Exercise Training After Upper Gastrointestinal Cancer Surgery

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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 inc
• Behavioral 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 resi

Primary outcome measures

• Peak oxygen uptake (VO₂peak) [Time frame: Baseline and 8 weeks after the intervention]

Secondary outcome measures (12)

• Handgrip strength [Time frame: Baseline and 8 weeks after the intervention]
• Chair stand test [Time frame: Baseline and 8 weeks after the intervention]
• Short Physical Performance Battery (SPPB) [Time frame: Baseline and 8 weeks after the intervention]
• Skeletal muscle mass [Time frame: Baseline and 8 weeks after the intervention]
• Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form) [Time frame: Baseline and 8 weeks after the intervention]
• Total exercise volume [Time frame: During the 8-week intervention period]
• Exercise adherence [Time frame: During the 8-week intervention period]
• Patient-reported outcomes [Time frame: Baseline and 8 weeks after the intervention]
• Blood biomarkers [Time frame: Baseline and 8 weeks after the intervention]
• Gut microbiome [Time frame: Baseline and 8 weeks after the intervention]
• Urinary urea nitrogen [Time frame: Baseline and 8 weeks after the intervention]
• Adverse events [Time frame: During the 8-week intervention period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 2 centers

• Kansai Medical University — Hirakata
• Kansai Medical University — Hirakata

Identifiers

NCT: NCT07561840 · 2025287

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗