Exercise Training After Upper Gastrointestinal Cancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKansai Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosed with esophageal or gastric cancer
Received curative surgery
6 ± 2 weeks after surgery
Disqualifiers
Communication difficulties
Poor general status
Undergone combined laryngopharyngectomy
Unsuitable for evaluation or exercise intervention
Trial design
Design model
Parallel
Treatments tested in this trial
High-Intensity Interval Training (HIIT)
BehavioralSupervised 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.
Low-Intensity Continuous Training (LICT)
BehavioralSupervised 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.
Treatment groups
171 Participants
are divided into 3 treatment groupsGroup A: High-Intensity Interval Training (HIIT)Experimental treatment 1 intervention
Group B: Low-Intensity Continuous Training (LICT)Experimental treatment 1 intervention
Group C: Usual Care (Control)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Peak oxygen uptake (VO₂peak)
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.
Time frame
Baseline and 8 weeks after the interventionSecondary outcomes
1
Handgrip strength
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.
Time frame
Baseline, 4 weeks, and 8 weeks after the intervention2
Chair stand test
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.
Time frame
Baseline, 4 weeks, and 8 weeks after the intervention3
Short Physical Performance Battery (SPPB)
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).
Time frame
Baseline, 4 weeks, and 8 weeks after the intervention4
Skeletal muscle mass
Skeletal muscle mass will be measured using a segmental multi-frequency bioelectrical impedance analyzer (InBody770, InBody Japan Inc., Tokyo, Japan).
Time frame
Baseline, 4 weeks, and 8 weeks after the interventionSponsors and contacts
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Source ClinicalTrials.gov