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Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06976593
Enrollment
30
Registered
2025-05-16
Start date
2025-05-05
Completion date
2025-05-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Survivorship, Exercise, Functional Capacity, Hormonal Therapy, Muscle Oxygenation, Near-infrared Spectroscopy, Quality of Life

Brief summary

This cross-sectional observational study aims to assess muscle oxygen saturation (SmO2) in the intercostal, quadriceps, and triceps surae muscles using near-infrared spectroscopy (NIRS) during functional exercise tests in breast cancer survivors. Participants will be grouped based on their previous cancer treatment: hormonal therapy only or hormonal therapy combined with chemotherapy. Functional performance will be evaluated through the 6-Minute Walk Test, 30-Second Sit-to-Stand Test, and a submaximal treadmill test. The study will analyze differences in muscle oxygenation and performance between groups and explore associations with other functional and clinical parameters.

Detailed description

This study focuses on evaluating muscle oxygen saturation and physical performance in women who have survived breast cancer. Cancer treatments such as chemotherapy and hormonal therapy can lead to systemic effects, including muscular deconditioning, fatigue, and reduced cardiorespiratory capacity. Near-infrared spectroscopy (NIRS) offers a non-invasive means of assessing SmO2 in real-time, providing insight into oxygen delivery and utilization during exercise. Participants will undergo three functional tests: the 6-Minute Walk Test, the 30-Second Sit-to-Stand Test, and a submaximal treadmill test. Muscle oxygenation will be measured in three key muscle groups before, during, and after each task. Additional outcomes include functional test performance, respiratory strength, pulmonary function, fatigue perception, and quality of life questionnaires. This study will explore whether prior cancer treatment protocols affect muscle oxygenation and physical function differently, and may inform future rehabilitation strategies tailored to breast cancer survivors.

Interventions

DIAGNOSTIC_TESTFunctional Exercise Testing and Muscle Oxygen Saturation Measurement

Participants will complete three physical performance tests: (1) the 6-Minute Walk Test (6MWT), (2) the 30-Second Sit-to-Stand Test, and (3) a submaximal treadmill test. Muscle oxygen saturation (SmO2) will be continuously monitored during the tests using near-infrared spectroscopy (NIRS) devices placed on the intercostal, quadriceps, and triceps surae muscles. Additional variables such as heart rate, perceived exertion, respiratory pressures, pulmonary function, and fatigue will be assessed during or after the tests.

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Women aged 30 to 70 years * Clinical history of breast cancer treatment (at least 6 months prior) * Completed primary cancer treatment * Ability to perform physical tests * Signed informed consent

Exclusion criteria

* Recurrence or metastasis * Severe cardiopulmonary or musculoskeletal disease * Neurological or cognitive limitations * Ongoing oncological treatment

Design outcomes

Primary

MeasureTime frameDescription
Muscle oxygen saturation (%)Within a single assessment session (~1 hour)Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)

Secondary

MeasureTime frameDescription
Number of repetitions in the 30-Second Sit-to-Stand TestDuring and immediately after functional assessment session
Maximal heart rate and recovery rate during treadmill testDuring and immediately after functional assessment session
Lower limb fatigue and perceived exertion (Borg scale)During and immediately after functional assessment session0-10 points. 0: no perceived effort 10: maximum perceived effort
Maximal inspiratory pressures (Pimax)During and immediately after functional assessment session
Distance covered in the 6-Minute Walk Test (meters)During and immediately after functional assessment session
Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of CancerDuring and immediately after functional assessment session
Maximal expiratory pressures (Pemax)During and immediately after functional assessment session
Quality of life (BR23)During and immediately after functional assessment session
Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6)During and immediately after functional assessment session

Countries

Spain

Contacts

Primary ContactMª Dolores MD Apolo-Arenas, PhD
mdapolo@unex.es924489180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026