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 |