2. Materials and Methods
high-density lipoprotein, hypertension
BLOOD, SECONDARY, HYPERTENSION, HEART
We conducted this pilot study using a nonblinded randomized controlled trial (RCT) design at the Medical Department of Social Home Care for older adults in Makkah, Saudi Arabia, from January 2021 to March 2021. The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of King Saud University (E-20-5451) and the Ministry of Human Resource and Social Development, Social Welfare and Family Agency (78891). This study was registered with the ISRCTN registry (ISRCTN50726324). We opted for a nonblinding RCT design based on the recommendation that blinding should not be a decisive factor in assessing bias in a rehabilitation context [Sedentary men or women, aged 60 to 85, with hypertension and living in social home care were eligible. We defined hypertension as systolic blood pressure ≥130 mmHg and diastolic blood pressure ≥80 mmHg [We randomly divided participants who complied with the inclusion criteria into experimental and control groups, as shown in We assessed the primary and secondary outcomes at baseline and after the eight-week aerobic exercise training program. We determined the primary outcome of resting blood pressure by evaluating systolic and diastolic blood pressure using a conventional mercury sphygmomanometer (Rossmax Swiss GmbH, Heerbrugg, Switzerland). To assess systolic and diastolic blood pressure, we instructed all participants to cease smoking and drinking caffeine beverages 10 h before measurement and to empty their bladder. Participants were allowed to sit comfortably on a chair for at least 15 min with the back straight, supported, feet flat on the floor, legs not crossed, and arms supported on a flat surface. Blood pressure was measured twice, two minutes apart, and on two different occasions from both arms. We used the highest reading from the mean of the two readings as the blood pressure value. The mercury sphygmomanometer is valid, reliable, and considered the gold standard for measuring blood pressure [The secondary outcomes were heart rate, body fat, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and functional status. We assessed the resting heart rate using heart rate monitors when the participants were calm, relaxed, sitting, or lying. The term “resting heart rate” describes the heartbeat when it pumps the least blood required at rest. Heart rate monitors detect and measure heart or pulse rate and have proven to be accurate and valid tools [According to the American College of Sports Medicine guidelines [In the first week, participants started from 20 min with 30% of their heart rate and progressed gradually to 45 min with 50%. For the duration of each session, a 10 min warm-up and cool-down routine was included. We used a heart rate monitor to maintain aerobic exercise intensity during training and prevent excessively elevated heart rate of a maximum of 160 beats per minute (bpm) [The study sample size was calculated based on the inconsistent results of RCTs conducted on older adults in different settings and the divergent conclusions of the meta-analyses findings [We evaluated the dependent variables’ normality distribution and homogeneity of variance using the Kolmogorov–Smirnov and Levene’s tests, respectively. Descriptive statistics were presented as mean and standard deviation (SD) in total and for both experimental and control groups. The change in both the primary and secondary outcomes between the groups was analyzed using a nonparametric statistical test of the Mann–Whitney U test because of the limited sample size of this study. The change in the primary and secondary outcomes within groups was analyzed using a nonparametric statistical test of the Wilcoxon signed-rank test. Significance between groups was determined using an independent t-test, whereas a dependent sample test was used for within-group significance determination. The statistics were presented in mean and standard deviations (SD), along with 95% confidence interval (95% CI). All analyses were performed using IBM SPSS software (IBM, SPSS Inc., Armonk, NY, USA). Statistical significance was defined as 