A study of Chinese stroke patients showed that starting rehabilitation within 48 hours for brain hemorrhage improved patients’ survival and functional prognosis at 6 months. Jue Wang, a professor at Xi’an Jiaotong University in Shanxi province, China, and colleagues wrote in the December issue of Stroke that patients receiving standard treatment who delayed the start of rehabilitation by a week or more had a 4-fold higher mortality rate during the 6-month follow-up period (corrected HR 4.44, 95% CI, 1.24-15.87). The editors of Medical Pulse have translated and compiled this study to share with you.
Several trials have shown that very early physical rehabilitation improves motor recovery and reduces mental, functional, and neurological disability in patients with ischemic stroke, the researchers write. This randomized controlled trial is one of the first to compare very early rehabilitation (VER) with standard treatment in a large number of patients with cerebral hemorrhage (ICH). In addition to improved survival, ICH patients who started physical rehabilitation within 48 hours had shorter hospital stays, reported higher quality of life at 6 months, were independently active every day and had an improved mental health prognosis compared to patients who received standard treatment. Many of the benefits of very early rehabilitation for patients with ICH in the trial underscore the need for further research in this area, the researchers said. We need to conduct larger trials in multiple countries in multiple settings. Stroke researcher Julie Bernhard, who was not involved in the trial, agreed with the statement that more research is needed on the safety and prognosis of VER in patients with ICH.
Bernhardt (associate professor at the Floridian Society of Neurological and Mental Health in Melbourne, Australia) led the Very Early Recovery Trial (AVERT), one of the largest acute stroke recovery trials that has been started with more than 2,000 participants. 259 ICH stroke patients. A phase III trial of AVERT is in preparation, and researchers hope to report findings on the effectiveness and cost of very early stroke rehabilitation in early 2016, she added, adding that the study plans to begin subgroup analyses. Wang and her colleagues write that at least 30 percent of stroke cases in China involve brain hemorrhage, compared with about 15 percent in Western countries.
Study overview
ICH cases are more severe than ischemic strokes and have a less favorable functional prognosis. Studies have shown that patients with ICH are less likely to receive early rehabilitation, and clinical guidelines for the management of ICH recommend close monitoring and strict blood pressure control early after the onset of ICH. This may indirectly promote early and aggressive treatment, although the guidelines also recommend that rehabilitation should be initiated as early as possible. To better understand the impact of VER on the prognosis of patients with ICH, researchers conducted a multicenter, randomized, controlled trial of patients who had their first episode of ICH and were admitted to the hospital no more than 48 hours after onset.
The 243 patients in the trial were diagnosed with ICH after MRI or X-ray tomography techniques and had no contraindications to exercise within 48 hours of stroke onset. Recruited patients had a Fugl-Meyer stroke deficit score between 27 and 90, excluding patients with very small or very severe injuries. Both groups received standard treatment in the neurology ward or stroke rehabilitation unit, which included stretching and other appropriate exercises, neuromuscular electrical stimulation, and functional training in which patients were instructed to do repetitive and systematic training tasks such as moving, grasping, and toe tapping. Rehabilitation of control patients began 1 week or more after stroke admission, whereas VER patients began rehabilitation immediately within 48 of the ICH episode.
The primary endpoint was death at 6 months, and secondary endpoints were assessed by questionnaires administered at 3- and 6-month follow-up, including patients’ quality of life functional performance and anxiety status. there were no statistically significant differences in baseline characteristics between the VER and standard treatment groups.
The mean length of hospital stay was 10 days less in the trial group – 24 days (SD 11.2 days) in the VER group: 34 days (SD 15.1 days) in the standard treatment group (p<0.001). In-hospital complications were 73 (60.3%) in the standard treatment group and 64 (53.3%) in the VER group (P=0.318). the number of patients reporting adverse events during the 6-month period after the CH episode was significantly higher in the standard treatment group (n=90 [83%]: n=37 [31%]; P<0.001). Adverse events included any medical problem such as early neurodegeneration, falls, seizures, infections, bed sores, or psychological problems. There were no statistically significant differences in secondary stroke patients between the two groups during the study period.
At six months, there were three deaths in the VER group and 12 deaths in the standard treatment group (HR 4.44; 95% CI 1.24-15.87 after correction for heart valve disease and age). six months after ICH, the trial group had a better physical health-related survival quality score, with a difference of six points from the control group (95% CI 4.2).
A study of Chinese stroke patients showed that starting rehabilitation within 48 hours for cerebral hemorrhage improved the survival and functional prognosis of patients at six months. Jue Wang, a professor at Xi’an Jiaotong University in Shanxi Province, China, and colleagues wrote in the December issue of Stroke that patients receiving standard treatment who delayed the start of rehabilitation by a week or more had a 4-fold higher mortality rate at 6-month follow-up (corrected HR
4.44, 95% CI, 1.24-15.87). This study has been translated and compiled by the editors of Medical Pulse and is shared with you.
Study Background
Several trials have shown that very early physical rehabilitation improves motor recovery and reduces mental, functional, and neurological disability in patients with ischemic stroke, the researchers write. This randomized controlled trial is one of the first to compare very early rehabilitation (VER) with standard treatment in a large number of patients with cerebral hemorrhage (ICH). In addition to improved survival, ICH patients who started physical rehabilitation within 48 hours had shorter hospital stays, reported higher quality of life at 6 months, were independently active every day and had an improved mental health prognosis compared to patients who received standard treatment. Many of the benefits of very early rehabilitation for patients with ICH in the trial underscore the need for further research in this area, the researchers said. We need to conduct larger trials in multiple countries in multiple settings. Stroke researcher Julie Bernhard, who was not involved in the trial, agreed with the statement that more research is needed on the safety and prognosis of VER in patients with ICH.
Bernhardt (associate professor at the Floridian Society of Neurological and Mental Health in Melbourne, Australia) led the Very Early Recovery Trial (AVERT), one of the largest acute stroke recovery trials that has been started with more than 2,000 participants. 259 ICH stroke patients. A phase III trial of AVERT is in preparation, and researchers hope to report findings on the effectiveness and cost of very early stroke rehabilitation in early 2016, she added, adding that the study plans to begin subgroup analyses. Wang and her colleagues write that at least 30 percent of stroke cases in China involve brain hemorrhage, compared with about 15 percent in Western countries.
Study overview
ICH cases are more severe than ischemic strokes and have a less favorable functional prognosis. Studies have shown that patients with ICH are less likely to receive early rehabilitation, and clinical guidelines for the management of ICH recommend close monitoring and strict blood pressure control early after the onset of ICH. This may indirectly promote early and aggressive treatment, although the guidelines also recommend that rehabilitation should be initiated as early as possible. To better understand the impact of VER on the prognosis of patients with ICH, researchers conducted a multicenter, randomized, controlled trial of patients who had their first episode of ICH and were admitted to the hospital no more than 48 hours after onset.
The 243 patients in the trial were diagnosed with ICH after MRI or X-ray tomography techniques and had no contraindications to exercise within 48 hours of stroke onset. Recruited patients had a Fugl-Meyer stroke deficit score between 27 and 90, excluding patients with very small or very severe injuries. Both groups received standard treatment in the neurology ward or stroke rehabilitation unit, which included stretching and other appropriate exercises, neuromuscular electrical stimulation, and functional training in which patients were instructed to do repetitive and systematic training tasks such as moving, grasping, and toe tapping. Rehabilitation of control patients began 1 week or more after stroke admission, whereas VER patients began rehabilitation immediately within 48 of the ICH episode.
The primary endpoint was death at 6 months, and secondary endpoints were assessed by questionnaires administered at 3- and 6-month follow-up and included patients’ functional performance in quality of life and anxiety status. there were no statistically significant differences in baseline characteristics between the VER and standard treatment groups. -8.7), mental health-related quality of survival scores were also better, with a difference of 7 points (95% CI 4.5-9.5), a difference of 13 points in Barthel Index scores (95% CI 6.8-18.3), and a difference of 6 points in anxiety self-assessment scales (95% CI
-8.3 to -4.4).
Study discussion
The researchers say that a limitation of the study was the absence of baseline information on important predictors of death, such as hematoma volume and hematoma site details, and the fact that the inclusion of patients in the study was partially dependent on clinical judgment. They write that while these should not bias the results, they may affect extrapolation of the study because physicians may have different subjective criteria. Bernhardt notes that we have to be cautious in interpreting trial results, in part because the intervention methods and primary study outcomes are not clearly defined. It is indeed positive that many of the early recovery trials came from China, she noted. However, we still need to improve trial reporting standards before we can be confident that we are finding evidence to guide practice.
In a review of clinical trials published in 2013, Bernhardt and her colleagues wrote that post-stroke rehabilitation is not standardized in China and that no untreated controlled trials have been identified until recently. Bernhardt and colleagues’ analysis included 37 Chinese randomized trials of very early recovery after stroke.
Although the combined data showed an advantage of rehabilitation over no rehabilitation, the researchers concluded that the quality of reporting was low and the timing of rehabilitation initiation was unclear. The researchers concluded that we need to reach consensus on standard data for rehabilitation trials, including baseline data, primary and secondary outcomes, and treatment interventions. This would be very helpful for future studies, reviews and meta-analyses.