Effectiveness of Combined Aerobic and Strength Training in Acute and Chronic Adaptations in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change from rest Arterial Stiffness and post effort
研究概览
简要总结
Patients with chronic heart failure (CHF) underwent to a hospital-based cardiac rehabilitation (CR) program in the Lisbon district Hospitals will be recruited. The participants will be randomized into one of the following exercise groups: A) combined exercise training with more aerobic training and less strength training (CAT); B) combined exercise training with more strength training and less aerobic training (CST). The investigators will test two proportions in combined training, CAT and CST. There hasn't been any data on the so called combined regimes, which include both aerobic exercise with HIIT and ST and the investigators will evaluate the effects of acute and chronic response.
The research project will contribute to a better understanding in several aspects that are unexplained by scientific research.
详细描述
Literature Review:CHF is the major public health problem in the world[1], highly prevalent in older individuals and a major cause of disability, hospitalizations, morbidity and mortality[2]. Generally, CHF patients have reduced exercise capacity, with main symptoms of effort intolerance, early fatigue and breathlessness[3], also exhibiting increased peripheral and central chemosensitivity, and impaired sympathovagal balance with sympathetic activation(SA) predominance[4].
Understanding the oxidative metabolism and intracellular energy transfer in both skeletal and cardiac muscle, mechanisms of endothelial dysfunction, and the role of SA and inflammatory cytokines provide possible mechanistic explanations of the pathophysiologic factors involved in the development of exercise intolerance[5,6]. It has been shown in CHF patients that increased arterial stiffness is associated with cardiovascular morbidity and mortality[7]. There are evidences that increased arterial stiffness predicts exercise intolerance in CHF patients[8].
Increased carotid IMT is associated with subclinical left ventricular(LV) myocardial dysfunction, suggesting a possible role of carotid IMT in HF risk determination [9]. CHF is associated too with endothelial dysfunction including impaired endothelium-mediated, flow-dependent dilation(FMD). Since endothelial function is thought to play an important role in coordinating tissue perfusion and modulating arterial compliance, interventions to improve endothelial dysfunction are imperative.
Systemic vasoconstriction and impaired peripheral perfusion are hallmarks in advanced CHF. While a number of factors, including increased sympathetic tone and an activated renin-angiotensin system, have been proposed to be involved in the reduced arterial vasodilatory capacity in HF, the pivotal role of the endothelium in coordinating tissue perfusion has now been recognized.
Several clinical studies have documented endothelial dysfunction of large conduit and small resistance vessels in patients with CHF. Endothelial dysfunction may affect the cardiovascular system in two ways: first, endothelial dysfunction of resistance vessels may impair peripheral perfusion, and, second, endothelial dysfunction of large conduit vessels may limit the increase in blood flow provided by the supplying large vessels and may increase impedance of the failing LV and consequently impair LV ejection fraction(LVEF). An important functional consequence of endothelial dysfunction is the inability to release nitric oxide(NO) in response to physiological stimuli such as increases in flow, reflecting impaired FMD[10]. Conversely, chronically increased blood flow enhances the release of NO in experimental models, by upregulation of NO synthase, the enzyme that uses L-arginine to generate NO. The intermittent increases of blood flow by physical training may increase the capability of the endothelium to release NO and therefore may restore endothelial function in patients with CHF who are usually subjected to a limited degree of physical activity[5]. The dysfunctional endothelium contributes to increased vascular stiffness and impaired arterial distensibility, augmenting myocardial damage[10].
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHF patients; receiving optimal medical therapy for CHF (including an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker and a beta-blocker unless a contraindication is evident) with a stable condition for more than 1 month (no hospitalization for heart failure (HF), no change in medication, and no change in New York Heart Association (NYHA) functional class.
排除标准
- •If they are younger than 18 years or are unable to sign informed consent; unstable angina pectoris; and orthopedic or neurological limitations to exercise.
研究组 & 干预措施
Combined Aerobic Training
The subjects will perform in ST part, always only 1 set in the 6 machines early mentioned. During the first and second week they will do 12 repetitions at 40% - 50% of 1 RM. In the third and fourth week progress to 10 repetitions at 60%-70% of 1 RM, and in the second and third month, 8 repetitions at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of 10 interval training periods (2 min of high intensity at 85% - 90% of heart rate reserve (HRreser) and 9 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 5 intervals of HIIT, and in the second and third months they are doing the 10 stages of HIIT.
干预措施: Combined Strength Training (Other)
Combined Strength Training
During the first and second week subjects will perform 1 sets with 12 repetitions at 40% - 50% of 1 RM in the 6 machines mentioned before. In the third and fourth week strength exercises progress to 2 sets of 10 repetitions, at 60%-70% of 1 RM, and in the second and third month consists of 3 sets at 8 repetitions, at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of of 5 interval training periods (2 min of high intensity: 85% - 90% of HRreser) and 4 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 3 intervals of HIIT, and after the third/fourth week they are doing the 5 stages of HIIT.
干预措施: Combined Aerobic Training (Other)
结局指标
主要结局
Change from rest Arterial Stiffness and post effort
时间窗: Assessment before session in 15 minutes rest and after session at 5, 15 and 30 minutes pos effort
Arterial stiffness will be measured by pulse wave velocity(PWV) obtained by applanation tonometry will be measured during a 15 and 30min rest.A single operator locates the arteries on the right side of the body and mark the point for capturing the corresponding pressure curves with 2 specific pressure sensitive transducers. The distance between the carotid and femoral, radial and distal posterial tibial arteries will be measured directly and entered into the Complior Analyse software. Right brachial blood pressure will be measured and entered in software, and then signal acquisition is launched. When the operator observes 10 carotid pulse wave forms of at least90% quality showed on the software, pressure curves will be recorded. Values obtained from the carotid to femoral artery, carotid to radial artery and carotid to distal posterial tibial artery are taken as indices of central/aortic, upper and lower limb arterial stiffness, respectively.
Change from Baseline Arterial Stiffness at 3 months
时间窗: At baseline and 3 months after Cardiac Rehabilitation
Arterial stiffness will be measured by pulse wave velocity(PWV) obtained by applanation tonometry will be measured during a 15 and 30min rest.A single operator locates the arteries on the right side of the body and mark the point for capturing the corresponding pressure curves with 2 specific pressure sensitive transducers. The distance between the carotid and femoral, radial and distal posterial tibial arteries will be measured directly and entered into the Complior Analyse software. Right brachial blood pressure will be measured and entered in software, and then signal acquisition is launched. When the operator observes 10 carotid pulse wave forms of at least90% quality showed on the software, pressure curves will be recorded. Values obtained from the carotid to femoral artery, carotid to radial artery and carotid to distal posterial tibial artery are taken as indices of central/aortic, upper and lower limb arterial stiffness, respectively.
Change from rest Intima-Media Thickness and post effort
时间窗: Assessment before session in 15 minutes rest and after session at 5, 15 and 30 minutes pos effort
Carotid intima media thickness(cIMT) will be defined as the distance between the leading edge of the lumen-intima interface to the leading edge of the media-adventitia interface of the far wall of the right carotid artery using an ultrasound scanner. cIMT is automatically measured, and distension curves are acquired within a segment of the carotid artery about 1cm before the flow divider, where the operator places the region of interest. To evaluate the acute effects of ExT, at the pre-exercise measurement at 5,15and 30min rest, blood pressure(BP) was measured twice on the right upper arm in a dorsal decubitus position. The final measured value was used for the analysis. Immediately after measuring BP. Post-exercise measurement was carried out with the same methods. From this test, the investigators will study the diameter and distensibility of the artery,cIMT, PWV, brachial blood pressure, and the alpha and beta index.
Change from Baseline Echocardiogram at 3 months
时间窗: At baseline and 3 months after Cardiac Rehabilitation
A resting transthoracic echocardiogram will be performed with MyLab Alpha, ESAOTE, Italy. The exam will be performed by the echocardiography laboratory cardiologists, who will be blinded to experimental protocol and group randomization, with the usual measurements of systolic and diastolic function, particularly the calculation of LVEF by Simpson's formula, telediastolic and telessystolic volumes and diameters, doppler analysis of the transmitral flow, tissue doppler and quantification of mitral valve regurgitation.
Change from Baseline Cardiopulmonary Exercise Test at 3 months
时间窗: At baseline and 3 months after Cardiac Rehabilitation
This test will be performed with the subjects in a non-fasting condition and under the regular medication. A symptom-limited ramp incremental CPET, will be performed on a cycle ergometer with breath-by-breath gas exchange measurements. Each patient will be encouraged to exercise to exhaustion. Patients will continue seated on the cycle ergometer as soon as they stop, while recovery measurements are taken. Blood pressure will be continuous recorded Peak oxygen capacity will be considered the highest attained VO2 during the final 30 sec of exercise and ventilator AT will be estimate by the V-slope method. The recovery period will continue until 6 min after peak effort. All patients should achieve a respiratory exchange ratio of \>1.1. We will study, the HR max and recovery at 1st and 3rd min, the VO2 peak, respiratory exrespiratory exchange ratios, respiratory quotient, ventilatory anaerobic threshold, the ventilatory equivalent for O2 and CO2 .
Change from Baseline Intima-Media Thickness at 3 months
时间窗: At baseline and 3 months after Cardiac Rehabilitation
Carotid intima media thickness(cIMT) will be defined as the distance between the leading edge of the lumen-intima interface to the leading edge of the media-adventitia interface of the far wall of the right carotid artery using an ultrasound scanner. cIMT is automatically measured, and distension curves are acquired within a segment of the carotid artery about 1cm before the flow divider, where the operator places the region of interest. To evaluate the acute effects of ExT, at the pre-exercise measurement at 5,15and 30min rest, blood pressure(BP) was measured twice on the right upper arm in a dorsal decubitus position. The final measured value was used for the analysis. Immediately after measuring BP. Post-exercise measurement was carried out with the same methods. From this test, the investigators will study the diameter and distensibility of the artery,cIMT, PWV, brachial blood pressure, and the alpha and beta index.
次要结局
- Change from Baseline Funtional Physical Fitness Tests at 3 months(At baseline and 3 months after Cardiac Rehabilitation)
- Change from Baseline Isometric Strength at 3 months(At baseline and 3 months after Cardiac Rehabilitation)
- Change from Baseline Body Composition- Dual Energy Radiographic at 3 months ABSORPTIOMETRY(At baseline and 3 months after Cardiac Rehabilitation)
- Change from Baseline Maximal Strength at 3 months(At baseline and 3 months after Cardiac Rehabilitation)
- Change from Baseline Quality of Life Questionnaire at 3 months(At baseline and 3 months after Cardiac Rehabilitation)
- Change from Baseline Objective Measured Physical Activity at 3 months(At baseline and 3 months after Cardiac Rehabilitation)
研究者
Maria Helena Santa-Clara Pombo Rodrigues
Assistant Teacher
University of Lisbon