| |
Screening visit
|
Randomization visit
|
Study visit
|
End of treatment
|
Follow-up visit
|
|---|
|
D-7
|
D0
|
W2
|
W4
|
W6
|
W8
|
W10
|
W12
|
W14
|
W16
|
W20
|
M6
|
M8
|
M10
|
M12
|
M14
|
M16
|
M18
|
M20
|
M22
|
M24
|
|---|
|
Informed consent
|
X
| | | | | | | | | | | | | | | | | | | | |
|
Randomization
| |
X
| | | | | | | | | | | | | | | | | | | |
|
Inclusion criteria
|
X
| | | | | | | | | | | | | | | | | | | |
|
Physical activity partner
|
X
| | | | | | | | | | | | | | | | | | | |
|
Physical activity level GPAQ
|
X
| | | | | | | | | | | | | | | | | | | |
|
Demographic and clinical data
|
X
| | | | | | | | | | | | | | | | | | | | |
|
Concomitant treatment
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Pathological data
|
X
| | | | | | | | | | | | | | | | | | | |
|
Clinician visit
|
X
|
X
| |
X
| |
X
| | | |
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
APA professional
| |
X
| | | | | | | |
X
| |
(X)
| | |
(X)
| | |
(X)
| | |
(X)
|
|
Dietitian
| |
X
|
X
|
X
| |
X
| |
X
| |
X
| |
(X)
| | |
(X)
| | |
(X)
| | |
(X)
|
|
Physical exam
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
ECG
|
X
| | | | | | | | | | | | | | | | | | | | |
|
Questionnaires
| |
X
| | | |
X
| | | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
6-minute walking test
| |
X
| | | |
X
| | | |
X
| |
X
| | |
X
| | |
X
| | |
X
|
|
Maximal strength test
| |
X
| | | |
X
| | | |
X
| |
X
| | |
X
| | |
X
| | |
X
|
|
Body composition
| |
X
| | | |
X
| | | |
X
| |
X
| | |
X
| | |
X
| | |
X
|
|
Physical activity level IPAQ
| |
X
| | | |
X
| | | |
X
| |
X
| | |
X
| | |
X
| | |
X
|
|
Biology tests
| | | | | | | | | | | | | | | | | | | | | |
|
Type 1
| |
X
| | | |
X
| | | |
X
| |
X
| | |
X
| | |
X
| | |
X
|
|
Type 2
|
X
| |
X
| |
X
| |
X
| |
X
| |
X
| |
X
|
X
| |
X
|
X
| |
X
|
X
| |
|
Type 3
| | | |
X
| | | |
X
| | | | | | | | | | | | | |
|
Biobank (optional)
| |
X
| | | | | | | | | | | | | | | | | | | |
|
TAP-CT
|
X
| | | |
Xa
| | | |
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
CA-19.9
|
X
| | | |
Xa
| | | |
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Adverse events
| | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
- CA 19–9 carbohydrate antigen 19–9, CRP C-reactive protein, GPAQ Global Physical Activity Questionnaire, HbA1c glycated hemoglobin, HOMA homeostasis model assessment, IGF-1 insulin-like growth factor 1, IPAQ International Physical Activity Questionnaire, TAP-CT thoraco-abdominopelvic computed tomography
- aA 2-week time (+/−) interval is considered as acceptable
- (X): only for patients pursuing the APA program after week 16
- Biology tests - type 1: blood cell count, CRP, fasting glucose, HbA1c, insulin/HOMA, IGF-1, albumin, prealbumin
- Biology tests - type 2: blood cell count, CRP, fasting glucose, albumin, prealbumin
- Biology tests - type 3: blood cell count, CRP, fasting glucose, insulin/HOMA, IGF-1, albumin, prealbumin
