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Early Mobilization Following Emergency Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662932
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Morten Tange Kristensen PT, PhD, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute High-risk Abdominal Surgery (AHA) Other: Early intensive mobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All the included participants receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : December 21, 2018

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662932


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Morten Tange Kristensen PT, PhD
Investigators
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Study Chair: Morten T Kristensen, PhD Hvidovre University Hospital
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Responsible Party: Morten Tange Kristensen PT, PhD, Senior researcher, PT, Phd, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03662932    
Other Study ID Numbers: HH-AHA-FYS-02
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morten Tange Kristensen PT, PhD, Hvidovre University Hospital:
Abdominal surgery
Early mobilization
Feasibility