Acute High-risk Abdominal Surgery (AHA) Clinical Trial
Official title:
Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study
| Verified date | January 2019 |
| Source | Hvidovre University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 21, 2018 |
| Est. primary completion date | December 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Hvidovre University Hospital | Hvidovre |
| Lead Sponsor | Collaborator |
|---|---|
| Morten Tange Kristensen PT, PhD |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Barriers to mobilization | Self-reported barriers to mobilization during hospitalization. | Up to 7 days after surgery | |
| Other | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Postoperative Pulmonary complication | The occurrence of postoperative pulmonary complication defined as Clavien-Dindo classification higher than grade 1 | Up to 2 weeks after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 24-hour physical activity (minutes per day) | Accelerometer recording time spent in lying, sitting and standing/walking. | Up to 7 days after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |