Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in peak oxygen consumption (VO2peak) |
Changes in VO2peak assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
3-years recurrence-free survival |
Proportion of patients who survive without relapse (formation of new tumors) for the 3-year period |
Randomization to 3 years after randomization |
|
Secondary |
3-years overall survival |
Proportion of patients who are alive 3 years after randomization |
Randomization to 3 years after randomization |
|
Secondary |
Changes in Aerobic Capacity: Ventilatory threshold |
Changes in ventilatory threshold assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Aerobic Capacity: Peak power output |
Changes in peak power output assessed during an incremental exercise test to volitional exhaustion on a bicycle ergometer |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Muscle strength: Hand grip strength |
Changes in hand grip strength, assessed using a dynamometer |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Muscle strength: Leg press maximal muscle strength |
Changes in leg press one repetition maximum (1RM) |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Functional performance: Habitual gait speed |
Changes in habitual gait speed |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Functional performance: Maximal gait speed |
Changes in maximal gait speed |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Functional performance: Stair climbing performance |
Changes in time required to climb a specific staircase |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Functional performance: 30 seconds Sit-to-stand |
Changes in the number of stands from sitting position that can be performed during 30 seconds |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Body mass |
Changes in body mass |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Total lean mass |
Changes in total lean mass assessed by dual energy x-ray absorptiometry (DXA) |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Total fat mass |
Changes in total fat mass assessed by DXA |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Bone mineral density |
Changes in bone mineral density assessed by DXA |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Waist circumference |
Changes in waist circumference |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Body composition and anthropometrics: Hip circumference |
Changes in Hip circumference |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Systolic Blood pressure |
Changes in resting systolic blood pressure |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Diastolic Blood pressure |
Changes in resting diastolic blood pressure |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Heart rate |
Changes in resting heart rate |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: leukocyte differential counts |
Changes in resting leukocyte differential counts (total and per type [eosinophils, basophils, lymphocytes, monocytes, neutrophils]) |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: C-reactive protein |
Changes in resting C-reactive protein levels in blood |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: Insulin |
Changes in resting insulin blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: Glucose |
Changes in resting glucose blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: Triglycerides |
Changes in resting triglycerides blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: LDL-Cholesterol |
Changes in resting LDL-cholesterol blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Blood biochemistry: HDL-Cholesterol |
Changes in resting HDL-cholesterol blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-6 |
Changes in resting Interleukin-6 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-1 |
Changes in resting Interleukin-1 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-7 |
Changes in resting Interleukin-7 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-8 |
Changes in resting Interleukin-8 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-15 |
Changes in resting Interleukin-15 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-1ß |
Changes in resting Interleukin-1ß blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interleukin-10 |
Changes in resting Interleukin-10 blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Tumor-necrosis-factor alpha (TNFalpha) |
Changes in resting TNFalpha blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Cytokine levels in blood: Interferon gamma (IFN-gamma) |
Changes in resting IFN-gamma blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Immune cells in blood: Natural killer (NK) cells |
Changes in resting NK cells |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Immune cells in blood: CD4 T cells |
Changes in resting CD4 T cells |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Immune cells in blood: CD8 T cells |
Changes in resting CD8 T cells |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Immune cells in blood: B cells |
Changes in resting B cells |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Osteonectin |
Changes in resting osteonectin blood levels |
Baseline, 3-, 6-, 9- and 12 months after exercise training initiation |
|
Secondary |
Changes in Patient-reported symptomatic adverse events |
Patient-reported symptomatic adverse events, assessed using the using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Physical well-being |
Changes in patient-reported physical well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Social well-being |
Changes in patient-reported social well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Emotional well-being |
Changes in patient-reported emotional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-24, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Functional well-being |
Changes in patient-reported functional well-being assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: General |
Changes in patient-reported general health-related qualify of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-108, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Colorectal cancer specific |
Changes in patient-reported colorectal-cancer specific health-related quality of life assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-28, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: total score |
Changes in patient-reported in health-related quality of life (total score) assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-136, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Trial outcome index |
Changes in patient-reported trial outcome index assessed using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) (scale scoring 0-84, the higher the score the better quality of life) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Health-related quality of life: Fatigue |
Changes in patient-reported fatigue assessed using the Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-Fatigue) (scale score: 0-52, the higher the score the less fatigue) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Depression |
Changes in patient-reported depression, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Anxiety |
Changes in patient-reported anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) (scale scoring: 0-21, the higher the score the worse the condition) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Physical activity: Walking |
Changes in patient-reported weekly duration of walking, assessed using the International Physical Activity Questionnaire (IPAQ) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Physical activity: Moderate intensity physical activity |
Changes in patient-reported weekly duration of moderate intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Physical activity: Vigorous intensity physical activity |
Changes in patient-reported weekly duration of vigorous intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Physical activity: Total intensity physical activity |
Changes in patient-reported weekly duration of total intensity physical activity, assessed using the International Physical Activity Questionnaire (IPAQ) (Expressed as metabolic equivalent (MET)-min per week: MET level x minutes of activity x events per week) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Physical activity: sitting time |
Changes in patient-reported weekly sitting time, assessed using the International Physical Activity Questionnaire (IPAQ) |
Baseline, 3-, 6-, 9-, 12-, 24- and 36 months after exercise training initiation |
|
Secondary |
Changes in Circulating tumor DNA (ctDNA) |
Changes in ctDNA in blood |
Baseline, 6-, and 12 months after exercise training initiation |
|
Secondary |
Changes in DNA methylation |
Changes in DNA methylation derived from blood |
Baseline, 6-, and 12 months after exercise training initiation |
|
Secondary |
Changes in treatment tolerance: Relative dose intensity (RDI) of adjuvant chemotherapy |
RDI (%) of adjuvant chemotherapy, calculated as the actual dose intensity / standard dose intensity x 100% |
From date of planned initiation to end of adjuvant chemotherapy |
|
Secondary |
Postoperative hospital admissions |
Incidence of postoperative hospital re-admissions, defined as any non-scheduled = 24 h hospitalization |
From discharge to 12 months after exercise training initiation |
|
Secondary |
Postoperative complications |
Incidence of postoperative complications up to 30 days after surgery (total and by grade and type), assessed using the Clavien-Dindo classification |
From discharge to 30 days after discharge |
|