Facultad de Mecina y Ciencias de la Salud
Badajoz, Spain
Location contact
Berta Caro Puértolas, PhD
PRINCIPAL_INVESTIGATOR
Mª Dolores Apolo Arenas, PhD
PRINCIPAL_INVESTIGATOR
Mª Dolores MD Apolo-Arenas, PhD
CONTACT
NCT Number: NCT06976593
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.
Trial opening soon.
Get Notified30 year–70 year
Female
Observational
Badajoz, Spain
Berta Caro Puértolas, PhD
PRINCIPAL_INVESTIGATOR
Mª Dolores Apolo Arenas, PhD
PRINCIPAL_INVESTIGATOR
Mª Dolores MD Apolo-Arenas, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within a single assessment session (~1 hour)
Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
0-10 points. 0: no perceived effort 10: maximum perceived effort
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Time frame: During and immediately after functional assessment session
Contact information is provided by the study sponsor or research team.
University of Extremadura
Other
Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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