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Table 3 Timing of study assessments

From: Discontinuously supervised aerobic training vs. physical activity promotion in the self-management of type 2 diabetes in older Italian patients: design and methods of the ‘TRIPL-A’ randomized controlled trial

  Screening Visit 1 baseline Visit 2 follow-up 1 Visit 3 follow-up 2 Visit 4 follow-up 3
Weeks from randomization -2 0 24 48 76
Visit window in weeks +  2 +/− 2 +/− 2 +/−  2
Informed consent X     
Demographics X     
Inclusion/exclusion criteria X X    
Anthropometric measures   X X X X
Clinical variables   X X X X
Randomization   X    
Lifestyle counseling   X    
Lifestyle informative material   X    
WBA training (only for intervention group)   X    
Blood pressure   X X X X
Registration of laboratory assays   X X X X
IPAQ (short form)   X X X X
EQ-5D-5L   X    X
PSQI   X    X
Healthcare resource consumption   X X X X
 Adverse events including hypoglycemia   X X X X
 New diagnoses   X X X X
Intervention compliance check    X X X
Trial completion      X
  1. Notes: LDCW long distance corridor walk, IPAQ International Physical Activity Questionnaire, EQ-5D-5L Euro Quality of Life 5 Dimensional questionnaire, PSQI Pittsburgh Sleep Quality Index