Clinical trial NCT03662932: Early Mobilization Following Emergency Abdominal Surgery
Official title: Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute High-risk Abdominal Surgery (AHA)
Keywords: Abdominal surgery
Early mobilization
Feasibility
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the included participants receive the intervention
Primary purpose: TREATMENT

Brief summary: Acute High-risk abdominal surgery (AHA) is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. A recent study revealed very low level of physical performance in the first postoperative week in patients undergoing AHA. Furthermore the included patients who were non-independently mobilized or had low level of 24-hour physical activity more often experienced a pulmonary complication. Studies examining the feasibility of early and intensive mobilization are needed, prior to investigating the effect of the intervention in an Randomised Controlled Trial. The purpose of this study is evaluating the feasibility of early and intensive mobilization during the first week postoperatively among patients who receive Acute High-Risk Abdominal Surgery (AHA). The aim is also to describe physical performance, physical activity, pulmonary function and health-related quality of life, as well as barriers to mobilization following AHA surgery.


Eligibility criteria: Inclusion Criteria:

• Patients (18 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).

Exclusion Criteria:

* Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention).
* Patients not able to give consent to participation in the study within 48 hours after surgery.

Primary outcomes:
measure: Mobilization within 24 hours after surgery assessed by CAS
timeFrame: Up to 24 hours after surgery
measure: Time out of bed (minutes per day) assessed by a accelerometer
timeFrame: Up to 7 days after surgery
measure: Mobilization 4 times a day registered in a journal
timeFrame: Up to 7 days after surgery
measure: Able to complete the outcome measures: NRS, VAFS, CST, Peakflow and EQ-5D-5L
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Postoperative Pulmonary complication
timeFrame: Up to 2 weeks after surgery
measure: Cumulated Ambulation Score (CAS, 0-6 points)
timeFrame: Up to 7 days after surgery
measure: Functional independence in Activity of Daily Living assessed by Barthel Index (BI, 0-100 points)
timeFrame: Up to 7 days after surgery
measure: 30-second Chair Stand Test (CST)
timeFrame: Up to 7 days after surgery
measure: 24-hour physical activity (minutes per day)
timeFrame: Up to 7 days after surgery
measure: Pulmonary function assessed by Peak flow meter
timeFrame: Up to 7 days after surgery
measure: Visual Analog Fatigue Scale (VAFS, 0-10 points)
timeFrame: Up to 7 days after surgery
measure: Pain assessed by Numeric Rating scale (NRS, 0-10 points)
timeFrame: Up to 7 days after surgery
measure: Health-related quality of life assessed by EQ-5D-5L (0-100 points)
timeFrame: Up to 7 days after surgery
Other outcomes:
measure: Barriers to mobilization
timeFrame: Up to 7 days after surgery
measure: Pre-hospital functional level assessed by New Mobility Score (NMS, 0-9 points)
timeFrame: Baseline
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Morten T Kristensen, PhD
role: STUDY_CHAIR
References: