High Intensity Physical Rehabilitation Later Than 24 h Post Stroke Is Beneficial in Patients: A Pilot Randomized Controlled Trial (RCT) Study in Mild to Moderate Ischemic Stroke

Abstract

Objective: Very early mobilization was thought to contribute to beneficial outcomes in stroke-unit care, but the optimal intervention strategy including initiation time and intensity of mobilization are unclear. In this study, we sought to confirm the rehabilitative effects of different initiation times (24 vs. 48 h) with different mobilization intensities (routine or intensive) in ischemic stroke patients within three groups. Materials and Methods: We conducted a randomized and controlled trial with a blinded follow-up assessment. Patients with ischemic stroke, first or recurrent, admitted to stroke unit within 24 h after stroke onset were recruited. Eligible subjects were randomly assigned (1:1:1) to 3 groups: Early Routine Mobilization in which patients received < 1.5 h/d out-of-bed mobilization within 24-48 h after stroke onset, Early Intensive Mobilization in which patients initiated ≥3 h/d mobilization at 24-48 h after the stroke onset, and Very Early Intensive Mobilization in which patients received≥3 h/d mobilization within 24 h. The modified Rankin Scale score of 0-2 was used as the primary favorable outcome. Results: We analyzed 248 of the 300 patients (80 in Early Routine Mobilization, 82 in Very Early Intensive Mobilization and 86 in Early Intensive Mobilization), with 52 dropping out (20 in Early Routine Mobilization, 18 in Very Early Intensive Mobilization and 14 in Early Intensive Mobilization). Among the three groups, the Early Intensive Mobilization group had the most favorable outcomes at 3-month follow-up, followed by patients in the Early Routine Mobilization group. Patients in Very Early Intensive Mobilization received the least odds of favorable outcomes. At 3 month follow up, 53.5%, (n = 46) of patients with Early Intensive Mobilization showed a favorable outcome (modified Rankin Scale 0-2) (p = 0.041) as compared to 37.8% (n = 31) of patients in the Very Early Intensive Mobilization. Conclusions: Post-stroke rehabilitation with high intensity physical exercise at 48 h may be beneficial. Very Early Intensive Mobilization did not lead to a favorable outcome at 3 months. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR-ICR-15005992.

Keywords: acute care; early mobilization; intensity; ischemic stroke; rehabilitation.

Figure 1

Trial profile. ERM, Early Routine Mobilization; VEIM, Very Early Intensive Mobilization; EIM, Early Intensive Mobilization. Three hundred patients were assigned randomly (1:1:1) to three groups. Two hundred and forty-eight (82.7%) patients finished the training and follow-up assessment, 80 in ERM, 82 in VEIM and 86 in EIM groups, while 52 patients (20 in ERM, 18 in VEIM, and 14 in EIM) dropped out for various reasons. In total, 80 in ERM, 86 patients in EIM and 82 patients in VEIM finished the training and the follow-up, and were thus analyzed.

Figure 2

mRS shift: the percentage of patients achieving each mRS score at 3 months. ERM, Early Routine Mobilization; VEIM, Very Early Intensive Mobilization; EIM, Early Intensive Mobilization; mRS, modified Rankin Scale.