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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Age ≥ 18 years

• Diagnosed with esophageal or gastric cancer

• Received curative surgery

• 6 ± 2 weeks after surgery

• Ability to provide written informed consent

Locations

Other Locations

Japan

Kansai Medical University

NOT_YET_RECRUITING

Hirakata

Kansai Medical University

RECRUITING

Hirakata

Contact Information

Primary

Takuya Fukushima

fukushima.tky@kmu.ac.jp

+81-72-856-2115

Backup

Jiro Nakano

nakano.jir@kmu.ac.jp

+81-72-856-2115

Time Frame

Start Date: 2026-05-15

Estimated Completion Date: 2029-11

Participants

Target number of participants: 171

Treatments

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.

Related Therapeutic Areas

Esophageal Cancer

Stomach Cancer

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