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Intensive physical therapy after emergency laparotomy: pilot phase of the incidence of complications following emergency abdominal surgery get exercising randomized controlled trial
Boden I, Sullivan K, Hackett C, Winzer B, Hwang R, Story D, Denehy L
Trauma Surgery & Acute Care Surgery 2022 Jun 1;92(6):1020-1030
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Postoperative pneumonia and delayed physical recovery are significant problems after emergency laparotomy. No randomized controlled trial has assessed the feasibility, safety, or effectiveness of intensive postoperative physical therapy in this high-risk acute population. METHODS: The internal pilot phase of the Incidence of Complications after Emergency Abdominal Surgery: Get Exercising (ICEAGE) trial was a prospective, randomized controlled trial that evaluated the feasibility, safety, and clinical trial processes of providing intensive physical therapy immediately following emergency laparotomy. Fifty consecutive patients were recruited at the principal participating hospital and randomly assigned to standard-care or intensive physical therapy of twice daily coached breathing exercises for 2 days and 30 minutes of daily supervised rehabilitation over the first 5 postoperative days. RESULTS: Interventions were provided exactly as per protocol in 35% (78 of 221 patients) of planned treatment sessions. Main barriers to protocol delivery were physical therapist unavailability on weekends (59 of 221 patients (27%)), awaiting patient consent (18 of 99 patients (18%)), and patient fatigue (26 of 221 patients (12%)). Despite inhibitors to treatment delivery, the intervention group still received twice as many breathing exercise sessions and four times the amount of physical therapy over the first 5 postoperative days (23 minutes (interquartile range 12 to 29 minutes) versus 86 minutes (interquartile range 53 to 121 minutes); p < 0.001). One adverse event was reported from 78 rehabilitation sessions (1.3%), which resolved fully on cessation of activity without escalation of medical care. CONCLUSION: Intensive postoperative physical therapy can be delivered safely and successfully to patients in the first week after emergency laparotomy. The ICEAGE trial protocol resulted in intervention group participants receiving more coached breathing exercises and spending significantly more time physically active over the first 5 days after surgery compared with standard care. It was therefore recommended to progress into the multicenter phase of ICEAGE to definitively test the effect of intensive physical therapy to prevent pneumonia and improve physical recovery after emergency laparotomy. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.
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