About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recurrence or metastasis
Severe cardiopulmonary or musculoskeletal disease
Neurological or cognitive limitations
Ongoing oncological treatment
Trial population
The study population consists of women aged 30 to 70 years who have completed treatment for breast cancer. Participants are recruited from outpatient oncology clinics and cancer survivor support groups in the region of Extremadura, Spain. All participants are categorized into two groups based on their treatment history: those who received hormonal therapy only and those who received both hormonal therapy and chemotherapy. All subjects must be able to perform physical tests and attend a single evaluation session.
Trial design
Case-crossover
Prospective
Treatments tested in this trial
Functional Exercise Testing and Muscle Oxygen Saturation Measurement
Diagnostic testParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Muscle oxygen saturation (%)
Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)
Secondary outcomes
Distance covered in the 6-Minute Walk Test (meters)
Number of repetitions in the 30-Second Sit-to-Stand Test
Maximal heart rate and recovery rate during treadmill test
Lower limb fatigue and perceived exertion (Borg scale)
0-10 points. 0: no perceived effort 10: maximum perceived effort
Sponsors and contacts
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