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. Author manuscript; available in PMC: 2022 May 1.
Published in final edited form as: Contemp Clin Trials. 2021 Feb 22;104:106326. doi: 10.1016/j.cct.2021.106326

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