Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nove de Julho
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Calf Muscule Oxygen Saturation (%)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Arm crank exercise (Other)
Outcomes
Primary Outcomes
Calf Muscule Oxygen Saturation (%)
Time Frame: 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 Outcomes
- 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.)
- 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.)
- 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.)
- Subjective perception of exertion (score)(During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.)
- Pain (score)(During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.)
Investigators
Marilia de Almeida Correia
PhD
University of Nove de Julho