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Changing functional status within 6 months posttreatment is prognostic of overall survival in patients with head and neck cancer: NRG Oncology Study.
Eldridge, RC, Pugh, SL, Trotti, A, Hu, K, Spencer, S, Yom, SS, Rosenthal, D, Read, N, Desai, A, Gore, E, et al
Head & neck. 2019;(11):3924-3932
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Abstract
BACKGROUND Is posttreatment functional status prognostic of overall survival in patients with head and neck cancer (HNC). METHODS In an HNC clinical trial, 495 patients had two posttreatment functional assessments measuring diet, public eating, and speech within 6 months. Patients were grouped by impairment (highly, moderately, modestly, or not impaired) and determined if they improved, declined, or did not change from the first assessment to the second. Multivariable Cox models estimated overall mortality. RESULTS Across all three scales, the change in posttreatment patient function strongly predicted overall survival. In diet, patients who declined to highly impaired had three times the mortality of patients who were not impaired at both assessments (hazard ratio [HR] = 3.60; 95% confidence interval, 2.02-6.42). For patients improving from highly impaired, mortality was statistically similar to patients with no impairment (HR = 1.38; 95% CI, 0.82-2.31). CONCLUSIONS Posttreatment functional status is a strong prognostic marker of survival in patients with HNC.
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Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage]).
Hänggi, D, Etminan, N, Aldrich, F, Steiger, HJ, Mayer, SA, Diringer, MN, Hoh, BL, Mocco, J, Faleck, HJ, Macdonald, RL, et al
Stroke. 2017;(1):145-151
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Abstract
BACKGROUND AND PURPOSE We conducted a randomized, open-label, phase 1/2a, dose-escalation study of intraventricular sustained-release nimodipine (EG-1962) to determine safety, tolerability, pharmacokinetics, and clinical effects in aneurysmal subarachnoid hemorrhage. METHODS Subjects with aneurysmal subarachnoid hemorrhage repaired by clipping or coiling were randomized to EG-1962 or enteral nimodipine. Subjects were World Federation of Neurological Surgeons grade 2 to 4 and had an external ventricular drain. Cohorts of 12 subjects received 100 to 1200 mg EG-1962 (9 per cohort) or enteral nimodipine (3 per cohort). The primary objective was to determine the maximum tolerated dose. RESULTS Fifty-four subjects in North America were randomized to EG-1962, and 18 subjects were randomized to enteral nimodipine. The maximum tolerated dose was 800 mg. One serious adverse event related to EG-1962 (400 mg) and 2 EG-1962 dose-limiting toxicities were without clinical sequelae. There was no EG-1962-related hypotension compared with 17% (3/18) with enteral nimodipine. Favorable outcome at 90 days on the extended Glasgow outcome scale occurred in 27/45 (60%, 95% confidence interval 46%-74%) EG-1962 subjects (5/9 with 100, 6/9 with 200, 7/9 with 400, 4/9 with 600, and 5/9 with 800 mg) and 5/18 (28%, 95% confidence interval 7%-48%, relative risk reduction of unfavorable outcome; 1.45, 95% confidence interval 1.04-2.03; P=0.027) enteral nimodipine subjects. EG-1962 reduced delayed cerebral ischemia (14/45 [31%] EG-1962 versus 11/18 [61%] enteral nimodipine) and rescue therapy (11/45 [24%] versus 10/18 [56%]). CONCLUSIONS EG-1962 was safe and tolerable to 800 mg, and in this, aneurysmal subarachnoid hemorrhage population was associated with reduced delayed cerebral ischemia and rescue therapy. Overall, the rate of favorable clinical outcome was greater in the EG-1962-treated group. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01893190.
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The effects of a constant sprint-to-rest ratio and recovery mode on repeated sprint performance.
Abt, G, Siegler, JC, Akubat, I, Castagna, C
Journal of strength and conditioning research. 2011;(6):1695-702
Abstract
It is unclear if a constant sprint-to-rest ratio allows full performance recovery between repeated sprints over different distances. This is important for the development of sprint-training programs. Additionally, there is conflicting evidence on whether active recovery enhances sprint performance. Three repeated sprint protocols were used (22 × 15, 13 × 30, and 8 × 50 m), with each having an active and passive recovery. Each trial was conducted with an initial sprint-to-rest ratio of 1:10. Repeated sprints were analyzed by comparing the first sprint to the last sprint. For the 15-m trials, there were no significant main effects for recovery or time and no significant interaction. For the 30-m trials, there was no main effect for recovery, but a main effect for time (F[1,10] = 15.995, p = 0.003; mean difference = 0.20 seconds, 95% confidence interval [CI] = 0.09-0.31 seconds, d = 1.4 [large effect]). There was no interaction of recovery and time in the 30-m trials. For the 50-m trials, there was no main effect for recovery, but a main effect for time (F[1,10] = 34.225, p = 0.0002; mean difference = 0.39 seconds, 95% CI = 0.24-0.55 seconds, d = 1.3 [large effect]). There was no interaction of recovery and time in the 50-m trials. The results demonstrate that a 1:10 sprint-to-rest ratio allows full performance recovery between 15-m sprints, but not between sprints of 30 or 50 m, and that recovery mode did not influence repeated sprint performance.
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Stressful life events predict delayed functional recovery following treatment for mania in bipolar disorder.
Yan-Meier, L, Eberhart, NK, Hammen, CL, Gitlin, M, Sokolski, K, Altshuler, L
Psychiatry research. 2011;(2-3):267-71
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Abstract
Identifying predictors of functional recovery in bipolar disorder is critical to treatment efforts to help patients re-establish premorbid levels of role adjustment following an acute manic episode. The current study examined the role of stressful life events as potential obstacles to recovery of functioning in various roles. 65 patients with bipolar I disorder participated in a longitudinal study of functional recovery following clinical recovery from a manic episode. Stressful life events were assessed as predictors of concurrent vs. delayed recovery of role functioning in 4 domains (friends, family, home duties, work/school). Despite clinical recovery, a subset of patients experienced delayed functional recovery in various role domains. Moreover, delayed functional recovery was significantly associated with presence of one or more stressors in the prior 3 months, even after controlling for mood symptoms. Presence of a stressor predicted longer time to functional recovery in life domains, up to 112 days in work/school. Interventions that provide monitoring, support, and problem-solving may be needed to help prevent or mitigate the effects of stress on functional recovery.
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Effect of L-ornithine hydrochloride ingestion on intermittent maximal anaerobic cycle ergometer performance and fatigue recovery after exercise.
Demura, S, Morishita, K, Yamada, T, Yamaji, S, Komatsu, M
European journal of applied physiology. 2011;(11):2837-43
Abstract
L-Ornithine plays an important role in ammonia metabolism via the urea cycle. This study aimed to examine the effect of L-ornithine hydrochloride ingestion on ammonia metabolism and performance after intermittent maximal anaerobic cycle ergometer exercise. Ten healthy young adults (age, 23.8 ± 3.9 year; height, 172.3 ± 5.5 cm; body mass, 67.7 ± 6.1 kg) with regular training experience ingested L-ornithine hydrochloride (0.1 g/kg, body mass) or placebo after 30 s of maximal cycling exercise. Five sets of the same maximal cycling exercise were conducted 60 min after ingestion, and maximal cycling exercise was conducted after a 15 min rest. The intensity of cycling exercise was based on each subject's body mass (0.74 N kg(-1)). Work volume (watt), peak rpm (rpm) before and after intermittent maximal ergometer exercise and the following serum parameters were measured before ingestion, immediately after exercise and 15 min after exercise: ornithine, ammonia, urea, lactic acid and glutamate. Peak rpm was significantly greater with L-ornithine hydrochloride ingestion than with placebo ingestion. Serum ornithine level was significantly greater with L-ornithine hydrochloride ingestion than with placebo ingestion immediately and 15 min after intermittent maximal cycle ergometer exercise. In conclusion, although maximal anaerobic performance may be improved by L-ornithine hydrochloride ingestion before intermittent maximal anaerobic cycle ergometer exercise, the above may not depend on increase of ammonia metabolism with L-ornithine hydrochloride.
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Alcohol consumption and functional outcome after stroke in men.
Rist, PM, Berger, K, Buring, JE, Kase, CS, Gaziano, JM, Kurth, T
Stroke. 2010;(1):141-6
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BACKGROUND AND PURPOSE Light-to-moderate alcohol consumption has been associated with reduced risk of total and ischemic stroke. However, data on the relationship between alcohol consumption and functional outcomes from stroke are sparse. METHODS Prospective cohort study among 21 860 men enrolled in the Physicians' Health Study who provided information on alcohol consumption at baseline and had no prior history of stroke or transient ischemic attack (TIA). Alcohol consumption was divided into 5 categories: <1 drink/wk, 1 drink/wk, 2 to 4 drinks/wk, 5 to 6 drinks/wk, and ≥1 drink/d. Possible functional outcomes included TIA, modified Rankin Scale (mRS)=0 to 1, mRS=2 to 3, and mRS=4 to 6. We used multinomial logistic regression to evaluate the relationship between levels of alcohol consumption and functional outcomes from stroke. RESULTS During a mean of 21.6 years of follow-up, 766 TIAs and 1393 strokes (1157 ischemic, 222 hemorrhagic, and 14 unknown type) occurred. Men who consumed 1 drink/wk had lowest associated odds for any outcome. Compared with men who did not experience a TIA or stroke and who consumed <1 drink/wk, men who consumed 1 drink/wk had odds ratio (95% CI) for total stroke of 0.85 (0.60 to 1.21) for mRS=0 to 1, 0.84 (0.64 to 1.10) for mRS=2 to 3, and 0.60 (0.37 to 0.97) for mRS=4 to 6. The odds ratio for TIA was 0.95 (0.73 to 1.23). The pattern of association did not substantially differ for ischemic and hemorrhagic stroke. Higher alcohol consumption showed no association with functional outcome after stroke. CONCLUSIONS Our data do not show strong associations between alcohol consumption and functional outcome after stroke. Modest beneficial associations exist with low alcohol consumption.
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Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study.
Chen, JY, Ko, TL, Wen, YR, Wu, SC, Chou, YH, Yien, HW, Kuo, CD
The Clinical journal of pain. 2009;(6):485-9
Abstract
OBJECTIVES Postoperative ileus (PI) is one of many common complications in major abdominal surgery. PI results in patient discomfort, increased gastrointestinal leakage, prolonged hospital stay, and increased medical expenses. In this study, we have investigated the morphine-sparing effects of ketorolac and its correlation with the duration of PI in patients with colorectal surgeries. METHODS We collected data from 102 patients who had received elective colorectal resection. The patients were randomly allocated into 2 groups and received intravenous patient-controlled analgesia (IVPCA) morphine (M group) or IVPCA morphine plus ketorolac (M+K group). Time-scale morphine consumption (per 12 h), recovery of bowel functions (the first bowel movement and passage of flatus), pain scores, and opioid-related side effects were then recorded. RESULTS Patients in the M+K group received 18.3% less morphine than those in the M group within 72 postoperative hours. The maximal opioid-sparing effects of ketorolac appeared in 12 to 24 postoperative hours. The onset of the first bowel movement and passage of flatus was significantly less in the M+K group than in the M group. The M group showed a 5.25 times greater risk of inducing PI, a result comparable with the M+K group in colorectal surgery patients. DISCUSSION The addition of ketorolac to IVPCA morphine has demonstrated a clear opioid-sparing effect and benefits in regards to the shortening of the duration of bowel immobility. We suggest that adding ketorolac to morphine IVPCA be included in the multimodal postoperative rehabilitation program for the early restoration of normal bowel function.
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Proximity of a lower third molar to the inferior alveolar canal as a predictor of delayed recovery.
Hull, DJ, Shugars, DA, White, RP, Phillips, C
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2006;(9):1371-6
Abstract
PURPOSE This study was designed to test the hypothesis that removal of lower third molars below the occlusal plane and in close proximity to the inferior alveolar canal (IAC) delays recovery after surgery as compared with lower third molars below the occlusal plane yet not close to the IAC. PATIENTS AND METHODS Recovery data were available for 579 patients enrolled in an institutional review board-approved clinical trial. After surgery a questionnaire designed to assess health-related quality of life (HRQOL) recovery was given to the patient to be completed each day for 14 days. At each postsurgery visit, clinical data were collected detailing healing and treatment. Based on radiographic findings, patients with at least 1 mandibular third molar below the occlusal plane were identified. Outcomes for patients with at least 1 radiographic sign indicating proximity of a lower third molar to the IAC were compared with those with none. Clinical and HRQOL outcomes were compared with Cochran-Mantel-Haensel statistics (P < .05). RESULTS No significant differences were found between groups for delayed clinical recovery. If radiographic signs for a patient at presurgery evaluation indicated close proximity of a lower third molar to the IAC, odds were significantly increased for delayed HRQOL recovery for worst pain, lifestyle, and oral function. CONCLUSION Our findings support the hypothesis that a presurgery finding of a lower third molar below the occlusal plane and in close proximity to the IAC is associated with patients' prolonged HRQOL recovery, but not a significant delay in clinical recovery.
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Creatine monohydrate supplementation does not improve functional recovery after total knee arthroplasty.
Roy, BD, de Beer, J, Harvey, D, Tarnopolsky, MA
Archives of physical medicine and rehabilitation. 2005;(7):1293-8
Abstract
OBJECTIVE To determine if creatine monohydrate supplementation can improve body composition and enhance recovery after total knee arthroplasty (TKA). DESIGN Randomized trial in which creatine monohydrate or placebo was administered. SETTING Public primary care facility. PARTICIPANTS Thirty-seven adults (17 men, 20 women) with osteoarthritis undergoing TKA. Intervention Subjects received creatine monohydrate (10 g/d x 10 d presurgery to 5 g/d x 30 d postsurgery) or placebo. MAIN OUTCOME MEASURES Body composition (dual-energy x-ray absorptiometry scanning), muscle metabolite concentrations (adenosine triphosphate, phosphocreatine, creatine, total creatine [phosphocreatine + creatine]), muscle histomorphometery, quadriceps, ankle dorsiflexion and handgrip strength, and functional capacity. All measurements were completed preoperatively (-7 d) and 30 days postoperatively, except for that of muscle metabolites. Muscle metabolite samples were collected during surgery (0 d) and at 30 days. RESULTS A significant decrease in quadriceps and ankle dorsiflexion strength was observed at 30 days postoperatively (P < .01). There were no significant effects of creatine monohydrate supplementation on any of the measured outcome variables. CONCLUSIONS Creatine monohydrate supplementation did not improve body composition or muscle strength when given before surgery, nor did it enhance recovery after TKA.
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Pain medication as an indicator of interference with lifestyle and oral function during recovery after third molar surgery.
Snyder, M, Shugars, DA, White, RP, Phillips, C
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2005;(8):1130-7
Abstract
Purpose This study was designed to assess the impact of taking pain medications, as a more comprehensive indicator of perceived pain, on the extent of interference with lifestyle and oral function during recovery after third molar surgery. Patients and Methods Recovery data after the removal of 4 third molars were available for patients enrolled in an institutional review board-approved, prospective, multicenter clinical trial. A self-administered health-related quality of life instrument, designed to assess a patients perception of recovery for pain, lifestyle, and oral function, was completed each postsurgery day (PSD) for 14 days. Taking pain medications was a proxy for a patients perceived level of pain, adding a more sensitive behavioral component to the report of pain. Each PSD day, the patients who thought that their pain was sufficient to require taking medications (an opioid, a nonsteroidal anti-inflammatory, or the combination) were compared with patients not taking pain medications. The extent of interference in lifestyle (daily activity, social life, recreation, sleep) and in oral function (eating, chewing, mouth opening) as self-reported on a scale of 1 (no trouble) to 5 (lots of trouble) were compared for those taking and not taking medications using Cochran-Mantel-Haenszel row mean statistics ( P < .05). Results The 445 study patients were mostly female (63%) and white (86%). Median age was 20 years (IQ, 18, 24 years). Median surgery time was 30 minutes (IQ, 20, 40 minutes). Both mandibular third molars were below the occlusal plane in 60%. Almost all patients took pain medication on PSD 1. By PSD 7, 48% of patients were taking pain medication, decreasing to 20% by PSD 11. Patients with pain sufficient to take an analgesic reported a greater extent of interference for all lifestyle and oral function measures. Recovery was significantly delayed for PSD 2 through 14 for patients who took medications ( P < 0.01). Recovery for females taking pain medications was significantly delayed compared with that for males. Conclusions Patients with pain sufficient to prompt taking pain medications were likely to report interference with recovery for lifestyle and oral function. A patients choice to take pain medication appears to be a better indicator of a patients perceived pain and the impact of that pain on recovery than numerical pain scales. This method provides more sensitive behavioral information during the period of recovery after third molar removal.