Exercise in Patients With Atrial Fibrillation: Effect of Different Types of Exercise on the Burden of the Pathology, on the Biochemical Profile, and on the Functional Capacity of the Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Concentration of proteins in blood (proteome).
研究概览
简要总结
Atrial fibrillation (AF) significantly affects quality of life and increases the demand for medical care of those affected. It is very important to identify triggering factors, such as oxidative stress or N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as to identify potential biomarkers through plasma analysis. At the same time, it is essential to establish adequate training and rehabilitation programs, which would result in a decrease in hospitalizations and the health care costs associated with the pathology. Current cardiac rehabilitation programs based on physical exercise, especially moderate intensity continuous training (MICT), have demonstrated effectiveness. MICT improves cardiorespiratory fitness and quality of life in patients with AF. However, high-intensity intervallic training (HIIT) has shown superior benefits in these variables.
Although HIIT traditionally has an aerobic focus, a variant called high-intensity functional training (HIFT) is suggested that incorporates muscle strengthening exercises recommended in the guidelines for AF management. This innovative modality seeks to achieve cardiovascular and neuromuscular adaptations simultaneously, with a high transfer to daily activities. Despite its potential, the effects at the functional, molecular and clinical levels in patients with AF are unknown. The purpose of the study is to determine the benefits of HIFT on molecular, functional and clinical variables in patients with AF, and to compare these benefits with those achieved with HIIT and the usual care and recommendations in current clinical practice.
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 (Outcomes Assessor)
盲法说明
The evaluators of the patients and the person analysing the data will be blinded to the patient's group allocation and te corresponding codes.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent atrial fibrillation.
- •Age between 18 and 80 years.
- •Sedentary lifestyle.
- •Signed informed consent.
排除标准
- •Permanent atrial fibrillation.
- •Moderate to severe left ventricular dysfunction.
- •Moderate to severe left valvulopathy.
- •Severe pulmonary hypertension.
- •Ischemic heart disease with incomplete revascularization.
- •Arrhythmogenic cardiomyopathy.
结局指标
主要结局
Concentration of proteins in blood (proteome).
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Venous blood samples are collected from the antecubital vein and kept at 4°C until preparation to avoid clotting and minimise protein degradation. Samples are centrifuged at 1500 g for 10 minutes at 4°C. Samples shall are stored at -80°C for subsequent analysis and only one freeze-thaw cycle shall be allowed. All samples shall are prepared within 1 hour of sample collection and show no signs of haemolysis. The protein concentrarion will be analyzed (μg/ml).
Oxidative stress status
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Oxidative stress is measured through the analysis of plasma oxidative stress biomarkers concentrations in pg/ml.
Cardiac function: concentrations (pg/ml) of NT-proBNP (type B natriuretic peptide).
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Measurement of cardiac dysfunction is analyzed through the presence of plasma markers of cardiac injury (NT-proBNP; pg/ml).
Maximal strength of upper and lower extremity muscles.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Maximal strength of upper and lower extremity muscles from one concentric repetition maximum (1RM) of half squat and bench press will be assessed (maximal strength). Measurements in weight lifted and the number of times. Maximum Repetition or 1RM is the maximum weight (kg) you can move in just one time.
Functional variables: power strength by bar displacement
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in bar displacement in centimeter (cm).
Functional variables: power strength by propulsive velocity
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Mean propulsive velocity (in meter per second).
Functional variables: power strength
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Average power (in watts).
Functional variables: Handgrip strength.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in the manual dynamometer measurements (in kg).
Functional variables: Assessment of cardiorespiratory capacity.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in measurements by a treadmill. The following variables will be assessed before and after the cardiorespiratory capacity measurement: 1. Gas exchange analysis (VO2, VCO2), in ml·kg-1·min-1. 2. Maximum speed in treadmill (km/h). 3. Blood pressure (systolic pressure and diastolic pressure in mm Hg). 4. Heart rate (bpm). 5. Rate of perceived exertion (RPE) using a RPE-CR10 scale.
Functional variables: Assessment of functional capacity (6MWT).
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in six-minute walk test (6MWT): number of laps around the hallway and the additional distance covered on the last lap if it is not completed using the markings in the hallway. The outcome measure is quantified in meters.
Functional variables: Levels of physical activity
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
GT3X+ accelerometers estimate physical activity levels based on the accelerometer output in units called "counts per minute".
Clinical variables: Short Form-36 Health Survey (SF-36).
时间窗: 0 weeks, 13 weeks, 24 weeks.
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process. The SF-36 offers a choice of recall format at a standard (4 week) or acute (1 week) time frame. Likert scales and yes/no options are used to assess function and well-being on this 36-item questionnaire. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value.
Clinical variables: Atrial fibrillation burden.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in electrocardiogram (electrical signal from the heart to detect different heart conditions).
Clinical variables: Atrial fibrillation burden (subjective measurement).
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire: palpitations, dyspnea, fatigue and limitations in daily activities. AFEQT evaluates health-related quality of life (HRQoL) and provides an overall score; plus scores for symptoms, daily activities, treatment concerns, and treatment satisfaction. 20 questions on 7-point Likert scale Overall or subscale scores range from 0-100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).
Clinical variables: Arterial stiffness.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in the images of the right common carotid artery are obtained using an ultrasound.
Clinical variables: Heart rate variability.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
Changes in the variation in the time intervals between heartbeats (R-R intervals).
Clinical variables: Vascular dysfunction.
时间窗: 0 weeks, 2 weeks, 13 weeks, 24 weeks.
The cardio-ankle vascular index (CAVI) is a new index of the overall stiffness of the artery from the origin of the aorta to the ankle. CAVI values range from 3 to 18. Depending on the cut-off values. Standardized values established by the manufacturer, a value \< 8 is considered normal, between 8 and 9 is borderline, and 9 is high and indicates advanced atherosclerosis.
次要结局
未报告次要终点
