Exercise intervention to Normalize blood pressure and nocturnal Dipping in HyperTensive patients (END-HT): protocol of a randomized controlled trial.

Abstract

BACKGROUND\nLack of decrease (≤ 10%) in systolic blood pressure during sleep, referred to as non-dipping, independently predicts cardiovascular events and mortality. There has been no prospective and adequately powered randomized-controlled trial to determine whether exercise, when compared to standard treatment, can normalize non-dipping (ND) in patients with hypertension. Further, most patients do not sustain an exercise program by 12 months.\n\n\nMETHOD\nA two-arm, assessor-blinded randomized controlled trial, involving 198 hypertensive Chinese patients who have non-dipping will be conducted to evaluate the effectiveness of a combined exercise (aerobic exercise and resistance training) program to normalize non-dipping (ND). The combined exercise program, exercise is medicine (EIM), was developed to maintain exercise habit using a variety of techniques (e.g. 12-week exercise classes, mobile application, wrist trackers, self-scheduling, monitoring, regular feedback and motivational interviewing). Eligible patients will be randomized to EIM plus usual care or to usual care in 1:1 ratio by stratified randomization according to age and sex. The randomization sequence is blinded to the investigators and allocation is disclosed only after valid consent. Ambulatory blood pressure measurements will be performed at baseline, 3-month and 12-month. The primary outcome is proportion of participants with ND at 3-months; secondary outcomes include proportion of participants with ND at 12-months, absolute BP values at 3-month and 12-month. Exercise level will be detected by validated questionnaire and compared between two arms at 3-month and 12-month.\n\n\nIMPLICATION\nThe trial will examine the efficacy of treating non-dipping and hypertension by an exercise program.