Exercise Training After Upper Gastrointestinal Cancer Surgery

Sponsor
Kansai Medical University
Study ID
NCT07561840
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-Intensity Interval Training (HIIT) — BEHAVIORAL
    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.
  • Low-Intensity Continuous Training (LICT) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
171 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

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

Central Contacts

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