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Table 1 Study timeline

From: Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial

 

Screening

T0

Basal

T1

6 W

T2

12-W

T3

6 M

T4

9 M

T5

12 M

Primary outcome

  Number of self-reported falls

 

X

X

X

X

X

X

Secondary outcomes

  Risk of falls

  Usual Gait Speed (UGS)

  Time up and Go (TUG)

X

  

X

   

  Short Physical Performance Battery (SPPB)

 

X

X

X

   

  Barthel index (BI)

X

 

X

X

X

X

X

  Frailty Linda Fried criteria

X

  

X

   

  Montreal Cognitive Assessment (MoCA)

 

X

X

X

   

  Garvan fracture risk calculator

 

X

 

X

X

X

X

  Yesavage GDS Scale

 

X

 

X

X

X

X

  UGS with dual tasking

 

X

X

X

   

  Clinical criteria of sarcopenia

 

X

 

X

   

  Maximal isometric force of handgrip, knee extension and hip flexion

 

X

X

X

   

  Fear of falling (STAC)

 

X

 

X

X

X

X

  Quality of life (EQ-5D)

 

X

 

X

X

X

X

  Previous lifestyle

 

X

     

  Trail Making Test (TMT – Part A)

 

X

X

X

   

  1RM (Leg press)

 

X

X

X

   

  Muscular power at 50% 1RM in leg press

 

X

X

X

   

  Polypharmacy

 

X

 

X

X

X

X

  Cumulative Illness Rating Scale for Geriatrics (CIRS-G)

 

X

     

  Mini Nutritional Assessment Test (MNA)

 

X

     

  Acceleration data: gait kinematic parameters (regularity, variability, cadence), Five Times Sit to Stand Test (peak power, impulse) and balance parameters (power spectrum, area)

 

X

X

X

   

  Muscular Echo intensity and thickness (ultrasound)

 

X

 

X

   

  Mortality

 

X

X

X

X

X

X

  Admissions to emergency room and hospitalizations

 

X

X

X

X

X

X

  Institutionalization

 

X

X

X

X

X

X