Purpose The aim of this study was to compare biomechanical swallowing outcomes and perceived effort as well as detraining effects of the established Head Lift Exercise (HLE) and the novel Recline Exercise (RE) in healthy older adults. Method Twenty-two healthy older adults were randomized to perform either the RE or the HLE for a period of 6 weeks. Subjects underwent videofluoroscopic swallowing studies at 3 time points (baseline, postexercise, and following a 6-week detraining period). Primary outcome measures included biomechanical measures of superior and anterior hyoid excursion and upper esophageal sphincter opening, obtained using kinematic analyses on the recorded swallows. Perceived exertion ratings during exercise, as measured by the Borg scale, were included as a secondary outcome measure. Linear mixed-effects models were utilized to compare exercise groups and evaluation time points. Results The 2 exercise groups did not differ significantly in age, body mass index, or body fat percentage at baseline. Significant postexercise increases were seen in superior hyoid excursion, F (2, 36.7) = 24.01, p ≤ .0001, and anterior hyoid excursion, F (2, 36.7) = 5.40, p = .0088, for both exercise groups. Upper esophageal sphincter opening did not increase significantly following the exercise regimens, F (2, 36.5) = 2.14, p = .1322. Both groups displayed a significant decrease in perceived exertion levels over the course of the exercises, F (5, 98) = 23.73, p ≤ .0001. On average, Borg ratings were 20% lower for the RE group than the HLE group at all time points, F (5, 20) = 7.94, p = .0106, indicating that this exercise was perceived as easier to perform. Eighteen participants were followed after detraining, and no differences in detraining effects were seen between groups. In general, gains in biomechanical measures were better maintained on larger bolus types. Conclusions In healthy older adults, the HLE and the RE produced similar gains and detraining effects in biomechanical swallow outcomes. The RE exercise, however, required significantly less effort. These findings suggest that the RE is easier to perform for healthy older adults and thus may be a valuable treatment option for individuals who have difficulty performing the HLE. Further investigation in patients with dysphagia is warranted. Supplemental Material https://doi.org/10.23641/asha.7742897
Objectives: To investigate the clinical efficacy and safety of escin-containing gels in the topical treatment of blunt impact injuries. Methods: Competitors in soccer, handball, or karate competitions were enrolled within two hours of sustaining a strain, sprain, or contusion and treated three times with the trial gel within a period of eight hours. Patients were randomised to three parallel groups consisting of two active treatment gels, containing escin (1% or 2%), 5% diethylammonium salicylate, and 5000 IU heparin, or placebo gel. Tenderness produced by pressure was measured at 0 (baseline), 1, 2, 3, 4, 6, and 24 hours after enrolment (within two hours of the injury). Tenderness was defined as the amount of pressure (measured by a calibrated caliper at the centre of the injury) that first produced a pain reaction as reported by the patient. Results: A total of 158 patients were enrolled; 156 were evaluated in the intention to treat analysis. The primary efficacy variable was the area under the curve for tenderness over a six hour period. The gel preparations containing 1% and 2% escin were significantly more effective (a priori ordered hypotheses testing controlling the multiple α = 5% significance level) than placebo (p 1 = 0.0001 and p 2 = 0.0002 respectively). The treatment effects were 5.7 kp h/cm 2 (95% confidence interval (CI) 2.9 to 8.5) and 5.9 kilopond (kp) h/cm 2 (95% CI 2.9 to 8.8) between 1% escin and placebo and between 2% escin and placebo respectively. These results were supported by secondary efficacy variables. The time to reach the baseline contralateral tenderness value (resolution of pain) at the injured site was shorter in the treatment groups than in the placebo group (p<0.0001). Both active gel preparations produced more rapid pain relief than the placebo gel. No relevant differences were detected between the two active gels. The safety and tolerability of the escin-containing gels were excellent. Conclusions: Escin/diethylammonium salicylate/heparin combination gel preparations are effective and safe for the treatment of blunt impact injuries.
The aim of this confirmative, monocentre, double-blind, controlled clinical trial was to investigate whether different escin combinations show differences in comparison to placebo with regard to pain reactions in the topical treatment of sports injuries. A total of 126 patients with blunt injuries of the extremities were randomly allocated to four parallel groups: Reparil-Gel N (n = 32), Reparil-Gel (n = 31), Reparil-Sportgel (n = 32) and a placebo gel (n = 31). All patients were evaluated for efficacy (intention to treat) and tolerability. A per-protocol analysis was also carried out, in which 12 of the 126 patients were excluded due to protocol violations. The intention-to-treat and per-protocol analyses produced similar results. The patients had suffered contusions while participating in soccer, hockey, karate, tae-kwon-do, handball, American football, rugby or tennis. The measured variable was the pressure required at the centre of the lesion to elicit the first pain reaction (tenderness reaction) at measuring time 0 (baseline) and then 1, 2, 3, 4, 6 and 24 h after the injury. The primary variable was the area under the curve (AUC) for tenderness over a six-hour period. The mean AUC differed significantly in the four groups (Kruskal-Wallis test p = 0.0001). Then six pairwise comparisons of two treatment groups each were carried out using the Mann-Whitney test. To control the multiple significance level of 5%, the adjusted p-values according to the Holm-Shaffer method were used in these tests. The three active gels were significantly superior to the placebo gel (Mann-Whitney test, p = 0.0004 in each case) in terms of the AUC. There were no significant differences between the active test substances in terms of the primary variable. The intensity of the pain was also measured on a visual analogue scale (VAS). The pain diminished more rapidly with the Reparil gels than with the placebo. The tolerability of all test substances was good. No adverse events were observed in any of the 126 patients. Escin combination gels are more effective than a placebo and are also well tolerated. Therefore, they can be recommended for the treatment of blunt injuries caused during sports and leisure activities.
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