 1 hour.)
研究者
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho