Clinical trial NCT06491810: Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer
Official title: Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peripheral Arterial Disease
Keywords: Exercise
Oxygen saturation
Intermittent Claudication
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral artery disease

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.


Eligibility criteria: Inclusion Criteria:

1. aged ≥ 50 years;
2. with PAD confirmed by clinical diagnosis and ankle-brachial index (ABI) \< 0.90 in one or both limbs;
3. experiencing symptoms of intermittent claudication (IC) during walking;
4. with a body mass index (BMI) not exceeding 30 kg/m²;
5. with medical clearance to participate in the project;
6. 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.

Primary outcomes:
measure: Calf Muscule Oxygen Saturation (%)
timeFrame: 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.
Secondary outcomes:
measure: Oxyhemoglobin (micromol)
timeFrame: 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.
measure: Deoxyhemoglobin (micromol)
timeFrame: 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.
measure: Total hemoglobin (micromol)
timeFrame: 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.
measure: Subjective perception of exertion (score)
timeFrame: During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.
measure: Pain (score)
timeFrame: During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Jéssika Silva, Ms
role: STUDY_CHAIR
References:
citation: Cavalcante BR, Ritti-Dias RM, Soares AH, Lima AH, Correia MA, De Matos LD, Gobbi F, Leicht AS, Wolosker N, Cucato GG. A Single Bout of Arm-crank Exercise Promotes Positive Emotions and Post-Exercise Hypotension in Patients with Symptomatic Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 Feb;53(2):223-228. doi: 10.1016/j.ejvs.2016.11.021. Epub 2016 Dec 21.