Table 1.
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) flow diagram for timeline of study visits for the Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy trial.
| Time pointa | Week 0 | Week 1-17 | Week 9 | Week 17 or 18b | Week 17-34 | Week 34c | |||||||
| Enrollment | |||||||||||||
|
|
Eligibility screen | ✓ |
|
|
|
|
|
||||||
|
|
Phone screen | ✓ |
|
|
|
|
|
||||||
|
|
Informed consent | ✓ |
|
|
|
|
|
||||||
|
|
Allocation | ✓ |
|
|
|
|
|
||||||
|
|
Exercise screening | ✓ |
|
|
|
|
|
||||||
| Interventions | |||||||||||||
|
|
HIITd |
|
✓ |
|
|
|
|
||||||
|
|
Attention control |
|
✓ |
|
|
✓ (optional) |
|
||||||
| Assessments | |||||||||||||
|
|
Executive function and memory | ✓ |
|
|
✓ |
|
✓ | ||||||
|
|
MRIe | ✓ |
|
|
✓ |
|
✓ | ||||||
|
|
Blood biomarkers | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Anthropometrics | ✓ |
|
✓ (no DEXAf) | ✓ |
|
✓ | ||||||
|
|
Cardiorespiratory fitness | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Muscle strength | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Physical function | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Psychosocial measures | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Peripheral neuropathy | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Lymphedema assessment | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Shoulder function and range of motion | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Dietary intake | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
ActiGraph | ✓ |
|
✓ | ✓ |
|
✓ | ||||||
|
|
Activity logs |
|
✓ |
|
|
✓ |
|
||||||
aWeek 0: enrollment and baseline assessment; week 1 to 17: intervention period; week 9: midpoint assessment; week 17 or 18: postintervention assessment; week 17 to 34: follow-up period; week 34: follow-up assessment.
bDepends on whether a participant has any exercise sessions to make up.
cOnly for the high-intensity interval training group and the attention control participants who choose to complete the high-intensity interval training program during the follow-up period.
dHIIT: high-intensity interval training.
eMRI: magnetic resonance imaging.
fDEXA: dual-energy x-ray absorptiometry.