Exercise Training After Upper Gastrointestinal Cancer Surgery

NCT07561840 | Not Yet Recruiting

• 1 other identifier: 2025287
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer (Diagnosis); Upper Gastrointestinal Cancer

Keywords

upper gastrointestinal cancers; exercise; high-intensity interval training; randomized controlled trial; exercise oncology

Outcome Measures

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.

  Baseline and 8 weeks after the intervention

Secondary Outcomes (14)

• 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

Study Arms (3)

High-Intensity Interval Training (HIIT)

EXPERIMENTAL

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.

Behavioral: High-Intensity Interval Training (HIIT)

Low-Intensity Continuous Training (LICT)

EXPERIMENTAL

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.

Behavioral: Low-Intensity Continuous Training (LICT)

Usual Care (Control)

NO INTERVENTION

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.

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.

Also known as: HIIT

High-Intensity Interval Training (HIIT)

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.

Also known as: LICT

Low-Intensity Continuous Training (LICT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosed with esophageal or gastric cancer
• Received curative surgery
• ± 2 weeks after surgery
• Ability to provide written informed consent

You may not qualify if:

• Communication difficulties
• Poor general status
• Undergone combined laryngopharyngectomy
• Unsuitable for evaluation or exercise intervention
• Unsuitable for the study as determined by the primary physician

Sponsors & Collaborators

• Kansai Medical University: lead

Study Sites (1)

Kansai Medical University

Hirakata, Osaka, 573-1136, Japan

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Disease; Gastrointestinal Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Takuya Fukushima

  Kansai Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takuya Fukushima

CONTACT

+81-72-856-2115; fukushima.tky@kmu.ac.jp

Jiro Nakano

CONTACT

+81-72-856-2115; nakano.jir@kmu.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)