AIM: To define optimal early mobility intervention regimens for ischemic stroke patients of mild and moderate severity.
HYPOTHESES: Compared with a prespecified reference arm, the optimal dose regimen(s) will result in more participants experiencing little or no disability (mRS 0-2) at 3 months post-stroke (primary), fewer deaths at 3 months, fewer and less severe complications during the intervention period, faster recovery of unassisted walking, and better quality of life at 3 months (secondary). We also hypothesize that these regimens will be more cost-effective.
SAMPLE SIZE ESTIMATES: For the primary outcome, recruitment of 1300 mild and 1400 moderate participants will yield 80% power to detect a 10% risk difference.
METHODS AND DESIGN: Multi-arm multi-stage covariate-adjusted response-adaptive randomized trial of mobility training commenced within 48 h of stroke in mild (NIHSS 2) and hemorrhagic stroke. With four arms per stratum (reference arm retained throughout), only the single treatment arm demonstrating the highest proportion of favorable outcomes at the first stage will proceed to the second stage in each stratum, resulting in a final comparison with the reference arm. Three prognostic covariates of age, geographic region and reperfusion interventions, as well as previously observed mRS 0-2 responses inform the adaptive randomization procedure. Participants randomized receive prespecified mobility training regimens (functional task-specific), provided by physiotherapists/nurses until discharge or 14 days. Interventions replace usual mobility training. Fifty hospitals in seven countries (Australia, Malaysia, United Kingdom, Ireland, India, Brazil, Singapore) are expected to participate.
SUMMARY: Our novel adaptive trial design will evaluate a wider variety of mobility regimes than a traditional two-arm design. The data-driven adaptions during the trial will enable a more efficient evaluation to determine the optimal early mobility intervention for patients with mild and moderate ischemic stroke.
Materials and Methods: This study was aimed to identify the relationship between NS and HRQOL among young motorcycle riders (undergraduate university students) aged between 19 and 25 years (n = 301) through a cross-sectional questionnaire-based study, that is, Weinstein noise sensitivity scale and the World Health Organization Quality of Life. The effects of NS on HRQOL were assessed based on gender, the years of motorcycle driving experience, and noise sensitive among groups using one-way analysis of variances with an alpha value of 0.05.
Results: The results showed no significant difference in NS between males and females. On the other hand, motorcycle driving experience for <4 years displayed a higher tendency toward NS. Moreover, a significantly (P = 0.004) decreasing trend among low, moderate, and high NS with their respective HRQOL was observed, while a high NS showed significantly (P = 0.015) lower scores on the social domain of the quality of life.
Conclusion: The overall premise of the study has statistical significance and shows that individuals with high NS tend to have degraded HRQOL compared to individuals with low NS. Furthermore, in-depth studies are required from the other demographical background of participants to investigate the motorcyclist's NS and HRQOL as an integral requirement for the rider's safety and health.
METHODS: A multicentered, open-label, parallel group, prospective randomized controlled trial among patients suffering from CKD-associated pruritus with sleep disturbance, after randomization into control, and intervention group to be held at North West General Hospital and Research Center Peshawar, Pakistan and Institute of Kidney Diseases Peshawar, Pakistan.
RESULTS: The primary outcome is to investigate the effectiveness of zolpidem 10 mg and acupressure therapy on foot acupoints to improve the sleep quality and overall quality of life among hemodialysis patients suffering from CKD-associated pruritus. After baseline assessment by Urdu version of 5D itch scale and Urdu version of Pittsburgh Sleep Quality Index (PSQI) and Urdu EQ-5D 3L, the intervention group will be given zolpidem 10 mg oral tablets and control group with acupressure on both foots on KI-1 acupoints for total of 6 minutes. Assessment will be done at weeks 4 and 8 from baseline by using Urdu version of 5D itch scale and Urdu version of PSQI and Urdu EQ-5D 3L, whereas safety profiling of zolpidem 10 mg tablet at week 6 from baseline and acupressure acceptability at week 6 from baseline. Analysis of covariance will be used to examine the differences in treatment effects between the intervention and control groups.
CONCLUSION: Improvement of sleep quality and quality of life among patients with CKD-associated pruritus requires great importance. This study aims to improve the quality of sleep and quality of life among patients with hemodialysis suffering from CKD-associated pruritus.
MATERIALS AND METHODS: This is a retrospective study of patients with chronic refractory breathlessness and Modified Medical Research Council (mMRC) dyspnoea scale grade ≥ 2 who attended the BST clinic over 1 year period. BST consists of two clinic sessions 2 weeks apart. Data was retrieved from patients' medical notes and analysis done using Microsoft Excel.
RESULTS: A total of 21 patients were identified. Median age was 69 years with 52% of females. 72% had non-malignant diagnoses. Median Charlson's Comorbidity Index score was 6.5. Median mMRC dyspnoea scale was 3. 47.6% had long term oxygen usage. Median Australian Karnofsky Performance Scale (AKPS) was 65 and the median baseline breathlessness visual analogue scale (VAS) was 2. 62% completed two sessions, the remaining 38% completed only one session. Mean time from BST intervention to death was 18.26 weeks, median was 22 weeks. 72% died at home, whilst 28% died in the hospital. All the patients scored 4 (somewhat agree) and 5 (strongly agree) on the overall feedback score.
CONCLUSIONS: Development of a breathlessness intervention service is feasible in a resource limited setting and generally accepted by most patients. More research and prospective studies are needed to evaluate the effectiveness of BST in the future.