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

NCT ID: NCT06491810

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-10-31

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Arm crank exercise

Intervention Type OTHER

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

Interventions

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Arm crank exercise

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Marilia de Almeida Correia

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jéssika Silva, Ms

Role: STUDY_CHAIR

University of Nove de Julho

Locations

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University Nove de Julho

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 28012910 (View on PubMed)

Other Identifiers

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EBPAD_StO

Identifier Type: -

Identifier Source: org_study_id

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