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Completed

NCT Number: NCT03662932

Early Mobilization Following Emergency Abdominal Surgery

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.

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Key information

Conditions

Acute High-risk Abdominal Surgery (AHA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Mobilization within 24 hours after surgery assessed by CAS

    Time frame: Up to 24 hours after surgery

    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.

  2. Time out of bed (minutes per day) assessed by a accelerometer

    Time frame: Up to 7 days after surgery

    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.

  3. Mobilization 4 times a day registered in a journal

    Time frame: Up to 7 days after surgery

    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.

  4. Able to complete the outcome measures: NRS, VAFS, CST, Peakflow and EQ-5D-5L

    Time frame: Up to 7 days after surgery

    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.

Secondary outcomes

  1. Postoperative Pulmonary complication

    Time frame: Up to 2 weeks after surgery

    The occurrence of postoperative pulmonary complication defined as Clavien-Dindo classification higher than grade 1

  2. Cumulated Ambulation Score (CAS, 0-6 points)

    Time frame: Up to 7 days after surgery

    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.

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

    Time frame: Up to 7 days after surgery

    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.

  4. 30-second Chair Stand Test (CST)

    Time frame: Up to 7 days after surgery

    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.

  5. 24-hour physical activity (minutes per day)

    Time frame: Up to 7 days after surgery

    Accelerometer recording time spent in lying, sitting and standing/walking.

  6. Pulmonary function assessed by Peak flow meter

    Time frame: Up to 7 days after surgery

    Measure of a participants maksimum speed of exspiration assessed by a peak flow meter

  7. Visual Analog Fatigue Scale (VAFS, 0-10 points)

    Time frame: Up to 7 days after surgery

    Intensity of fatigue after surgery. Scale range is 0-10 points and higher scores indicate higher degree of fatigue.

  8. Pain assessed by Numeric Rating scale (NRS, 0-10 points)

    Time frame: Up to 7 days after surgery

    Self-reported measure of pain intensity. Scale range is 0-10 points and higher scores indicate higher degree of pain.

  9. Health-related quality of life assessed by EQ-5D-5L (0-100 points)

    Time frame: Up to 7 days after surgery

    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.

Other outcomes

  1. Barriers to mobilization

    Time frame: Up to 7 days after surgery

    Self-reported barriers to mobilization during hospitalization.

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

    Time frame: Baseline

    Measure of pre-hospital walking functional level. Scale range is 0-9 points: higher scores indicating independent level of walking ability.

Sponsors and collaborators

Lead sponsor

Morten Tange Kristensen PT, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.