Esophageal CancerNCT07561840
Exercise Training After Upper Gastrointestinal Cancer Surgery
A study testing High-Intensity Interval Training (HIIT) and Low-Intensity Continuous Training (LICT) in people with Esophageal Cancer and Gastric Cancer (Diagnosis), run by Kansai Medical University at 2 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer (Diagnosis), Upper Gastrointestinal Cancer
- What is being tested?
- High-Intensity Interval Training (HIIT) and Low-Intensity Continuous Training (LICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesJapan
- Study dates
- 15 May 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosed with esophageal or gastric cancer
- Received curative surgery
- 6 ± 2 weeks after surgery
- Ability to provide written informed consent
Who cannot join
- Communication difficulties
- Poor general status
- Undergone combined laryngopharyngectomy
- Unsuitable for evaluation or exercise intervention
- Unsuitable for the study as determined by the primary physician
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Not yet recruiting
Kansai Medical University
Hirakata, Osaka, 573-1136
Takuya Fukushima, +81-72-856-2115, fukushima.tky@kmu.ac.jp
Jiro Nakano, +81-72-856-2115, nakano.jir@kmu.ac.jp
- Recruiting
Kansai Medical University
Hirakata, Osaka, 573-1136
Takuya Fukushima, +81-72-856-2115, fukushima.tky@kmu.ac.jp
Jiro Nakano, +81-72-856-2115, nakano.jir@kmu.ac.jp
About this study
Official title: Exercise and Cardiorespiratory Fitness Improvement Through Supervised Training in Upper Gastrointestinal Cancer Surgery Patients (EXCITING-UGI)
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.
Read the 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.
- Being tested
- High-Intensity Interval Training (HIIT), Low-Intensity Continuous Training (LICT)
- Keywords
- upper gastrointestinal cancers, exercise, high-intensity interval training, randomized controlled trial, exercise oncology
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Disease, Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training (HIIT)Behavioural
Also called HIIT
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)Behavioural
Also called LICT
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks after the intervention
Secondary outcomes (14)
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.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
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.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
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).
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Skeletal muscle mass
Skeletal muscle mass will be measured using a segmental multi-frequency bioelectrical impedance analyzer (InBody770, InBody Japan Inc., Tokyo, Japan).
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form)
Physical activity will be assessed using the Japanese version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The IPAQ-SF provides an estimate of total physical activity expressed in metabolic equivalent task minutes per week (MET-min/week), calculated based on walking, moderate, and vigorous physical activities. The total score ranges from 0 to theoretically unlimited values, with higher scores indicating greater levels of physical activity.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Total exercise volume
Total exercise volume will be calculated as the cumulative prescribed aerobic and resistance exercise over the 8-week intervention period. Aerobic exercise volume will be based on prescribed duration and intensity (HIIT or LICT protocols). Resistance training volume will be calculated by taking into account both the number of sets and repetitions performed across all prescribed exercises during the intervention period.
Measured: During the 8-week intervention period
Exercise adherence
Exercise adherence will be defined as the proportion of completed supervised exercise sessions and compliance with the prescribed exercise protocol, expressed as a percentage.
Measured: During the 8-week intervention period
Patient-reported outcomes
Health-related quality of life and symptoms will be assessed using the EORTC QLQ-C30. Scores for functional scales, symptom scales, and global health status will be linearly transformed to a 0-100 scale.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Blood biomarkers
Serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), irisin, SPARC, and adrenaline will be measured.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Gut microbiome
Gut microbiome composition will be analyzed using 16S rRNA sequencing of stool samples to assess alpha diversity, beta diversity, and taxonomic composition.
Measured: Baseline and 8 weeks after the intervention
Urinary urea nitrogen
Urinary urea nitrogen (UUN) as an indicator of protein metabolism and nutritional status.
Measured: Baseline, 4 weeks, and 8 weeks after the intervention
Adverse events
All adverse events will be systematically recorded throughout the study period.
Measured: During the 8-week intervention period
Pneumonia
Pneumonia will be defined as new or progressive infiltrates on chest radiographs or CT scans, as well as meeting at least two of the following three criteria: body temperature greater than 38°C, leukopenia or leukocytosis (white blood cell count less than 4 × 10⁹/L or greater than 10 × 10⁹/L), and purulent sputum.
Measured: During the 8-week intervention period
Readmission
Unplanned hospital readmission will be defined as any admission occurring after discharge and within the study period, extracted from medical records.
Measured: During the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 May 2026
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansai Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takuya Fukushima, Kansai Medical University
- Investigators
- Takuya Fukushima, Principal investigator, Kansai Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561840
- Sponsor's protocol ID
- 2025287
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations and the sensitive nature of clinical and biological data collected from patients with cancer.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Cardiorespiratory Fitness Improvement Through Supervised Training in Upper Gastrointestinal Cancer Surgery Patients (EXCITING-UGI)
- ClinicalTrials.gov ID
- NCT07561840
- Acronym / sponsor ID
- 2025287
- Keywords
- upper gastrointestinal cancers, exercise, high-intensity interval training, randomized controlled trial, exercise oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Kansai Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Behavioral: 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. |
| Low-Intensity Continuous Training (LICT) | Experimental | 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosed with esophageal or gastric cancer
- Received curative surgery
- 6 ± 2 weeks after surgery
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Communication difficulties
- Poor general status
- Undergone combined laryngopharyngectomy
- Unsuitable for evaluation or exercise intervention
- Unsuitable for the study as determined by the primary physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Interval Training (HIIT)Also: HIITSupervised 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. | Behavioural | High-Intensity Interval Training (HIIT) |
| Low-Intensity Continuous Training (LICT)Also: LICTSupervised 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. | Behavioural | Low-Intensity Continuous Training (LICT) |
Primary outcome
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.
14 secondary outcomes
Handgrip strength
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Chair stand test
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Skeletal muscle mass
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Physical activity (Japanese version of the International Physical Activity Questionnaire-Short Form)
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Total exercise volume
Time frame: During the 8-week intervention period
Exercise adherence
Time frame: During the 8-week intervention period
Patient-reported outcomes
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Blood biomarkers
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Gut microbiome
Time frame: Baseline and 8 weeks after the intervention
Urinary urea nitrogen
Time frame: Baseline, 4 weeks, and 8 weeks after the intervention
Adverse events
Time frame: During the 8-week intervention period
Pneumonia
Time frame: During the 8-week intervention period
Readmission
Time frame: During the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations and the sensitive nature of clinical and biological data collected from patients with cancer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Takuya Fukushima principal investigator
Kansai Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training (HIIT) and Low-Intensity Continuous Training (LICT) in people with Esophageal Cancer and Gastric Cancer (Diagnosis), run by Kansai Medical University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takuya Fukushima (+81-72-856-2115, fukushima.tky@kmu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO₂peak) (time frame: Baseline and 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.