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Exercise Training After Upper Gastrointestinal Cancer Surgery

15. května 2026 aktualizováno: Takuya Fukushima, Kansai Medical University

Exercise and Cardiorespiratory Fitness Improvement Through Supervised Training in Upper Gastrointestinal Cancer Surgery Patients (EXCITING-UGI)

This randomized controlled trial aims to determine the optimal exercise intensity for improving postoperative recovery in patients with upper gastrointestinal cancer. Participants who have undergone curative surgery will be randomly assigned to high-intensity interval training (HIIT), low-intensity continuous training (LICT), or usual care. The exercise interventions will be performed under supervision three times per week for eight weeks. The primary outcome is peak oxygen uptake (VO₂peak), assessed using cardiopulmonary exercise testing. Secondary outcomes include physical function, body composition, patient-reported outcomes, and biological and mechanistic markers such as inflammatory biomarkers, muscle-related factors, and gut microbiota. This study will also explore potential mechanisms underlying exercise-induced adaptations and their association with clinical outcomes.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This study is a single-center, three-arm randomized controlled trial designed to evaluate the effects of exercise intensity on postoperative recovery in patients with upper gastrointestinal cancer. Patients who have undergone curative surgery for esophageal or gastric cancer will be enrolled 6 ± 2 weeks after surgery and randomly assigned to high-intensity interval training (HIIT), low-intensity continuous training (LICT), or usual care. The exercise intervention consists of supervised aerobic and resistance training performed three times per week for eight weeks. HIIT involves repeated high-intensity intervals interspersed with recovery periods, whereas LICT consists of continuous low-intensity aerobic exercise. The primary outcome is the change in peak oxygen uptake (VO₂peak) from baseline to 8 weeks, assessed using cardiopulmonary exercise testing. Secondary outcomes include measures of physical function, skeletal muscle mass, physical activity, quality of life, and biological and mechanistic outcomes such as inflammatory biomarkers, muscle-related factors, and gut microbiome composition. This study aims to clarify the dose-response relationship of exercise intensity and to explore the physiological mechanisms underlying exercise-induced adaptations in the early postoperative phase.

Typ studie

Intervenční

Zápis (Odhadovaný)

171

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Japonsko
    • Osaka
      • Hirakata, Osaka, Japonsko, 573-1136
        • Zatím nenabíráme
        • Kansai Medical University
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Takuya Fukushima
      • Hirakata, Osaka, Japonsko, 573-1136

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed with esophageal or gastric cancer
  • Received curative surgery
  • 6 ± 2 weeks after surgery
  • Ability to provide written informed consent

Exclusion Criteria:

  • Communication difficulties
  • Poor general status
  • Undergone combined laryngopharyngectomy
  • Unsuitable for evaluation or exercise intervention
  • Unsuitable for the study as determined by the primary physician

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: High-Intensity Interval Training (HIIT)
Participants will perform supervised aerobic high-intensity interval training combined with resistance training. Aerobic training is performed on a cycle ergometer and consists of four sets of 4-minute work intervals at 80-95% of VO₂peak, interspersed with 3-minute recovery intervals at 60% of VO₂peak. Each session includes a 3-minute warm-up and a 3-minute cool-down, for a total duration of 34 minutes per session. Exercise is performed three times per week for eight weeks. Resistance training includes chest press, leg extension, leg press, and abdominal exercises using pneumatic resistance machines (HUR, Finland), consisting of two sets of 20-25 repetitions at approximately 20RM. Nutritional counseling is provided by a registered dietitian once every four weeks for a total of two sessions during the intervention period.
Behaviorální: High-Intensity Interval Training (HIIT)
Supervised aerobic high-intensity interval training combined with resistance training and nutritional counseling. Aerobic training is performed on a cycle ergometer and consists of four sets of 4-minute high-intensity intervals at 80-95% of VO₂peak, interspersed with 3-minute recovery periods at 60% of VO₂peak. Each session includes a 3-minute warm-up and a 3-minute cool-down, with a total duration of 34 minutes. Training is performed three times per week for eight weeks. Resistance training includes chest press, leg extension, leg press, and abdominal exercises using pneumatic resistance machines, consisting of two sets of 20-25 repetitions at approximately 20RM. Nutritional counseling is provided by a registered dietitian once every four weeks for a total of two sessions during the intervention period.
Ostatní jména:
  • HIIT
Experimentální: Low-Intensity Continuous Training (LICT)
Participants will perform supervised low-intensity continuous training combined with resistance training and nutritional counseling. Aerobic training is performed on a cycle ergometer at 37-45% of VO₂peak for 28 minutes per session, with a 3-minute warm-up and a 3-minute cool-down, for a total duration of 34 minutes. Exercise is performed three times per week for eight weeks. Resistance training includes chest press, leg extension, leg press, and abdominal exercises using pneumatic resistance machines (HUR, Finland), consisting of two sets of 20-25 repetitions at approximately 20RM. Nutritional counseling is provided by a registered dietitian once every four weeks for a total of two sessions during the intervention period.
Behaviorální: Low-Intensity Continuous Training (LICT)
Supervised low-intensity continuous training combined with resistance training and nutritional counseling. Aerobic training is performed on a cycle ergometer at 37-45% of VO₂peak for 28 minutes per session, with a 3-minute warm-up and a 3-minute cool-down, for a total duration of 34 minutes. Training is performed three times per week for eight weeks. Resistance training is identical to the HIIT group and includes chest press, leg extension, leg press, and abdominal exercises using pneumatic resistance machines, consisting of two sets of 20-25 repetitions at approximately 20RM. Nutritional counseling is provided by a registered dietitian once every four weeks for a total of two sessions during the intervention period.
Ostatní jména:
  • LICT
Žádný zásah: Usual Care (Control)
Participants will receive usual postoperative care without structured exercise intervention. Nutritional counseling is provided by a registered dietitian once every four weeks for a total of two sessions during the study period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Peak oxygen uptake (VO₂peak)
Časové okno: Baseline and 8 weeks after the intervention
Cardiorespiratory fitness will be assessed using symptom-limited cardiopulmonary exercise testing (CPET) on a cycle ergometer under medical supervision with continuous breath-by-breath gas analysis. After a 4-minute unloaded warm-up, workload is increased by 10-20 W/min depending on patient condition, with participants cycling at 50 rpm until volitional exhaustion. The test is terminated when cadence falls below 40 rpm, at physician discretion, or at patient exhaustion, followed by a 2-minute cool-down at 20 W. Continuous 12-lead ECG, blood pressure, and oxygen saturation are monitored during testing. VO₂peak is defined as the highest 30-second averaged oxygen uptake immediately prior to exhaustion. Peak workload, peak heart rate, and oxygen uptake at ventilatory threshold are also recorded.
Baseline and 8 weeks after the intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Handgrip strength
Časové okno: Baseline and 8 weeks after the intervention
Handgrip strength will be measured using a standard adjustable-handle dynamometer (InGrip, InBody Japan Inc., Tokyo, Japan). Measurements will be performed in a standing position with arms at the side. Two maximal voluntary efforts will be recorded for each hand, and the highest value will be used (kg) as the outcome measure.
Baseline and 8 weeks after the intervention
Chair stand test
Časové okno: Baseline and 8 weeks after the intervention
Lower-limb muscle strength will be assessed using the 30-second chair stand test (CS-30). Participants will perform as many sit-to-stand repetitions as possible within 30 seconds without using their hands from a standard chair (approximately 43 cm seat height). The total number of completed stands will be recorded. Extended versions (CS-60 and CS-90) will be derived as endurance indicators.
Baseline and 8 weeks after the intervention
Short Physical Performance Battery (SPPB)
Časové okno: Baseline and 8 weeks after the intervention
Physical performance will be assessed using the SPPB, consisting of standing balance, gait speed, and chair stand tests. Each component is scored and summed to produce a total score ranging from 0 (worst performance) to 12 (best performance).
Baseline and 8 weeks after the intervention
Skeletal muscle mass
Časové okno: Baseline and 8 weeks after the intervention
Skeletal muscle mass will be measured using a segmental multi-frequency bioelectrical impedance analyzer (InBody770, InBody Japan Inc., Tokyo, Japan).
Baseline and 8 weeks after the intervention
Total exercise volume
Časové okno: During the 8-week intervention period
Total exercise volume will be calculated as the cumulative prescribed aerobic and resistance exercise over the 8-week intervention period. Aerobic exercise volume will be based on prescribed duration and intensity (HIIT or LICT protocols). Resistance training volume will be calculated by taking into account both the number of sets and repetitions performed across all prescribed exercises during the intervention period.
During the 8-week intervention period
Exercise adherence
Časové okno: During the 8-week intervention period
Exercise adherence will be defined as the proportion of completed supervised exercise sessions and compliance with the prescribed exercise protocol, expressed as a percentage.
During the 8-week intervention period
Patient-reported outcomes
Časové okno: Baseline and 8 weeks after the intervention
Health-related quality of life and symptoms will be assessed using the EORTC QLQ-C30. Scores for functional scales, symptom scales, and global health status will be linearly transformed to a 0-100 scale.
Baseline and 8 weeks after the intervention
Blood biomarkers
Časové okno: Baseline and 8 weeks after the intervention
Serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), irisin, SPARC, and adrenaline will be measured.
Baseline and 8 weeks after the intervention
Gut microbiome
Časové okno: Baseline and 8 weeks after the intervention
Gut microbiome composition will be analyzed using 16S rRNA sequencing of stool samples to assess alpha diversity, beta diversity, and taxonomic composition.
Baseline and 8 weeks after the intervention
Urinary urea nitrogen
Časové okno: Baseline and 8 weeks after the intervention
Urinary urea nitrogen (UUN) as an indicator of protein metabolism and nutritional status.
Baseline and 8 weeks after the intervention
Adverse events
Časové okno: During the 8-week intervention period
All adverse events will be systematically recorded throughout the study period.
During the 8-week intervention period
Pneumonia
Časové okno: During the 8-week intervention period
Pneumonia will be defined as new or progressive infiltrates on chest radiographs or CT scans, as well as meeting at least two of the following three criteria: body temperature greater than 38°C, leukopenia or leukocytosis (white blood cell count less than 4 × 10⁹/L or greater than 10 × 10⁹/L), and purulent sputum.
During the 8-week intervention period
Readmission
Časové okno: During the 8-week intervention period
Unplanned hospital readmission will be defined as any admission occurring after discharge and within the study period, extracted from medical records.
During the 8-week intervention period
Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form)
Časové okno: Baseline and 8 weeks after the intervention
Physical activity will be assessed using the Japanese version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF provides an estimate of total physical activity expressed in metabolic equivalent task minutes per week (MET-min/week), calculated based on walking, moderate, and vigorous physical activities. The total score ranges from 0 to theoretically unlimited values, with higher scores indicating greater levels of physical activity.
Baseline and 8 weeks after the intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Kansai Medical University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Takuya Fukushima, Kansai Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. května 2026

Primární dokončení (Odhadovaný)

1. listopadu 2029

Dokončení studie (Odhadovaný)

1. listopadu 2029

Termíny zápisu do studia

První předloženo

24. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

24. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared due to ethical considerations and the sensitive nature of clinical and biological data collected from patients with cancer.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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