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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