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Table 4 Variables assessed at specific times (S: screening, M: month)

From: Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial)

Variables

Measures

S

M0

M3

M6

M9

M12

Primary outcome

      

Global cognition

ADAS-Cog

 

x

x

x

x

x

Secondary outcome

      

Brain volumes

       

Hippocampal volume

MRI

 

x

 

x

 

x

Brain volume

MRI

 

x

 

x

 

x

Ventricle volume

MRI

 

x

 

x

 

x

Other outcomes

      

Discreet cognitive domains

      

Attention

Digit Span (Wechsler)

 

x

x

x

x

x

Processing speed

Digit Symbol (Wechsler)

 

x

x

x

x

x

TMT Part A

Executive function

TMT Part B

 

x

x

x

x

x

EXIT-25

BDS Executive Clock Drawing test

Memory

Logical Memory Story A and B

 

x

x

x

x

x

Immediate Recall

Delayed Recall

Language

Verbal Fluency

 

x

x

x

x

x

Animal

Vegetable

Naming

Boston Naming Test

Exercise adherence

Percent

Every exercise session

Aerobic fitness

Symptom-limited peak cycle-ergometer test,

x

 

x

x

x

x

Shuttle-walk test, 6-minute walk test

 

x

x

x

x

x

Physical function

SPPB, DAD

 

x

x

x

x

x

BPSD

NPI-Q, AMS, CSDD

 

x

x

x

x

x

Medical changes

Medical diagnoses, falls, medications, and health care service use

Monthly

Covariates

      

AD stage

CDR, MMSE

x

     

Demographics

Age, education, gender, race

x

     

Premorbid intellect

WTAR

 

x

    

Unsupervised physical activity

PASE, actigraph

Monthly

  1. Abbreviations: AD Alzheimer’s disease, ADAS-Cog Alzheimer’s Disease Assessment Scale-Cognition, AMS Alzheimer’s Mood Scale, BDS Behavioral Dyscontrol Scale, BPSD behavioral and psychological symptoms of dementia, CDR Clinical Dementia Rating, CSDD Cornell Scale for Depression in Dementia, DAD Disability in Alzheimer’s Disease scale, EXIT-25 Executive Interview-25, MRI magnetic resonance imaging, MMSE Mini-Mental State Examination, NPI-Q Neuropsychiatric Inventory-Caregiver, PASE Physical Activity Scale for the Elderly, SPPB Short Physical Performance Battery, TMT Trail Making Test, WTAR Wechsler Test of Adult Reading.