Acute Effects of Different Physical Exercise Conditions in Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 主要终点
- Blood Flow
研究概览
简要总结
Peripheral arterial disease (PAD) affects over 200 million people worldwide and is caused by narrowing of the arteries. Intermittent claudication, characterized by pain when walking, is its main symptom. Despite the proven benefits of exercise, there is no optimal protocol for treatment. To analyze the effects of different exercise conditions on proteomic and physiological markers in patients with PAD and to determine their preferences regarding exercise conditions. A clinical cross-over study with four randomized experimental conditions (aerobic training, traditional strength training, circuit training and control) will be conducted. Patients with grade IIa-IIb PAD according to the Leriche-Le Fontaine scale will be recruited from the Department of Angiology and Vascular Surgery Department of the Hospital Clínico Universitario de Valladolid. In each experimental session, measurements of cardiorespiratory capacity, post-exercise oxygen debt, ankle-brachial index, blood flow, peripheral oxygen saturation, perceived exertion, heart rate variability and blood proteome changes will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The researcher responsible for analyzing the data will be blinded to the study conditions.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older.
- •Patients diagnosed with peripheral arterial disease at grade IIa or IIb according to the Leriche-Fontaine classification.
排除标准
- •Patients with dementia or cognitive impairment.
- •Patients with recent major surgery (≤12 months) or lower limb amputations.
- •Patients institutionalized in healthcare facilities.
- •Patients dependent on a wheelchair.
- •Patients with any other condition contraindicating participation in an exercise program.
研究组 & 干预措施
Aerobic exercise
Intermittent walking will be performed on a treadmill (F2W DUAL, BHFitness®, Spain). There will be 8 sets of 2 minutes in duration at an intensity equivalent to the level at which the patient experienced claudication symptoms. The recovery period between each set will be two minutes. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
干预措施: Aerobic exercise (Other)
Traditional strength exercise
Two sets will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) consisting of 6 multi-joint exercises. The recovery period after each set will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
干预措施: Traditional strength exercise (Other)
Circuit strength exercise
Two sets (rounds) will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) in a circuit consisting of 6 multi-joint exercises. The recovery time between exercises will be the minimum required to change exercises, and the recovery between sets (rounds) will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
干预措施: Circuit strength exercise (Other)
Control
Control. No intervention
结局指标
主要结局
Blood Flow
时间窗: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)
An ultrasound machine will be used to measure blood flow in the femoral artery, quantifying changes in the velocity and diameter of the artery in the lower extremity with the lowest ABI. Blood flow measurements will be conducted with the participant in a supine position. During the first experimental visit, the measurement site will be determined, where all measurements will take place. This measurement site corresponds to the common femoral artery, just below the inguinal ligament, and approximately 2 cm above the bifurcation into the superficial and deep femoral arteries.
Peripheral oxygen saturation
时间窗: Week 1 (baseline), Weeks 2-4 (during each intervention session)
Changes in peripheral oxygenation levels in the gastrocnemius will be evaluated during physical exercise. For this purpose, near-infrared spectroscopy (NIRS) will be used, which utilizes a wavelength of 700-900 nm to assess the concentration of oxygenated and deoxygenated hemoglobin and the total blood volume. The NIRS device MOXY Monitor (Moxy, Fortiori Design LLC, Minneapolis, MN, USA) will be used.
Heart rate variability
时间窗: Week 1 (baseline), Weeks 2-4 (during intervention and 24, 48, and 72 hours post-intervention)
By monitoring the heart rate of participants, heart rate variability (HRV) will be assessed, which reflects the variation in the time intervals between beats (R-R intervals) and serves as a useful tool for monitoring patient health, as it estimates the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. To evaluate HRV, a Polar H10 heart rate monitor (Polar Electro Oy, Kempele, Finland) and a mobile application, specifically Elite HRV, will be used. Heart rate variability will be monitored daily during the week leading up to the initial assessment visits. Participants will be instructed to take the measurement for the first 5 minutes after waking up and while fasting.
Proteomics
时间窗: Weeks 2-4 (5 minutes prior to exercise and 5 minutos post-intervention)
A blood sample will be collected during the last 5 minutes of the pre-session and after completing the experimental condition, just before a 15-minute post-session rest. Venous blood will be drawn from the antecubital vein and stored at 4°C to prevent clotting and minimize protein degradation. Samples will be centrifuged at 1500 g for 10 minutes at 4°C, discarding the remaining sample. Ten microliters of protease inhibitor will be added to each 1.0 ml plasma aliquot, stored at -80°C for later analysis, with only one freeze-thaw cycle permitted. All samples will be prepared within 1 hour of collection and must show no hemolysis. Peptide identification will be performed using Proteome Discoverer (version 2.1.0.81) and SEQUEST-HT, analyzing data in the Uniprot database (January 25, 2024; 20,433 reviewed entries). Identified peptides with a false discovery rate (FDR) of 1% or less will quantify the relative abundance of each protein.
次要结局
- Post-exercise oxygen debt(Weeks 2-4 (after every intervention session))
- Perceived exertion(Weeks 2-4 (right after every intervention session and 24, 48, and 72 hours post-intervention))
- Satisfaction with the type of training(Weeks 2-4 (right after every intervention session and 24 and 48 post-intervention))