Early Mobilization Following Emergency Abdominal Surgery

NCT03662932 | Completed

• 1 other identifier: HH-AHA-FYS-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute High-risk Abdominal Surgery (AHA)

Keywords

Abdominal surgery; Early mobilization; Feasibility

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Postoperative Pulmonary complication

  Up to 2 weeks after surgery

• Cumulated Ambulation Score (CAS, 0-6 points)

  Up to 7 days after surgery

• Functional independence in Activity of Daily Living assessed by Barthel Index (BI, 0-100 points)

  Up to 7 days after surgery

• 30-second Chair Stand Test (CST)

  Up to 7 days after surgery

• 24-hour physical activity (minutes per day)

  Up to 7 days after surgery

Other Outcomes (2)

• Barriers to mobilization

  Up to 7 days after surgery

• Pre-hospital functional level assessed by New Mobility Score (NMS, 0-9 points)

  Baseline

Study Arms (1)

Early intensive mobilization

EXPERIMENTAL

Progressed mobilization from postoperative day 0.

Other: Early intensive mobilization

Interventions

Early intensive mobilization OTHER

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.

Early intensive mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Morten Tange Kristensen PT, PhD: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Denmark

Location

Study Officials

• Morten T Kristensen, PhD

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher, PT, Phd

Model Details: All the included participants receive the intervention

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 10, 2018
• Study Start: September 17, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

DK (1)