Acute Effects of Exercise in Peripheral Arterial Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic exercise, Traditional strength exercise, Circuit strength exercise.
- Who it may be relevant to
- Registry conditions: Aerobic Physical Exercise, Traditional Strength Exercise, Circuit Strength Exercise, Control. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Effects of Different Physical Exercise Conditions in Patients With Peripheral Arterial Disease
Overview
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.
Interventions
- Other 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 continu - 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 rat - 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
Primary outcome measures
- Blood Flow [Time frame: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)]
- Peripheral oxygen saturation [Time frame: Week 1 (baseline), Weeks 2-4 (during each intervention session)]
- Heart rate variability [Time frame: Week 1 (baseline), Weeks 2-4 (during intervention and 24, 48, and 72 hours post-intervention)]
- Proteomics [Time frame: Weeks 2-4 (5 minutes prior to exercise and 5 minutos post-intervention)]
Secondary outcome measures (3)
- Post-exercise oxygen debt [Time frame: Weeks 2-4 (after every intervention session)]
- Perceived exertion [Time frame: Weeks 2-4 (right after every intervention session and 24, 48, and 72 hours post-intervention)]
- Satisfaction with the type of training [Time frame: Weeks 2-4 (right after every intervention session and 24 and 48 post-intervention)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07248137 · PI-DOC009- VESSEL-FIT