Recruitment methods and yield rates in a clinical trial of physical exercise for older adults with hypertension-HAEL Study: a study within a trial.

BACKGROUND: Although the prevalence of hypertension is high in older adults, clinical trial recruitment is a challenge. Our main aim was to describe the HAEL Study recruitment methods and yield rates. The secondary objectives were to explore the reasons for exclusion and to describe the characteristics of the enrolled participants. METHODS: This is a descriptive study within a trial. The HAEL Study was a Brazilian randomized two-center, parallel trial with an estimated sample of 184 participants. The recruitment strategy was based on four methods: electronic health records, word of mouth, print and electronic flyer, and press media. The yield rate was the ratio of the number of participants who underwent randomization to the total number of volunteers screened, calculated for overall, per recruitment method, by study center and by age group and sex. Additionally, we described the reasons for exclusion in the screening phase, as well as the demographic characteristics of those enrolled. The data are presented in absolute/relative frequencies and mean ± standard deviation. RESULTS: A total of 717 individuals were screened, and 168 were randomized over 32 months. The yield rate was higher for word of mouth (30.1%) in the overall sample. However, press media contributed the most (39.9%) to the absolute number of participants randomized in the trial. The coordinating center and participating center differed in methods with the highest yield ratios and absolute numbers of randomized participants. The main reason for exclusion in the screening phase was due to the physically active status in those intending to participate in the study (61.5%). Out of 220 participants included, 52 were excluded mainly because they did not meet the eligibility criteria (26.9%). Most of the screened volunteers were women (60.2%) age 60-69 years (59.5%), and most of the randomized participants were Caucasian/white (78.0%). CONCLUSIONS: Multiple recruitment methods constituted effective strategies. We observed that approximately one of every four individuals screened was allocated to an intervention group. Even so, there were limitations in obtaining a representative sample of older Brazilian adults with hypertension. Data show an underrepresentation of race and age groups. TRIAL REGISTRATION: This SWAT was not registered.

High-velocity resistance training mitigates physiological and functional impairments in middle-aged and older adults with and without mobility-limitation.

The aim of the present study was to compare the neuromuscular, morphological, and functional responses to a high-velocity resistance training (HVRT) program between three cohorts: middle-aged adults (40-55 years, n = 18), healthy older adults (> 60 years, n = 18), and mobility-limited older adults (n = 8). Participants were tested before and after a 4-week control period and then assigned to a 12-week HVRT intervention. Investigated outcomes included ultrasound-derived muscle thickness and quality, maximal dynamic strength (1RM), maximal voluntary isometric contraction (MVIC), and muscle activation (sEMG), as well as muscle power and functional performance. After the intervention, quadriceps muscle thickness, 1RM, and sEMG improved in all three groups (all p < 0.05), whereas muscle quality improved only in middle-aged and older participants (p ≤ 0.001), and MVIC only in middle-aged and mobility-limited older adults (p < 0.05). With a few exceptions, peak power improved in all groups from 30-90% 1RM (p < 0.05) both when tested relative to pre-training or post-training 1RM workloads (all p < 0.05). Both mobility-limited older adults and older adults improved their short physical performance battery score (p < 0.05). Chair stand, stair climb, maximal gait speed, and timed up-and-go performance, on the other hand, improved in all three groups (p < 0.05), but no change was observed for habitual gait speed and 6-min walk test performance. Overall, our results demonstrate that a HVRT intervention can build a stronger foundation in middle-aged individuals so that they can better deal with age-related impairments at the same time that it can mitigate already present physiological and functional impairments in older adults with and without mobility-limitation.

Maximal Oxygen Uptake Is Underestimated during Incremental Testing in Hypertensive Older Adults: Findings from the HAEL Study.

PURPOSE: The present cross-sectional study aimed to investigate whether a maximal oxygen uptake (V˙O2max) verification phase (VER) could improve the accuracy of a previous graded exercise test (GXT) to assess individual V˙O2max in hypertensive individuals. METHODS: Thirty-three older adults with hypertension (24 women) taking part in the Hypertension Approaches in the Elderly Study (NCT03264443) were recruited. Briefly, after performing a treadmill GXT to exhaustion, participants rested for 10 min and underwent a multistage VER to confirm GXT results. Individual V˙O2max, RER, maximal heart rate (HRmax), and RPE were measured during both GXT and VER tests. Mean values were compared between bouts using paired sample t-tests, and V˙O2max was also compared between GXT and VER on an individual basis. RESULTS: Testing was well tolerated by all participants. Both absolute (P = 0.011) and relative (P = 0.014) V˙O2max values were higher in VER than that in GXT. RER (P < 0.001) and RPE (P = 0.002) were lower in VER, whereas HRmax (P = 0.286) was not different between the two trials. Individual V˙O2max comparisons revealed that 54.6% of the participants (18/33) achieved a V˙O2max value that was ≥3% during VER (mean = 13.5%, range = +3% to +22.1%, ES = 0.062), whereas 87.9% (29/33) of the tests would have been validated as a maximal effort if the classic criteria were used (i.e., V̇O2 plateau or at least two secondary criteria). CONCLUSION: In sedentary older individuals with hypertension, GXT to exhaustion underestimated V˙O2max in more than half of tested participants, even when established, but criticized criteria were used to confirm whether a maximal effort was attained. Using VER after GXT is a quick approach to assist with the verification of an individual's V˙O2max.