Effect of Blood Flow Restriction on Cardiovascular Function in Elderly with Metabolic Syndrome X
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Weight and height measurement
研究概览
简要总结
The purpose of the study is to investigate the effect of aerobic exercise with Blood flow restriction training (BFR) on cardiovascular function and quality of life in hypertensive elderly patients.
Hypothesis There will be no significant effect of aerobic exercise with RBF on cardiovascular function and the quality of life in hypertensive elderly patients.
详细描述
Sixty elderly patients with metabolic syndrome X aged from 65 to 75 years old. will be selected from Al-Ahrar teaching hospital -zagazig governorate.
Study Design:
This experimental comparative control study will be performed after patients' clinical assessment who will be randomly allocated into two equal groups:
Group A (aerobic exercise with BFR group):
Thirty patients will apply moderate aerobic exercise with RBF in form of a treadmill for 30 minutes for 12 weeks (3 sessions/ week).
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
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sixty elderly patients.
- •Their ages will range from 60 to 70 years old.
- •Grade II Hypertensive patients (SBP 160-179 mmHg and/or DBP 100-109 mmHg)
- •Patients with dyslipidemia: at least one of the fasting lipid profile tests include the following results.
- •A-Total Cholestrol more than 240 (mg/dl). B-LDL Cholestrol more than 160 (mg/dl). C-HDL Cholestrol less than 40 (mg/dl). D-Triglycerides more than 200 (mg/dl).
- •'Body Mass Index: from 30: 40 kg/m2 calss I and II obesity.
排除标准
- •Severe Chest diseases (either obstructive or restrictive).
- •Clinical signs of a severe cardiac event. (eg, severe atherosclerosis, congestive heart failure),
- •Severe psychiatric or cognitive impairment, who unable to follow comment.
- •Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- •Patients with severe self-limiting illness (e.g., cancer).
- •Peripheral artery disease in lower extremities.
- •Systolic blood pressure < 180 mmHg, diastolic blood pressure more than 110 mmHg, or resting heart rate above 120 bpm.
- •Patient with uncontrolled - diabetes.
研究组 & 干预措施
Group A (aerobic exercise with BFR group)
Thirty patients will apply moderate aerobic exercise with RBF in form of a treadmill for 30 minutes for 12 weeks (3 sessions/ week).
干预措施: Aerobic exercise with BFR (Other)
Group A (aerobic exercise with BFR group)
Thirty patients will apply moderate aerobic exercise with RBF in form of a treadmill for 30 minutes for 12 weeks (3 sessions/ week).
干预措施: Aerobic training (Other)
Group B (aerobic training group)
Thirty patients will apply moderate intensity aerobic exercise without BFR for 30 minutes for 12 weeks (3 sessions/ weak).
干预措施: Aerobic training (Other)
结局指标
主要结局
Weight and height measurement
时间窗: Baseline (assessment).
Weight and height are recorded, and BMI will be calculated according to the formula: BMI = Weight (Kg) / Height (m2)
Blood pressure monitoring by (Aneroid Sphygmomanometers)
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
Aneroid sphygmomanometers were used to obtain a BP reading (Pickering TG et al., 2005). Virtually 100% of the values. From the aneroid-device were within the three-mm-Hg range recommended' by the Association for the Advancement of Medical instrumentation.
Pulse rate by Pulse oximeter
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
It is widely used to noninvasively assess arterial oxyhemoglobin saturation (SpO2).
Lipid profile
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
All patients will perform laboratory lipid profile before and after the study. The three main blood levels collected to assess for dyslipidemia is (TG, HDL-C, LDL-C and T.G) after fasting for 8-12 hours.
apolipoprotien test
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
: test to detect the risk of cardiovascular disease
time up and go test
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
A sturdy armchair with a back was placed at the end of a hallway adjacent to where height and weight measures are routinely taken in the process of rooming participants. A piece of tape was placed on the floor 3 m away from the front edge of the chair. Patients were seated in the chair with back against the chair back, arms resting on the armrests, and given general instructions about the task, including walking at a normal rather than a rapid speed. The TUG required patients to stand up out of the chair, walk 3 m, turn around, walk back to the chair, and sit down. Patients were given the following instructions: "stand up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down." The timing of the test began at the word "go," and ended when the participant was seated
Fatigue Assessment Scale
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
The FAS is a 10-item scale evaluating symptoms of chronic fatigue. In contrast to other similar measures the FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale would evaluate all aspects of fatigue, developers chose items to represent both physical and mental symptoms. Each item of the FAS is answered using a five-point scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
HeartQoL questionnaire
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
According to European Journal of Preventive Cardiology 2016 HeartQoL is a recently developed core health-related quality of life instrument for patients with coronary heart disease. The current study aims to investigate its association with patients' coronary risk profile and to provide reference values for patients with coronary heart disease
The double product (DP)
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
consisting of the SBP multiplied by the pulse rate (PR), is an index of myocardial oxygen consumption
Mean Arterial Pressure
时间窗: Baseline (assessment), and at 12 weeks post-intervention.
The definition of mean arterial pressure (MAP) is the average arterial pressure throughout one cardiac cycle, systole, and diastole. MAP is influenced by cardiac output and systemic vascular resistance, each of which is influenced by several variables. A common method used to estimate the MAP is the following formula: MAP = DP + 1/3(SP - DP)
次要结局
未报告次要终点
研究者
Karim Mohsen Abdeltawaab
Assistant Lecturer
Cairo University