Table 2.
INVEST in Bone Health Trial Assessment Timeline
INVEST Measurements | SV1 | SV1A | SV2 | SV3 | INT | FV1 | FV2 | INT | FV3 | FV4 |
---|---|---|---|---|---|---|---|---|---|---|
Participant Status | fasted | fasted | fasted | fasted | ||||||
Weeks | −6 to 0 | 1-24 | 22-26 | 25-52 | 50-54 | |||||
Location | WFSM or WFU | Phone | WFU | WFSM | WFSM or WFU | WFU | WFSM | WFSM or WFU | WFU | WFSM |
Questionnaires | ||||||||||
Phone Screener | ||||||||||
Consent/HIP AA | • | |||||||||
Demographics | • | |||||||||
Medical history | • | • | ||||||||
Medications | • | • | • | •• | • | •• | • | •• | ||
Depression (CES-D) | • | • | •• | •• | •• | |||||
Cognitive Assessment (MoCA) | • | • | ||||||||
Pittsburgh Fatigability Scale | •• | •• | •• | |||||||
PROMIS Pain Intensity and | •• | •• | •• | |||||||
Fatigue | ||||||||||
CHAMPS physical activity | • | • | •• | •• | •• | |||||
Adverse Events | • | •• | •• | • | •• | •• | • | •• | ||
Physical Exams and Physical Performance Measures | ||||||||||
Vital signs | • | • | • | • | • | • | ||||
Anthropometrics | • | • | • | |||||||
eSPPB | • | • | • | |||||||
Hand Grip Test | • | • | • | |||||||
RMR | • | • | • | |||||||
Activity Monitor - thigh | • | • | • | |||||||
Activity Monitor - in vest | • | |||||||||
400-meter Walk – fast | • | • | • | |||||||
TUG | • | • | • | |||||||
Biodex | • | • | • | |||||||
Stair climb | • | • | • | |||||||
Musculoskeletal Assessments | ||||||||||
DXA | • | • | • | |||||||
QCT | • | • | • | |||||||
D3Cr Muscle mass | • | • | • | |||||||
Phlebotomy | ||||||||||
CBC | • | |||||||||
Metabolic Panel | • | |||||||||
Vitamin D | • | |||||||||
Plasma/Serum Storage | • | • | • | |||||||
Other | ||||||||||
Run-in instructions | • | • | ||||||||
Participant Satisfaction | •• | •• | ||||||||
Self-Efficacy | •• | •• | •• | |||||||
Adherence monitoring | • | • |
SV=screening visit, INT=intervention, FV=follow up visit, WFSM=Wake Forest School of Medicine, WFU=Wake Forest University, eSPPB=extended short physical performance battery, RMR=resting metabolic rate, TUG=timed up and go, DXA=dual energy x-ray absorptiometry, QCT=computed tomography, D3Cr-Deuterated creatine dilution method for directly measuring muscle mass, CBC=complete blood count. Occurrence of assessment indicated by •, collected via phone indicated by •• Phone screening will be completed prior to SV1