Effects of Moderate-intensity Interval Aerobic Exercise (MIIAE) on Inflammatory, Immune, Metabolic, Physical Fitness, and Quality of Life Parameters in Breast Cancer Patients Undergoing Radiotherapy.
6 de mayo de 2026 actualizado por: Universidad Francisco de Vitoria
Breast cancer and its treatment with radiotherapy may be associated with systemic inflammatory, hematological, cardiac, body composition, functional and quality-of-life alterations. Exercise has emerged as a non-pharmacological strategy with potential benefits during oncological treatment; however, further evidence is needed regarding the effects of supervised moderate-intensity interval aerobic exercise during radiotherapy.
This randomized controlled trial aims to evaluate the effects of a supervised moderate-intensity interval aerobic exercise programme on systemic inflammatory and immune-derived hematological indices, cardiac biomarkers, body composition, muscle strength, lower-limb power, sleep quality and breast cancer-specific quality of life in women with breast cancer undergoing radiotherapy.
Participants will be allocated to either an experimental group performing supervised moderate-intensity interval aerobic exercise during radiotherapy or to a control group receiving usual care without structured exercise during the study period. Outcomes will be assessed at baseline and after completion of the intervention period.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: África Ruiz
- Número de teléfono: +34 913 24 80 64
- Correo electrónico: africa.ruiz@ufv.es
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Women aged between 20 and 65 years.
- Clinical diagnosis of breast cancer (Stage I-III).
- Patients who have undergone lumpectomy or mastectomy.
- Scheduled to start radiotherapy treatment.
- Sedentary lifestyle according to international physical activity guidelines.
- Ability to understand and follow instructions.
- Ability to provide written informed consent.
Exclusion Criteria:
- Presence of infectious disease.
- Cardiovascular or respiratory disease.
- Metastatic disease.
- Uncontrolled diabetes mellitus.
- Neuropathy.
- Physically active individuals meeting WHO physical activity recommendations.
- Participation in an exercise intervention program within the last 3 months.
- Any condition that, in the opinion of the research team, may compromise safety or participation.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Moderate-Intensity Interval Aerobic Exercise
Participants perform a supervised moderate-intensity interval aerobic exercise programme during the radiotherapy treatment period.
Training is conducted 3 days per week, on alternate days, under the supervision of a physiotherapist experienced in therapeutic exercise in oncology.
Exercise intensity is prescribed individually according to baseline physiological testing, including lactate response, perceived exertion and clinical tolerance.
Participants continue receiving standard oncological care during radiotherapy.
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Structured and supervised aerobic exercise intervention based on moderate-intensity interval training.
The programme includes repeated aerobic exercise bouts interspersed with recovery periods.
Exercise intensity is individually prescribed and adjusted according to baseline physiological assessment, including blood lactate response, perceived exertion and clinical tolerance.
The intervention is delivered during the radiotherapy treatment period as an adjunct to standard oncological care.
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Sin intervención: Usual Care During Radiotherapy
Participants allocated to the control group receive standard oncological care during the radiotherapy treatment period and do not participate in a structured exercise programme during the study period.
Participants are instructed to maintain their usual lifestyle throughout radiotherapy.
After completion of the study, participants in the control group are offered the same supervised moderate-intensity interval aerobic exercise programme delivered to the experimental group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Systemic Immune-Inflammation Index (SII) will be calculated from peripheral blood parameters obtained through standard hematological analysis using an automated analyzer.
The index will be computed using the formula: platelet count × neutrophil count / lymphocyte count.
Blood samples will be collected under standardized conditions after an overnight fast, with participants instructed to avoid vasoactive medication, caffeine, alcohol and tobacco prior to sampling.
Post-intervention samples will be obtained at least 48 hours after the last exercise session to ensure assessment of chronic rather than acute responses.
This composite index will be used to quantify changes in systemic inflammatory and immune status associated with the intervention.
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Baseline (pre-intervention) and immediately after intervention
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Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Neutrophil-to-Lymphocyte Ratio (NLR) will be calculated from absolute neutrophil and lymphocyte counts obtained through peripheral blood analysis using an automated hematology analyzer.
This index will be used as a marker of systemic inflammatory balance.
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Baseline (pre-intervention) and immediately after intervention
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Platelet Count
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Platelet count will be obtained from peripheral blood samples using standard hematological procedures and automated analysis, and will be used as a parameter of systemic inflammatory and hematological status.
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Baseline (pre-intervention) and immediately after intervention
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Neutrophil Count
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Absolute neutrophil count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess innate immune response.
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Baseline (pre-intervention) and immediately after intervention
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Lymphocyte Count
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Absolute lymphocyte count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess adaptive immune status.
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Baseline (pre-intervention) and immediately after intervention
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NT-proBNP
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be quantified in venous blood samples (pg/ml) using standardized laboratory assays according to manufacturer instructions, as a biomarker of cardiac stress and subclinical cardiac involvement.
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Baseline (pre-intervention) and immediately after intervention
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High-Sensitivity Troponin I
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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High-sensitivity troponin I (hs-TnI) will be measured in venous blood samples (ng/L) using validated high-sensitivity assays according to manufacturer protocols, as a biomarker of myocardial injury.
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Baseline (pre-intervention) and immediately after intervention
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Body Weight
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Body weight will be measured in kilograms using calibrated scales under standardized conditions, with participants in light clothing and barefoot.
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Baseline (pre-intervention) and immediately after intervention
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Phase angle
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
|
Phase angle will be assessed using multifrequency octopolar bioelectrical impedance analysis (BIA) under standardized conditions, including fasting state and controlled hydration status, as an indicator of cellular integrity and body cell mass.
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Baseline (pre-intervention) and immediately after intervention
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Fat Mass
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Fat mass will be assessed using bioelectrical impedance analysis (BIA) following standardized pre-measurement conditions, including fasting and abstinence from exercise, caffeine and alcohol.
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Baseline (pre-intervention) and immediately after intervention
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Muscle Mass
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Muscle mass will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions to evaluate skeletal muscle status.
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Baseline (pre-intervention) and immediately after intervention
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Percentage Body Fat
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Percentage body fat will be determined using bioelectrical impedance analysis (BIA).
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Baseline (pre-intervention) and immediately after intervention
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Visceral fat area
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Visceral fat area (VFA) will be estimated using bioelectrical impedance analysis as an indicator of central adiposity and cardiometabolic risk.
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Baseline (pre-intervention) and immediately after intervention
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Relative Lower-Limb Power: Handgrip Strength
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Right and left handgrip strength will be measured (kg) using a calibrated handheld dynamometer.
Participants will perform three maximal voluntary contractions per hand following standardized procedures, with adequate rest between attempts.
The highest reproducible value for each hand will be recorded.
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Baseline (pre-intervention) and immediately after intervention
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Relative Lower-Limb Power (Chair Stand Test)
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Relative lower-limb power will be assessed using the 30-second Chair Stand Test.
Participants will perform as many full stands as possible from a standardized chair (≈43-45 cm height) within 30 seconds, with arms crossed over the chest.
The number of repetitions will be recorded.
A relative lower-limb power index will be derived from repetitions and body mass, expressed in W/kg equivalent units, providing an estimate of lower-limb functional performance normalized by body mass.
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Baseline (pre-intervention) and immediately after intervention
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Breast Cancer-Specific Functional Quality of Life
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Functional quality of life will be assessed using the functional scales of the EORTC QLQ-C30 and QLQ-BR45 questionnaires.
Scores will be linearly transformed to a 0-100 scale, where higher scores indicate better functional status.
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Baseline (pre-intervention) and immediately after intervention
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Breast Cancer-Specific Symptom Burden
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Symptom burden will be assessed using the symptom scales of the EORTC QLQ-C30 and QLQ-BR45 questionnaires.
Scores will be transformed to a 0-100 scale, where higher scores indicate greater symptom severity.
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Baseline (pre-intervention) and immediately after intervention
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Sleep Quality (PSQI)
Periodo de tiempo: Baseline (pre-intervention) and immediately after intervention
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
The global score will be used for analysis, where higher scores indicate poorer sleep quality.
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Baseline (pre-intervention) and immediately after intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EIMICM1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
At this time, it is unclear whether individual participant data (IPD) will be shared.
Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets.
A final decision will be made once data collection and analysis are completed.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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