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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 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: Moderate-Intensity Interval Aerobic Exercise
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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Systemic Immune-Inflammation Index (SII)
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Neutrophil-to-Lymphocyte Ratio (NLR)
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Platelet Count
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Neutrophil Count
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Absolute neutrophil count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess innate immune response.
Baseline (pre-intervention) and immediately after intervention
Lymphocyte Count
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Absolute lymphocyte count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess adaptive immune status.
Baseline (pre-intervention) and immediately after intervention
NT-proBNP
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
High-Sensitivity Troponin I
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Body Weight
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Body weight will be measured in kilograms using calibrated scales under standardized conditions, with participants in light clothing and barefoot.
Baseline (pre-intervention) and immediately after intervention
Phase angle
Ramy czasowe: 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.
Baseline (pre-intervention) and immediately after intervention
Fat Mass
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Fat mass will be assessed using bioelectrical impedance analysis (BIA) following standardized pre-measurement conditions, including fasting and abstinence from exercise, caffeine and alcohol.
Baseline (pre-intervention) and immediately after intervention
Muscle Mass
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Muscle mass will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions to evaluate skeletal muscle status.
Baseline (pre-intervention) and immediately after intervention
Percentage Body Fat
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Percentage body fat will be determined using bioelectrical impedance analysis (BIA).
Baseline (pre-intervention) and immediately after intervention
Visceral fat area
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
Visceral fat area (VFA) will be estimated using bioelectrical impedance analysis as an indicator of central adiposity and cardiometabolic risk.
Baseline (pre-intervention) and immediately after intervention
Relative Lower-Limb Power: Handgrip Strength
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Relative Lower-Limb Power (Chair Stand Test)
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Breast Cancer-Specific Functional Quality of Life
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Breast Cancer-Specific Symptom Burden
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention
Sleep Quality (PSQI)
Ramy czasowe: Baseline (pre-intervention) and immediately after intervention
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.
Baseline (pre-intervention) and immediately after intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universidad Francisco de Vitoria

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 września 2026

Ukończenie studiów (Szacowany)

31 grudnia 2026

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EIMICM1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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