Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- ambulatory blood pressure
研究概览
简要总结
The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE) training on cardiovascular function in PAD patients, and compare it with treadmill exercise (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will be allocated randomly in three experimental groups: ACE training, TE and control group. ACE and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a week, however only to perform diverse activities and group living, without any type of exercise involved. All groups will be encouraged to increase their levels of activity, as they are usually guided in medical consultations. Before and after 12 weeks of intervention, cardiovascular function, functional capacity, cognition, and quality of life will be assessed.
详细描述
Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic peripheral artery disease (PAD) due the benefits on functional capacity and quality of life, besides provoking less or no pain symptoms during the execution. This study sought to describe the protocol of a study that will analyse the effect of ACT exercise on walking capacity, cardiovascular function, cognition and quality of life in patients with symptomatic PAD.
This is a three-armed randomized, prospective, single-blind data collection, single-center, controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3 intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes, Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention, cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood pressure, heart rate variability, arterial stiffness, vascular function), functional capacity (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ], Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for intermittent claudication, handgrip test and short physical performance battery [SPPB]), cognition (executive function and memory) and quality of life (short version of world health organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be assessed.
This is the first trial to evaluate the effects of ACT on regulatory mechanisms of cardiovascular system in PAD patients. If the results are as expected, they will provide evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD stage II
- •Ankle brachial index <0.90 in one or both lower limbs;
- •Women in post-menopause phase without hormone replacement therapy
- •Not an active smoker;
- •Able to perform exercise training;
- •Patients selected to participate in the study will be only excluded if:
- •Change their medication;
- •Present any health impairment that contraindicates the practice of physical exercise during the study;
排除标准
- 未提供
结局指标
主要结局
ambulatory blood pressure
时间窗: Change from baseline in ambulatory blood pressure at 12 weeks
Systolic, diastolic and mean blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic ambulatory blood pressure monitor (Cardios, São Paulo, Brazil).
次要结局
- March in place(Change from baseline in the number of the steps at 12 weeks)
- Subjective measurement of walking capacity(Change from baseline in the walking impairment questionnaire score after 12 weeks)
- Subjective measurement of walking capacity compared to healthy subjects(Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks)
- Central blood pressure(Change from baseline in ambulatory blood pressure at 12 weeks)
- General functional capacity(Change from baseline in the Short Physical Performance Battery score after 12 weeks)
- Arterial stiffness(Change from baseline in arterial stiffness at 12 weeks)
- Overall strength test(Change from baseline in kgf of the handgrip test after 12 weeks)
- Clinic blood pressure(Change from baseline in ambulatory blood pressure at 12 weeks)
- Symptoms of intermittent claudication(Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks)
- Heart rate variability(Change from baseline in ambulatory blood pressure at 12 weeks)
- Vascular function(Change from baseline in flow-mediated vasodilation at 12 weeks)
- Walking capacity(Change from baseline in walking distance at 12 weeks)
- Specific quality of life of vascular patients(Change from baseline in the Vascular quality of life questionnaire score after 12 weeks)
- General quality of life(Change from baseline in the World Health Organization Quality of Life score after 12 weeks)