Exercise and Cardiorespiratory Fitness Improvement Through Supervised Training in Upper Gastrointestinal Cancer Surgery Patients (EXCITING-UGI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kansai Medical University
- Enrollment
- 171
- Locations
- 2
- Primary Endpoint
- Peak oxygen uptake (VO₂peak)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: High-Intensity Interval Training (HIIT) (Behavioral)
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.
Intervention: Low-Intensity Continuous Training (LICT) (Behavioral)
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.
Outcomes
Primary Outcomes
Peak oxygen uptake (VO₂peak)
Time Frame: 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.
Secondary Outcomes
- Handgrip strength(Baseline and 8 weeks after the intervention)
- Chair stand test(Baseline and 8 weeks after the intervention)
- Short Physical Performance Battery (SPPB)(Baseline and 8 weeks after the intervention)
- Skeletal muscle mass(Baseline and 8 weeks after the intervention)
- Physical activity (IPAQ-SF)(Baseline and 8 weeks after the intervention)
- Total exercise volume(During the 8-week intervention period)
- Exercise adherence(During the 8-week intervention period)
- Patient-reported outcomes(Baseline and 8 weeks after the intervention)
- Blood biomarkers(Baseline and 8 weeks after the intervention)
- Gut microbiome(Baseline and 8 weeks after the intervention)
- Urinary urea nitrogen(Baseline and 8 weeks after the intervention)
- Adverse events(During the 8-week intervention period)
- Pneumonia(During the 8-week intervention period)
- Readmission(During the 8-week intervention period)
- Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form)(Baseline and 8 weeks after the intervention)
- Handgrip strength(Baseline, 4 weeks, and 8 weeks after the intervention)
- Chair stand test(Baseline, 4 weeks, and 8 weeks after the intervention)
- Urinary urea nitrogen(Baseline, 4 weeks, and 8 weeks after the intervention)
- Short Physical Performance Battery (SPPB)(Baseline, 4 weeks, and 8 weeks after the intervention)
- Skeletal muscle mass(Baseline, 4 weeks, and 8 weeks after the intervention)
- Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form)(Baseline, 4 weeks, and 8 weeks after the intervention)
- Patient-reported outcomes(Baseline, 4 weeks, and 8 weeks after the intervention)
- Blood biomarkers(Baseline, 4 weeks, and 8 weeks after the intervention)
Investigators
Takuya Fukushima
Assistant Professor
Kansai Medical University