Table 3.
Participant flow and timeline from screening to randomization
| Timeline | Action | Participant Data Collected | Purpose | |
|---|---|---|---|---|
| Week 1 | Telephone Screen |
|
To determine initial illegibility | |
| Week 2 | Orientation & CRP Screening |
|
To ensure that the participant understands the expectations of the study and meets inclusion criteria | |
| Week 3–4 | 3 Educational Run-In Sessions |
|
To ensure participant meets inclusion criteria and can visit the intervention site multiple times per week | |
| Week 5 | Baseline Evaluations |
|
Collect baseline data and ensure participant meet remaining study entry criteria | |
| Week 6 | Randomization | |||
| Week 7–23 | Intervention |
Exercise Group:
|
Control Group:
|
Collect intervention data as well as data on potential confounding variables such as health, diet and non-study related activity |
| Week 24 | Follow-Up Evaluations |
|
Collect follow-up data | |
Self Report Data Returned Monthly includes: Medical Symptoms Questionnaire, Medication Inventory and Daily Step Log