Acute High-risk Abdominal Surgery (AHA)NCT03662932
Early Mobilization Following Emergency Abdominal Surgery
A study testing Early intensive mobilization in people with Acute High-risk Abdominal Surgery (AHA), run by Morten Tange Kristensen PT, PhD at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute High-risk Abdominal Surgery (AHA)
- What is being tested?
- Early intensive mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Sep 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute High-risk Abdominal Surgery (AHA)
- Being tested
- Early intensive mobilization
- Keywords
- Abdominal surgery, Early mobilization, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intensive mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early intensive mobilization | Experimental | Progressed mobilization from postoperative day 0. Receives: Other: Early intensive mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days after surgery
Secondary outcomes (9)
Postoperative Pulmonary complication
The occurrence of postoperative pulmonary complication defined as Clavien-Dindo classification higher than grade 1
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days after surgery
24-hour physical activity (minutes per day)
Accelerometer recording time spent in lying, sitting and standing/walking.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start17 Sep 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute High-risk Abdominal Surgery (AHA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the included participants receive the intervention
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Tange Kristensen PT, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Tange Kristensen PT, PhD, Hvidovre University Hospital
- Investigators
- Morten T Kristensen, PhD, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662932
- Sponsor's protocol ID
- HH-AHA-FYS-02
- Status last verified
- Jan 2019
- First submitted
- 23 Aug 2018
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intensive Mobilization Following Acute High-risk Abdominal Surgery - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03662932
- Acronym / sponsor ID
- HH-AHA-FYS-02
- Conditions
- Acute High-risk Abdominal Surgery (AHA)
- Keywords
- Abdominal surgery, Early mobilization, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Morten Tange Kristensen PT, PhDUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the included participants receive the intervention
| Arm | Type | Receives |
|---|---|---|
| Early intensive mobilization | Experimental | Other: Early intensive mobilizationProgressed mobilization from postoperative day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (18 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early intensive mobilizationEarly 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. | Other | Early intensive mobilization |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Postoperative Pulmonary complication
Time frame: Up to 2 weeks after surgery
Cumulated Ambulation Score (CAS, 0-6 points)
Time frame: Up to 7 days after surgery
Functional independence in Activity of Daily Living assessed by Barthel Index (BI, 0-100 points)
Time frame: Up to 7 days after surgery
30-second Chair Stand Test (CST)
Time frame: Up to 7 days after surgery
24-hour physical activity (minutes per day)
Time frame: Up to 7 days after surgery
Pulmonary function assessed by Peak flow meter
Time frame: Up to 7 days after surgery
Visual Analog Fatigue Scale (VAFS, 0-10 points)
Time frame: Up to 7 days after surgery
Pain assessed by Numeric Rating scale (NRS, 0-10 points)
Time frame: Up to 7 days after surgery
Health-related quality of life assessed by EQ-5D-5L (0-100 points)
Time frame: Up to 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten T Kristensen, PhD study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intensive mobilization in people with Acute High-risk Abdominal Surgery (AHA), run by Morten Tange Kristensen PT, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobilization within 24 hours after surgery assessed by CAS (time frame: Up to 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.