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February 20, 2023
3 minute read
Source/Disclosures
Disclosures:
The authors report no relevant financial information. Girard reports receiving research funding from Ceribell and the NIH, receiving consulting fees from the pharmaceutical group Haisco, and serving on the advisory board of Lungpacer Medical. Pandharipande reports receiving study money from the NIH by participating in data safety advisory/oversight committees.
According to a study published in THE Lancet Respiratory Medicine.
“The study’s finding of the impact of physical activity on cognition expands our knowledge of this important relationship,” John P. Kress, MD, director of the medical ICU at the University of Chicago Medicine, told Healio.
Data are from Patel BK, et al. Respir Med Lancet. 2023;doi:10.1016/S2213-2600(22)00489-1.
In a single-center parallel randomized controlled trial, Kress and colleagues analyzed 198 functionally independent adults on mechanical ventilation in the ICU for less than 96 hours, with at least 24 additional hours planned, to assess whether early mobilization may reduce the incidence of cognitive impairment 1 year after hospital discharge.
Researchers randomly assigned patients 1:1 to receive either early mobilization, which included physical therapy and occupational therapy within the first 96 hours of mechanical ventilation (n=99; mean age, 57.9 years; 59% men), or usual care (n = 99; mean age 54.5 years; 56% men).
At discharge from hospital and 1 year after discharge, researchers assessed neuromuscular weakness, institution-free days, functional independence, quality of life, and cognitive impairment, defined as a cognitive assessment score of Montreal less than 26. Cognitive impairment at 1 year—for which 89% of the early mobilization group and 88% of the usual care group had data—served as the study’s primary endpoint.
The median time from intubation to first therapy session was shorter for those receiving early mobilization (1.1 days; interquartile range [IQR]0.8-2) than for those receiving usual care (4.7 days; IQR, 3.3-6.8; P < .0001).
On leaving the hospital, cognitive impairment occurred in more patients in the usual care group than in the early mobilization group (69% versus 54%; difference = -15.2%; 95% CI, -28.6% to -1.7% ; P = 0.029).
Similarly, at 1 year, researchers found fewer patients with cognitive impairment in the early mobilization group than in the usual care group (24% versus 43%; absolute difference = -19.2%; 95% CI %, -32.1 to -6.3%; P = 0.0043).
With early mobilization, the researchers found a 19% reduction (RR=0.81; 95% CI, 0.68-0.96) in the risk of cognitive impairment.
“Early mobilization to intensive care is extremely difficult and requires a dedicated team,” Kress told Healio. “Time is running out because waiting several days to start will lead to failure, which happened in the usual care team study – the intervention was delayed.”
Compared with patients receiving usual care, fewer patients receiving early mobilization had ICU acquired weakness at 1 year (0% versus 14%; difference = -14.1%; 95% CI, -21 to -7 ,3; P = .0001).
Quality of life tests also demonstrated that the early mobilization group had better physical component scores compared to patients in the usual care group (median, 52.4; IQR, 45.3-56.8 vs. 41. 1;IQR, 31.8-49.4; P < 0.0001), although the researchers found no significant difference in functional independence rate (65% versus 62%; difference = 3%, 95% CI, -10.4 to 16.5% ) and scores for the mental component of quality of life (median 55.9; IQR, 50.2-58.9 versus 55.2; IQR, 49.5-59.7).
Six patients receiving early mobilization experienced adverse events compared to no patients in the usual care group (P = 0.029). These included tachycardia in two patients, and hypotension, tachypnea, oxygen desaturation, arterial catheter removal, and rectal tube removal in one patient each.
“In future studies, we need to determine which patients are most likely to benefit from an intervention that comes from limited resources (i.e. we don’t have an unlimited number of physiotherapists and occupational therapists to ICU),” Kress told Healio.
This study by Kress and colleagues adds new evidence to the literature on the benefits of early mobilization, according to an accompanying editorial in Timothy D. Girard, MD, MSCI, assistant professor of medicine at the University of Pittsburgh School of Medicine, and Practice P. Pandharipande, MD, MSCI, professor of anesthesiology and surgery at Vanderbilt University Medical Center.
“These results add to a growing body of evidence showing that mobilization as early as possible, when combined with mild sedation, avoidance of benzodiazepines and other risk factors for delirium, improves outcomes for patients treated in the ICU,” Girard and Pandharipande wrote. “Specifically, these results are the first from a randomized controlled trial linking early mobilization to improved long-term cognitive and physical outcomes, which are patient-centered and prioritized by many patients over survival.”
For more information:
John P. Kress, MD, can be attached to [email protected].
Reference:
Perspective
Carol L. Hodgson, PhD, FACP, FAHMS
There is an urgent need for more data on the long-term functional outcomes of survivors of critical illnesses and on early interventions that may reduce long-term deficits. This study aimed to fill these knowledge gaps.
Overall, the authors found that early mobilization was associated with improved cognitive function at 12 months. These results are surprising because previous systematic reviews were unable to demonstrate an effect of early mobilization on cognitive function due to heterogeneity of interventions and small sample sizes.
The authors acknowledge that the single-center design, with large effect sizes and small sample size, limits the generalizability of their results. Indeed, these results are not consistent with previous studies or a recent international multicenter trial that included 750 patients randomly assigned to early mobilization versus standard care and found no difference in cognitive function at 6 months ( the TEAM trial).
The difference in results between Patel and colleagues’ study and other trials may be due to the difference in the usual care arm. This study provided very limited mobilization to patients assigned to usual care, which is not consistent with international guidelines or current clinical practice worldwide. Only 6% of patients in the usual care group were mobilized to the intensive care unit, whereas in the TEAM trial, 77% of patients in the usual care group stood and 41% of patients walked. Differences in usual care may be due to the fact that Patel and colleagues’ study lasted 8 years; therefore, it began over a decade ago and before most current guidelines were developed.
Another important limitation of the study includes that there was only a fraction of the cohort available for assessment of cognitive function at 12 months (n=127 of 198; 64%), which may have resulted in responder bias.
This interesting study provided much-needed long-term follow-up data for cognitive function after early ICU mobilization. Although the results are promising, the lack of early mobilization in the usual care arm and the small sample size with a large amount of missing data for the primary outcome mean that the results need to be replicated in a larger study before Implementation.
Reference:
Hodgson CL, et al. NOT English JMed. 2022;doi:10.1056/NEJMoa2209083.
Carol L. Hodgson, PhD, FACP, FAHMS
Head, Division of Clinical Trials and Cohort Studies School of Public Health and Preventive Medicine, Monash University
Disclosures: Hodgson reports receiving an investigator’s grant from the National Health and Medical Research Council of Australia.
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