Combined Exercise Training vs Health Education for Older Adults with Hypertension: The HAEL Randomized Clinical Trial

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Abstract Importance Hypertension is a prevalent condition among the elderly, necessitating effective lifestyle interventions to reduce ambulatory blood pressure (BP) and improve overall health. Objective To determine whether a pragmatic combined exercise training program is more effective than a health education program in reducing ambulatory BP in older adults with hypertension. Design The “Hypertension Approaches in the Elderly: a Lifestyle study” (HAEL) was a multicenter, single-blinded, randomized clinical trial. Setting Participants were recruited from September 2017 and June 2020 in two centers in Brazil. Participants Individuals aged 60 years or older with a diagnosis of hypertension as assessed by ambulatory BP monitoring or current use of anti-hypertensive drugs were included. Interventions Participants (n=160) were randomized to a supervised, moderate-intensity, training (3 times/week) that involved aerobic and resistance exercises in a pragmatic setting or to a health education program including weekly, 1-hour workshops addressing hypertension management. Main outcomes and measures The primary outcome was the 3-month change in systolic BP assessed by 24-hour ambulatory BP monitoring. Secondary outcomes were diastolic BP, endothelial function, functional capacity, and quality of life. Data analyses were conducted using the intention-to-treat (ITT) and a prespecified per-protocol approach. Results Out of 717 individuals screened, 160 participants (mean [SD] age, 67.4 [5.5]; 104 females [62%]) were randomized. Compared with health education, exercise training did not reduce 24-hour ambulatory systolic BP (129.1 vs 128.9 mmHg; P=0.98) or diastolic BP (74.2 vs 74.4 mmHg; P=0.90), with measures remaining stable from baseline in both groups and no differences across daytime and nighttime timeframes. Compared with the health education program, combined exercise training increased peak oxygen consumption (0.4 ml/kg/min; 95% CI, -0.5 to +1.3) and Short Physical Performance Battery scores (0.7; 95% CI, +0.5 to +1.0). No major differences were detected between interventions for walking distance, quality of life, and endothelial function. The per-protocol analyses, restricted to non-dropout participants with ≥70% adherence to interventions, yielded results consistent with those obtained using the ITT approach. Conclusions and Relevance Among participants in the HAEL study over 3 months, combined exercise training was not superior to a health education program to reduce ambulatory BP. Trial Registration ClinicalTrials.gov Identifier: NCT03264443 . Key Points Question: What is the comparative efficacy of a 12-week combined aerobic and resistance training versus health education in reducing ambulatory blood pressure among older adults with hypertension? Findings: In this two-center randomized clinical trial including 160 older adults with hypertension, there were no significant changes in systolic or diastolic ambulatory blood pressure after 3 months of combined exercise training or health education program. Meaning: A 12-week combined exercise training did not outperform health education in reducing ambulatory blood pressure in older adults with hypertension.

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