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.
2026年5月6日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：África Ruiz
- 電話番号：+34 913 24 80 64
- メール：africa.ruiz@ufv.es
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Systemic Immune-Inflammation Index (SII)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (pre-intervention) and immediately after intervention
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EIMICM1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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.
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