Effect of Single-versus Double-limb Cycling Exercise on Blood Flow in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Blood flow velocity by Doppler
研究概览
简要总结
This study will be conducted to investigate the effect of single limb cycling exercise and the effect of double limb cycling exercise on blood flow in patients with peripheral artery disease and compare between both effects.
详细描述
Global populations are undergoing a major epidemiological transition in which the burden of atherosclerotic cardiovascular diseases is shifting rapidly from high-income to low-income and middle-income countries (LMICs). Peripheral artery disease (PAD) is no exception, so that greater focus is now required on the prevention and management of this disease in less-advantaged countries (Gerry et al., 2017) PAD prevalence and incidence are both sharply age-related, rising >10% among patients in their 60s and 70s. With the aging of the global population, it seems likely that PAD will be increasingly common in the future. Prevalence seems to be higher among men than women for more severe or symptomatic disease (Michael et al., 2015).
PAD causes leg pain, impaired health-related quality of life, immobility, tissue loss and a high risk of major adverse events, including myocardial infarction, stroke, revascularization, amputation and death. The drug cilostazol, exercise therapy and revascularization are the current treatment options for the limb symptoms of PAD, but each has limitations (Jonathan et al., 2022) Few studies conducted the importance of active and passive movements and aerobic exercises for Cardiovascular especially peripheral artery disease patients as mentioned previously, thus the aim of this study is to conduct single limb cycling exercise and double limbs cycling exercise to PAD patient to determine the effect of cycling on blood flow velocity and which is more effective and leads to more benefits compared to the control group.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate PAD ( ABI ranges from less than 0.90 to 0.50)
- •Intermittent claudication / Typical claudication
- •Their age will be ranged from 50_60 years old.
- •Quitting smoking for more than 3 months
- •Body mass index (BMI) from 25.0 to 29.9kg/m2.
排除标准
- •Patients with uncontrolled pulmonary disease.
- •Patients with vascular severe complication as critical limb ischemia(ABI less than 0.5)
- •Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure.
- •Patients with severe musculoskeletal problems (e.g., severe knee osteoarthritis or post knee replacement surgeries).
- •Any patients who missed more than two weeks of the program or want to terminate the program.
结局指标
主要结局
Blood flow velocity by Doppler
时间窗: baseline
Blood flow (velocity) and circulation: which will be measured by the doppler ultrasonogrophy at the begining and at the end of the study. \- Doppler ultrasonogrophy of the lower extremity arteries, from common femoral to pedal arteries peak systolic velocity (PSV) recorded in meters per second (Ugwu.,et al .,2021 ) .The normal peak systolic velocity (PSV ) in peripheral lower limb arteries varies from 45-180 cm/s . Severe arterial disease manifests as a PSV in excess of 200 cm/s , monophasic waveform and spectral broading of the doppler wave form .
次要结局
- Walking impairment questionnaire(baseline)
- Functional capacity test (6 Min walk test )(baseline)
- The ankle -brachial index test(baseline)
研究者
Merna Marwan Mohamed Kamal
physical therapist
Cairo University