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CompletedNCT06491810Updated Apr 13, 2026

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

An observational study in Peripheral Arterial Disease, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by University of Nove de Julho · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
26
Ages
45 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Exercise
  • Oxygen saturation
  • Intermittent Claudication
03

In context

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

This study's enrollment of 26 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with peripheral artery disease

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 (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherArm crank exercise

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

06

What researchers measure

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.

    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.

Secondary outcomes

  1. Oxyhemoglobin (micromol)

    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.

    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.

  2. Deoxyhemoglobin (micromol)

    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.

    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.

  3. Total hemoglobin (micromol)

    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.

    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.

  4. Subjective perception of exertion (score)

    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.

    Time frame: During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.

  5. Pain (score)

    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."

    Time frame: During 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise.

07

Study locations

1 site
  • University Nove de Julho
    São Paulo, São Paulo 01525-000, Brazil
08

References and documents

Publications

  • 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. PubMed 28012910 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06491810
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Marilia de Almeida Correia (PhD, University of Nove de Julho) — Principal investigator
First posted
Jul 9, 2024
Start date
Jul 1, 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Apr 13, 2026

Study contacts

Jéssika Silva, Ms
study chair · University of Nove de Julho

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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