Early Mobilization Following Emergency Abdominal Surgery

Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Acute High-risk Abdominal Surgery (AHA)
• Intervention / Treatment: Other: Early intensive mobilization

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early intensive mobilization; Progressed mobilization from postoperative day 0.	Other: Early intensive mobilization; Early mobilization: mobilization with the hospital staff begins already on the day of surgery, and includes mobilization in and out of bed, rise up from a chair, standing and walking. Intensive mobilization: mobilization more than 4 times a day in the first postoperative week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobilization within 24 hours after surgery assessed by CAS	Percentage of participants that is mobilized within 24 hours after surgery assessed by the Cumulated Ambulation Score (CAS). Pre-defined criteria of feasibility; >=80% feasible, 60-79% potentially feasible, and <60% considered not feasible.	Up to 24 hours after surgery
Time out of bed (minutes per day) assessed by a accelerometer	Percentage of participants able to meet the predefined daily targets of time out of bed (minutes per day) assessed by a accelerometer recording time spent in lying, sitting and standing/walking. Pre-defined criteria of feasibility; >=80% feasible, 60-79% potentially feasible, and <60% considered not feasible.	Up to 7 days after surgery
Mobilization 4 times a day registered in a journal	Percentage of participants mobilized 4 times a day registered by the hospital staff in a journal. Pre-defined criteria of feasibility; >=80% feasible, 60-79% potentially feasible, and <60% considered not feasible.	Up to 7 days after surgery
Able to complete the outcome measures: NRS, VAFS, CST, Peakflow and EQ-5D-5L	Percentage of participants able to complete the selected outcome measures: Numeric Rating scale (NRS), Visual Analog Fatigue Scale (VAFS), 30-second Chair Stand Test (CST), Peakflow meter and health-related quality of life EQ-5D-5L. Pre-defined criteria of feasibility; >=80% feasible, 60-79% potentially feasible, and <60% considered not feasible.	Up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pulmonary complication	The occurrence of postoperative pulmonary complication defined as Clavien-Dindo classification higher than grade 1	Up to 2 weeks after surgery
Cumulated Ambulation Score (CAS, 0-6 points)	Evaluation of independence in basic mobility (in and out of bed, rise from a chair and walking). Scale range is 0-6 points: 0 points indicate that the participant can't be mobilized and 6 points indicate that the participant is mobilizied independently.	Up to 7 days after surgery
Functional independence in Activity of Daily Living assessed by Barthel Index (BI, 0-100 points)	Measure functional independence in Activity of Daily Living (ADL) in relation to transfer, mobility, stairs, dressing, feeding, grooming, bathing, toilet use and bowels and bladder function. Scale range is 0-100 points and lower scores indicates increased disability.	Up to 7 days after surgery
30-second Chair Stand Test (CST)	Test for lower body leg strength and endurance assessed by the 30-second Chair Stand Test (CST). Record the number of times the patient stands in 30 sec.	Up to 7 days after surgery
24-hour physical activity (minutes per day)	Accelerometer recording time spent in lying, sitting and standing/walking.	Up to 7 days after surgery
Pulmonary function assessed by Peak flow meter	Measure of a participants maksimum speed of exspiration assessed by a peak flow meter	Up to 7 days after surgery
Visual Analog Fatigue Scale (VAFS, 0-10 points)	Intensity of fatigue after surgery. Scale range is 0-10 points and higher scores indicate higher degree of fatigue.	Up to 7 days after surgery
Pain assessed by Numeric Rating scale (NRS, 0-10 points)	Self-reported measure of pain intensity. Scale range is 0-10 points and higher scores indicate higher degree of pain.	Up to 7 days after surgery
Health-related quality of life assessed by EQ-5D-5L (0-100 points)	Standardized instrument developed by the EuroQol Group as a measure of self-reported health-related quality of life. Scale range is 0-100 points: 0 points indicating the worst health the participant can imagine.	Up to 7 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to mobilization	Self-reported barriers to mobilization during hospitalization.	Up to 7 days after surgery
Pre-hospital functional level assessed by New Mobility Score (NMS, 0-9 points)	Measure of pre-hospital walking functional level. Scale range is 0-9 points: higher scores indicating independent level of walking ability.	Baseline

Collaborators and Investigators

• Sponsor: Morten Tange Kristensen PT, PhD
• Investigators: Study Chair: Morten T Kristensen, PhD, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ACTUAL): December 21, 2018
• Study Completion (ACTUAL): December 21, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Feasibility; Abdominal surgery; Early mobilization
• Other Study ID Numbers: HH-AHA-FYS-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No