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Table 3 Time scheme for study conduction

From: The “Hypertension Approaches in the Elderly: a Lifestyle study” multicenter, randomized trial (HAEL Study): rationale and methodological protocol

  Study period
Enrolment Baseline measures Allocation and run-in* Post-allocation Close out
TIMEPOINT t-1 t0 t1 t2 t3 t4 t5 t5
Timepoint description Interviews Occurs in 2 or 3 evaluation visits Intervention Start Evaluation visit (6th week) Intervention end Final evaluation visit 1 Final evaluation visit 2
ENROLMENT:
 Eligibility screening x        
 Informed consent x        
 Allocation    x      
INTERVENTIONS
 Combined exercise program     x x x   
 Health education program     x x x   
ASSESSMENTS
Primary outcome
 Ambulatory blood pressure   x      x  
Main secondary outcomes
 Office blood pressure   x      x  
 Endothelial function   x    x   x  
 Cardiorespiratory fitness§   x       x
Other outcomes x
 6-min walking test distance   x       x
 SPPB   x       x
 Quality of life questionnaires   x      x  
 Autonomic function   x      x  
Additional measurements
 Anthropometric measurements   x      x  
 Medication adherence scale (MMAS-8 Questionnaires)   x      x  
 Blood variables collection   x      x  
 Self-reported physical activity   x    x   x  
 Grip strength   x    x    x
  1. SPPB Short physical performance battery; MMAS Morisky Medication Adherence Scale. * = run-in period will be no longer than 2 weeks. † = time between t4 and t5 will be no longer than 2 weeks. ‡ = analysis of blood pressure and heart rate variability, exclusive for data collected at the coordinator center; § = cardiorespiratory fitness assessment occurs in a third separate visit at the participating center. Use of the©MMAS is protected by US copyright and registered trademark laws. Permission for use is required. A license agreement is available from Donald E. Morisky, 294 Lindura Court, Las Vegas, NV 89138–4632; dmorisky@gmail.com