An interventional study of Aerobic exercise and Traditional strength exercise in Aerobic Physical Exercise, Traditional Strength Exercise and Circuit Strength Exercise, sponsored by European University Miguel de Cervantes. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by European University Miguel de Cervantes · Not applicable, Interventional, and Treatment
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 16 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →European University Miguel de Cervantes is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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).
Other: Aerobic 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).
Other: Traditional 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).
Other: Circuit strength exercise
Control. No intervention
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).
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).
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).
Blood Flow
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.
Time frame: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)
Peripheral oxygen saturation
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.
Time frame: Week 1 (baseline), Weeks 2-4 (during each intervention session)
Heart rate variability
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.
Time frame: Week 1 (baseline), Weeks 2-4 (during intervention and 24, 48, and 72 hours post-intervention)
Proteomics
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.
Time frame: Weeks 2-4 (5 minutes prior to exercise and 5 minutos post-intervention)
Post-exercise oxygen debt
Post-exercise oxygen debt (EPOC) will be calculated every minute for 12 minutes following the completion of exercise using the following formula: EPOC (L·min-¹) = post-exercise VO2 (L·min-¹) - resting VO2 (L·min-¹). Subsequently, EPOC will be converted into energy expenditure with the conversion of 1L of O2 = 4.64 kcal to exclude the rapid glycolytic resynthesis of adenosine triphosphate (ATP) as part of the conversion of O2 consumption into energy expenditure (EE).
Time frame: Weeks 2-4 (after every intervention session)
Perceived exertion
During the four experimental conditions, perceived exertion will be monitored using the Rating of Perceived Exertion (RPE) scale. The RPE will be recorded after each set or circuit round. Immediately after completing the last set of each condition, participants will be asked to indicate their perceived exertion for the entire session. Scales go from 0 (no exertion) to 10 (maximal exertion possible).
Time frame: Weeks 2-4 (right after every intervention session and 24, 48, and 72 hours post-intervention)
Satisfaction with the type of training
At the end of each session, satisfaction will be evaluated using a numerical scale from 0 to 10, where the highest score indicates maximum satisfaction with the type of training.
Time frame: Weeks 2-4 (right after every intervention session and 24 and 48 post-intervention)
Levels of physical activity.
Physical activity levels will be evaluated using the International Physical Activity Questionnaire (IPAQ), consisting of 7 questions for stratifying activity levels. Additionally, five GT3X+ accelerometers, updated to Firmware v1.9.2, will estimate physical activity. Each participant will wear the accelerometer securely on their right hip for one week, secured with an elastic belt. The ActiGraph GT3X+ (ActiGraph, Pensacola, Florida, USA) is lightweight (19 g), compact (4.6 × 3.3 × 1.5 cm), and features a rechargeable lithium polymer battery. It includes a solid-state triaxial accelerometer that collects data in three axes: vertical (Y), horizontal (X), and depth (Z). The device measures accelerations from -6 to 6 Gs and digitizes the output with a 12-bit analog-to-digital converter (ADC) at up to 100 Hz. The signal is filtered, and output is provided in "counts," reflecting the amplitude and frequency of movements over time.
Time frame: Week 1 (baseline)
Ankle-brachial index (ABI)
A Doppler ultrasound machine with spectral wave analysis (Hadeco®) will be used to obtain systolic pressures in the right brachial artery, the dorsal artery of the foot, and the posterior tibial artery. To maximize accuracy, each pressure will be measured twice. The ankle-brachial index for each leg will be calculated by taking the ratio of the systolic pressure of the anterior or posterior tibial artery (whichever is higher) to the systolic pressure of the highest humeral artery (right or left). Normal values are considered to be 1.2-0.9 mmHg. A value above 1.2 mmHg will indicate arterial calcification, while a value below 0.9 mmHg will be considered pathological.
Time frame: Week 1 (Baseline)
Cardiorespiratory capacity
The mean and peak values for gas exchange will be recorded in ml/kg·min. The gas analyzer used in this study is the Cortex Metalyzer 3B (Leipzig, Germany). A submaximal incremental treadmill walking test will be conducted under constant monitoring with a heart rate monitor and a portable gas analyzer. This test will be performed at a constant speed of 3.2 km/h, with 2% increases in incline at two-minute intervals. During the test, subjects will be asked to report the onset of the first symptoms of claudication.
Time frame: Week 1 (baseline)
Diastolic and systolic blood pressure
For blood pressure measurement, an automatic Omron M3 blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan) will be used. The participant should sit in a comfortable chair with lumbar support for at least 5 minutes before the measurement. They will be asked to place both feet flat on the floor, without crossing their legs, and rest the arm with the cuff on a table at chest height, with the palm facing up. Ensuring that the cuff is properly fitted but not too tight and in contact with bare skin, the blood pressure measurement will proceed. During this process, the subject should refrain from speaking to ensure an accurate and reliable reading. The obtained values will be recorded according to standard blood pressure measurement procedures. This protocol aims to ensure accurate and comfortable measurements to obtain reliable and consistent results in blood pressure evaluation.
Time frame: Week 1 (baseline), Weeks 2-4 (right before every intervention session and 24 hours post-intervention)
No study locations are listed for this record.
Start is estimated for Dec 2025; primary completion for Feb 2026, 2 months later.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 2 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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European University Miguel de Cervantes