Background
Methods/Study design
# | Inclusion criteria |
---|---|
1. | Histologically proven adenocarcinoma of the esophagus or adenocarcinoma of the esophagogastric junction type I-II according to Siewert’s classification, clinical stages IIB-IIIC (T3/T4 and/or N+; M0) according to UICC, 7th edition |
2. | Male |
3. | Age between 18 and 75 years |
4. | Resectable stage according to discussion in the local multidisciplinary tumor board (MDT) of the participating centers and patient medically fit for multimodality therapy (ECOG performance status at least 1 or better, no severe impairment of cardiac, renal, hepatic, endocrine, bone marrow and cerebral functions) |
5. | Planned abdomino-thoracic esophagectomy with gastric pull-up and intrathoracic or cervical anastomosis |
6. |
# | Exclusion criteria |
---|---|
1. | Presence of a second malignant tumor (unless curatively treated >5 years ago) |
2. | Chemotherapy or radiochemotherapy in patient’s history |
3. | Orthopedic, rheumatologic, cardiovascular or neurologic (epilepsy, stroke, Parkinson’s disease, muscle wasting diseases such as amyotrophic lateral sclerosis or multiple sclerosis) contraindications for the exercise program |
4. | Inability to use the internet or no internet access |
5. | Inability to communicate in German |
6. | Each active disease, which hinders completion of the study |
7. | Active alcoholism or illegal drug consumption within the last six months before study entry |
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Change in VO2peak at 12 weeks after surgery
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Change in Forced Expiratory Volume in 1 s (FEV1) directly prior to surgery and at 12 weeks after surgery
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Change in Forced Vital Capacity (FVC) directly prior to surgery and at 12 weeks after surgery
Sample-size calculation and statistical analyzes
Intervention
Stage | Speed (kilometers/hour) | Angle of inclination (degree) | Duration (minutes) |
---|---|---|---|
1 | 3 | 1.5 | 3 |
2 | 3.7 | 3.0 | 3 |
3 | 4.4 | 4.9 | 3 |
4 | 5.1 | 6.3 | 3 |
5 | 5.8 | 7.4 | 3 |
6 | 6.5 | 8.2 | 3 |
7 | 6.5 | 9.8 | 3 |
8 | 6.5 | 11.4 | 3 |
9 | 6.5 | 13.0 | 3 |
10 | 6.5 | 14.6 | 3 |
11 | 6.5 | 16.2 | 3 |
12 | 6.5 | 17.8 | 3 |
13 | 6.5 | 19.4 | 3 |
14 | 6.5 | 21.0 | 3 |
Absolute indication | Relative indication |
---|---|
ECG ST-segment depression ≥3 mm | Hypertensive dysregulation (RRsyst 230–260 mmHg, RRdiast ≥ 115 mmHg) |
ECG ST-segment elevation ≥1 mm | Drop in blood pressure > 10 mmHg (compared to baseline blood pressure) without signs of myocardial ischemia (no angina pectoris, no ECG ST-segment depression) |
Drop in blood pressure > 10 mmHg (compared to baseline blood pressure) with signs of myocardial ischemia (angina pectoris, ECG ST-segment depression) | Polymorphic extrasystols, duplets (2 consecutive ventricular extrasystols), salves (≥ 3 consecutive ventricular extrasystols) |
Moderate-severe angina pectoris-symptoms | Supraventricular tachycardias |
Severe dyspnea | Bradyarrhythmias |
Clinical signs of less perfusion (cyanosis) | Line faults |
Persistent (duration >30 s) ventricular tachycardias | Presence of line faults (high AV-blockage, branch block) |
Exhaustion of the patient | reinforced angina pectoris symptoms |
Technical problems (defect ECG-registration, monitor failure) |