Acute Effects of Exercise in Peripheral Arterial Disease Patients (VESSEL-FIT)

European University Miguel de Cervantes

Status: Not yet enrolling

Conditions: Traditional Strength Exercise; Aerobic Physical Exercise; Circuit Strength Exercise; Control

Treatments: Other: Aerobic exercise; Other: Circuit strength exercise; Other: Traditional strength exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07248137

PI-DOC009- VESSEL-FIT

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older.
• Patients diagnosed with peripheral arterial disease at grade IIa or IIb according to the Leriche-Fontaine classification.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 4 patient groups

Aerobic exercise

Experimental group

Description:

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).

Treatment:

Other: Aerobic exercise

Traditional strength exercise

Experimental group

Description:

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).

Treatment:

Other: Traditional strength exercise

Circuit strength exercise

Experimental group

Description:

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).

Treatment:

Other: Circuit strength exercise

Control

No Intervention group

Description:

Control. No intervention