Postural reprogramming insoles for blood pressure fall and posture misalignment in hypertensive individuals: randomized clinical trial

Abstract

OBJECTIVE: To test the hypothesis that Postural Reprogramming Insoles (PRI)  improves posture and the effect of PRI on average and peaks of blood pressure (BP) in hypertensive individuals. DESIGN: RCT, registered at the Clinical Trials (NCT02401516), with 24 hypertensive individuals. SETTING: All patients underwent Ambulatory Blood Pressure Monitoring (ABPM) and posture assessment (PAS/SAPO software) at the beginning and the end of six weeks. INTERVENTION: intervention group (IG) used PRI and control group (CG) SHAM. MAIN OUTCOME MEASURES: BP averages. SECONDARY OUTCOMES: BP peaks, during awake and asleep periods. Improvement of posture was determined when the angle values assessed decreased or reached zero (perfect alignment). To compare BP, paired, and unpaired Student's t-tests were used, significance level of 5%. Effect size (ES) was assessed with Cohen's D. For posture assessment, Wilcoxon and Mann-Whitney were applied to analysis. Categorical variables, through Chi-square test. RESULTS: Baseline variables did not differ between groups. The following deltas were obtained-SBP peak in awake period (+9.3mmHgVs-7.5mmHg) (p<0.05, great ES); SBP peak during sleeping period (+2.3mmHgVs-6.8mmHg) (p<0.05, moderate ES); and DBP peak during awake period (+3.2mmHgVs-4.7mmHg) (p<0.05, great ES), in control and intervention groups, respectively. For postural angles, 33% of SBP were explained by anterior body shift. For DBP, 46% and 55% were explained by Knee and Ankle Angles, respectively. CONCLUSIONS: PRI reduced SBP and DBP peaks during awake period, with no effect on BP average. Even though PRI has not shown any improvement in overall posture, anterior body displacement and knee and ankle angles would solely explain 33-55% of the highest BP.