Oxygen Saturation in the Leg Musculature Affected by Peripheral Arterial Disease During Exercise on an Arm Ergometer

NCT06491810 | Completed

• 1 other identifier: EBPAD_StO
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Exercise; Oxygen saturation; Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Calf Muscule Oxygen Saturation (%)

  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.

  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 (5)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

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.

Other: Arm crank exercise

Interventions

Arm crank exercise OTHER

The arm ergometer exercise will be the only intervention implemented during the study.

Arm crank exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with peripheral artery disease

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University Nove de Julho

São Paulo, São Paulo, 01525-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28012910 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jéssika Silva, Ms

  University of Nove de Julho

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 9, 2024
• Study Start: July 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

BR (1)