| Study Phase |
Pre-randomization |
Randomization |
| Visit description (FU=follow-up, CO=close-out) |
Screen |
Baseline |
FU |
CO |
| Visit number |
1 |
2 |
3 |
4 |
| Visit week |
-2 |
0 |
8 |
20 |
| Informed consent, review inclusion/exlusion criteria |
x |
|
|
|
| Personal interveiw, medical history, medication use |
x |
|
|
|
| Office blood pressure (sitting + standing), vital signs |
x |
x |
x |
x |
| Physical exam, height/weight, ECG |
x |
|
|
|
| Randomization |
|
x |
|
|
| Waist circumference, 6 minute walk, blood collection |
|
x |
x |
x |
| Accelerometry, assess adverse experiences |
|
x |
x |
x |
| Diet recall, 4 meter walk, grip strength |
|
x |
x |
x |
| Short Phsyical Performance Battery |
|
x |
|
x |
