Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer
- Conditions
- Peripheral Arterial Disease
- Interventions
- Other: Arm crank exercise
- Registration Number
- NCT06491810
- Lead Sponsor
- University of Nove de Julho
- Brief Summary
Studies with arm ergometer (AE) training have shown benefits in the functional capacity of patients with peripheral arterial disease (PAD) bypassing the main barrier to exercise in these patients, pain during walking exercise. The only study that proposed to investigate the mechanism involved in this adaptation observed that chronically training with EB promoted improvement in the oxygen saturation (StO₂) of the leg muscles during walking. However, how arm exercise could improve leg muscle StO₂ remains unknown.
The goal of this study is to analyze what happens during AE on the tissue oxygen saturation (StO₂) of the leg affected by PAD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 24
- aged ≥ 50 years;
- with PAD confirmed by clinical diagnosis and ankle-brachial index (ABI) < 0.90 in one or both limbs;
- experiencing symptoms of intermittent claudication (IC) during walking;
- with a body mass index (BMI) not exceeding 30 kg/m²;
- with medical clearance to participate in the project;
- presenting calf skinfold thickness less than 20 mm due to interference of adiposity with the light penetration of the NIRS probe and finger oxygen saturation > 95% to ensure that impaired pulmonary gas exchange does not affect the calf oxygen saturation measurements.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm crank exercise Arm crank exercise The exercise session will consist of 15 sets of 2 minutes of exercise in arm ergometer with an intensity equivalent to 13-15 on the Borg's perceived exertion scale.
- Primary Outcome Measures
Name Time Method Calf Muscule Oxygen Saturation (%) Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise. The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
- Secondary Outcome Measures
Name Time Method Oxyhemoglobin (micromol) Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise. The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Total hemoglobin (micromol) Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise. The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Deoxyhemoglobin (micromol) Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise. The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Subjective perception of exertion (score) During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise. Subjective perception of effort will be assessed using the Borg Scale, from 6 to 20, where participants rate their perceived exertion during the exercise session.
Pain (score) During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise. Pain will be assessed using the Visual Analog Scale (VAS), where participants mark their current level of pain on a horizontal line typically 10 centimeters in length. One end represents "no pain," while the other end signifies "worst pain imaginable."
Trial Locations
- Locations (1)
University Nove de Julho
🇧🇷São Paulo, Brazil