Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000318583
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
8/04/2015
Date last updated
6/05/2021
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ICEAGE trial - Incidence of Complications following Emergency Abdominal surgery: Get Exercising.
Scientific title
ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): a pragmatic, multicentre, randomised controlled trial testing an enhanced physiotherapy program for the prevention of complications and improved physical recovery after emergency abdominal surgery.
Secondary ID [1] 283826 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ICEAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pulmonary complications following emergency upper abdominal surgery 290802 0
Condition category
Condition code
Surgery 291169 291169 0 0
Other surgery
Physical Medicine / Rehabilitation 291170 291170 0 0
Physiotherapy
Respiratory 291171 291171 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants as soon as practical after surgery will receive: 1) Non-restricted number of physiotherapist provided education and instruction sessions on postoperative recovery and complication prevention with breathing exercises and physical activity; 2) Daily physiotherapist supervised early rehabilitation sessions lasting at least 30-minutes; and, 3) at least four coached deep breathing and coughing exercise sessions in the first two postoperative days.
Rehabilitation program: Rehabilitation will consist of a combination of ambulation and non-ambulatory chair or bed-based exercises starting as soon as possible after surgery and continuing daily thereafter for at least the next five postoperative days or until at least five daily sessions are delivered. Exercises will be provided in a top-down hierarchical sequence starting each session with the maximum physical activity type the participant is able to attempt, starting from ambulation. Exercise delivery progresses sequentially down the protocol until at least 30-minutes of activity has been accumulated. For example, participants will first be assisted to ambulate for at least 15-minutes with a goal to achieve at least 30-minutes. If time ambulated is less than 30-minutes, the participant will attempt resistive lower limb exercises in standing for the remaining time or until fatigue limits performance. If time still remains less than 30-minutes, participants will attempt upper limb/lower limb resistance exercises in sitting until fatigued. This process continues (including bed based active-assisted exercise, passive limb mobilisation, functional electrical stimulation) until a minimum total treatment time of 30-minutes has been reached. A treating physiotherapist is also permitted to prescribe a personalised training activity based on a detected functional deficit to be incorporated within the rehabilitation program. All activity (except passive mobilisation or functional electrical stimulation) in the program must aim to be continuous for more than one minute, at an intensity of at least three on the Borg 10-point VAS of perceived exertion and where breathing is deeper than at rest. The treating physiotherapist will use a stopwatch to ensure the treatment session is at least 30-minutes and can provide a walking aid if clinically indicated. Interval training is permitted, however, rest-time cannot exceed the preceding active period. Once rest-time becomes greater than the preceding work-time, the exercise session is considered completed.
The initial starting exercise for each rehabilitation session will be made pragmatically at the discretion of the treating physiotherapist using their own past experience and knowledge base regarding the participant’s current clinical and physiological status. No specific sedation score or assessment screening tool will be used to guide this decision.
All sessions will be conducted by a physiotherapist until at least the fifth postoperative day unless the supervising physiotherapist is confident that a therapy assistant or the participant will undertake the rehabilitation programme exactly as prescribed for the minimum 30-minutes. After the fifth postoperative day, daily treatment with a physiotherapist or therapy assistant will continue until a referral for sub-acute rehabilitation services is made; participant is discharged from hospital; or once a threshold score is met, whichever occurs first. If the patient meets the discharge score prior to the fifth postoperative day, daily treatment will continue until the fifth postoperative day but cease thereafter.
Breathing exercises: The mode, type, and timing of delivery of deep breathing and coughing (DB&C) exercises will be provided as per the control group. Intervention group participants will receive at least three additional physiotherapist-coached DB&C sessions in the first two postoperative days. At least four sessions will be provided in total. Beyond the second day additional coached DB&C can be provided at the discretion of the treating physiotherapist if they consider the patient incapable of performing exercises unsupervised or requires additional respiratory exercises to prevent a postoperative pulmonary complication are indicated. Similar to the control group, no additional prophylactic respiratory interventions apart from the DB&C exercises will be provided.
Intervention code [1] 288512 0
Prevention
Intervention code [2] 291526 0
Rehabilitation
Intervention code [3] 301419 0
Other interventions
Comparator / control treatment
The control group will receive standard-care physiotherapy from the first postoperative day consisting of; education on prevention of complications and need for upright positioning, ambulation, and breathing exercises, a single DB&C coaching session, and no more than 15-minute of supervised ambulation once daily until a threshold score is met to discharge from this service.
A standardised ambulation protocol will be provided as soon as practical after surgery by a physiotherapist. Patients will receive one supervised ambulation session per day until a threshold score is met, or discharge from hospital, whichever occurs first. At every session the participant will be progressed sequentially through the protocol stages aiming to achieve a walking time of at least 10-minutes, but no more than 15-minutes, at an intensity of at least three on the Borg 10-point visual analogue scale (VAS) of perceived exertion, and where breathing is deeper than at rest. The treating physiotherapist will use a stopwatch to ensure the treatment session does not exceed 15-minutes and can provide a walking aid if clinically indicated. If necessary, ambulation sessions can comprise of equal work/rest intervals. Shorter, but not longer, rest times are allowable. The final achieved ambulation stage corresponds to total time walked, including the marching on spot time, and not including rest periods.
Successful ambulation is defined as continuously marching on the spot beside the bed or walking away from the bedside for more than one minute. If participants are unavailable or unable to achieve ambulation for more than one-minute, the assisted ambulation session will be attempted once again on the same day. The reasons for participants being unable to ambulate or not achieving a minimum of 10-minutes will be recorded. If a participant is unable to participate in upright ambulation then no other non-ambulation exercises will be provided that day. An allied health assistant can deliver the ambulation protocol once this is deemed safe to do so by the treating physiotherapist.
Breathing exercises: Participants will receive a single physiotherapy education and coached DB&C session within the first two days following surgery, or once the ward physiotherapist considers a patient cognitively capable of participation.
Physiotherapists will treat patients in upright sitting either in bed or in a chair. The coached DB&C exercises will consist of two sets of 10 slow-flow breaths to maximum inspiratory capacity with two to three inspiratory sniff breath-stacking manoeuvres at the end of each deep breath followed by a three to five seconds breath hold. Each set of 10 breaths are followed by three coughs or forced expiratory technique with an open glottis called a “huff”, with a small firm pillow, or suitable substitute, pressed over on the abdominal incision to support the wound and encourage greater expiratory force. The treating physiotherapist will have the discretion to place hands on the patient’s chest wall during the coaching sessions to provide tactile feedback of performance. Total prescribed dosage of DB&C exercises is 20 breaths and six forced expiratory efforts every hour. No other prophylactic respiratory physiotherapy interventions or reminders to perform the taught DB&C exercises will be provided by the physiotherapist, this includes, but is not limited to, the following; manual or ventilator hyperinflation or recruitment manoeuvres in ventilated patients, manual techniques, positive expiratory pressure devices, or non-invasive ventilation.
Control group
Active

Outcomes
Primary outcome [1] 291157 0
Proportion of participants who develop a Post-operative Pulmonary Complication (PPC) as diagnosed with the following criteria: When four (4) or more of the following criteria are present at any time from midnight to midnight on one postoperative day. 1. Chest radiograph report of collapse/consolidation 2. Raised maximum temperature greater than 38.0 C on more than one consecutive post-operative day 3. Pulse oximetry oxygen saturation (Sp02) less than 90% on room air or whilst on a fraction of inspired oxygen (FiO2) of 0.21 on more than one consecutive post-operative day. 4. Production of yellow, green, or brown sputum different to premorbid status. If no preoperative assessment or documentation assume normal at baseline. 5. Presence of infection on sputum culture report 6. An otherwise unexplained white cell count greater than 11 or less than 3 x10(9th power)/L 7. New abnormal breath sounds on auscultation different to premorbid status. If no preoperative assessment or documentation assume normal at baseline. 8. Physician’s diagnosis of postoperative pulmonary complication OR prescription of an antibiotic specific for respiratory infection.

For this trial, modifications have been made to reduce delays to possible diagnosis of a PPC. An automatic positive threshold for the hypoxemia criterion has been set for ventilated patients if FiO2 is >0.5 or PEEP>7, or where assessors are not able to alter ventilation parameters. Otherwise, FiO2 is reduced to 0.21 and SpO2 observed for 2 minutes. If SpO2 < 90% previous FiO2 immediately reinstated. a positive CXR and/or sputum sample finding can be carried over to the next postoperative day if serial testing was not performed; a CXR can be verbally reported by a blinded senior respiratory physiotherapist or physician, rather than awaiting a radiologist report; and when three factors (out of a possible eight) are present, the blinded site investigator or ward physiotherapist will discuss the option of further diagnostic testing to confirm PPC with the participant’s treating physician. Additionally, patients with three out of eight criterion will be assessed twice daily for any clinical deterioration.
Timepoint [1] 291157 0
Participants are assessed prospectively and daily for a PPC by a blinded assessor until the seventh postoperative day. Thereafter, additional PPC assessments are performed only as clinically suspected until postoperative day 14 when there are signs or symptoms of respiratory system deterioration reported within the medical record.
Secondary outcome [1] 306154 0
Time in days to readiness for hospital discharge
Timepoint [1] 306154 0
Daily measure within the first 14 postoperative days, or discharge from hospital, whichever occurs first and defined by standardised scoring criteria
Secondary outcome [2] 306155 0
Hospital length of stay in days. This is defined as continuous days spent in any type of inpatient hospital service (i.e. acute-care, sub-acute rehabilitation, or time at another hospital) from the day of admission for acute condition to the day of discharge to community. Hospital days will be sub-categorised into acute and sub-acute.
Timepoint [2] 306155 0
Total days in hospital from admission to discharge
Secondary outcome [3] 306156 0
Incidence of prolonged post-operative ileus (PPOI) (%) as diagnosed with the following criteria:
If two or more of the following five criteria are met on or after day 4 postoperatively without prior resolution of “postoperative
ileus”:
a. Nausea or vomiting
b. Inability to tolerate an oral diet over last 24 h
c. Absence of flatus over last 24 h
d. Abdominal distension
e. Radiologic confirmation

(Vather, Trivedi and Bisset, 2013)
Timepoint [3] 306156 0
From the fourth to the 14th postoperative hospital day, or discharge from hospital, whichever occurs first.
Secondary outcome [4] 306157 0
Rate of change in handgrip strength (kg) measured using a handheld dynamometer
Timepoint [4] 306157 0
Four postoperative measures within the first 14-days. Measures will be taken at least two days apart
Secondary outcome [5] 306158 0
Rate of change of the Modified Iowa Level of Assistance (mILOA) score. The mILOA consists of four mobility tasks (supine to sitting on the edge of the bed, sit to stand, walking, and negotiation of one step), which are graded according to the level of assistance required, use of gait aid, and the distance that can be walked. Data will be extracted from the medical and physiotherapy records to score
Timepoint [5] 306158 0
mILOA measured four times, second daily from the first postoperative day and a final score on the day of acute-ward discharge.
Secondary outcome [6] 309078 0
Rate of change in health related quality of life using World Health Organisation Disability Assessment Schedule V2 (WHODAS)
Timepoint [6] 309078 0
Self-rated status in the week prior to surgery, on day of discharge from acute care, and at 90-days following surgery
Secondary outcome [7] 313858 0
Healthcare utilisation measured by collecting: days in ICU and surgical wards, hours of mechanical ventilation, days of supplemental oxygen usage, hours of NIV usage, occasions of service by a physio, occasions of service by a Physio Assistant Extra-ordinary attendance by Medical Officer, days of invasive lines and attachments, use of vasopressors, days of total parental nutrition use, and cross matched with costing and coding data from central health administration.
Timepoint [7] 313858 0
Daily measure from post-operative day 1 to 21 or discharge from hospital, whichever occurs first.
Secondary outcome [8] 347693 0
Referral by the surgical team or other allied health professional for additional acute-ward physiotherapy rehabilitation, sub-acute hospital rehabilitation, or community-based rehabilitation. On receipt of a referral, or by the 14th postoperative day if referral not received, a blinded senior physiotherapist will review the participant’s current medical record and adjudicate for the requirement for rehabilitation services.
Timepoint [8] 347693 0
within the first 14 postoperative days
Secondary outcome [9] 347694 0
Discharge destination from the acute hospital ward (home, rehabilitation facility, nursing home or other hospital) assessed from the medical record indicating the location that the patient was discharged to.
Timepoint [9] 347694 0
On discharge from hospital
Secondary outcome [10] 347695 0
Diagnosis of pneumonia defined as the presence of new CXR infiltrates along with at least two of the following; temperature >38oC, dyspnoea, cough and purulent sputum, altered respiratory auscultation, and white cell count >14,000/ml or leukopenia <3000/ml.
Timepoint [10] 347695 0
Daily screen within the first 14 postoperative hospital days
Secondary outcome [11] 347696 0
Rate in change of the EuroQual QOL score (EQ-5D) measures to be taken directly from the patient.
Timepoint [11] 347696 0
two consecutive measures separated by 48hrs, within the first five postoperative days, and at 90-days following surgery
Secondary outcome [12] 347697 0
Physical capacity using Self-Assessment of Physical Activity Questionnaire from self-rated capacity regarding the week prior to surgery to 90-days following surgery;
Timepoint [12] 347697 0
week prior to surgery to 90-days following surgery
Secondary outcome [13] 347698 0
Time in hours from end of operation to time able to achieve ambulation greater than one minute and 10-minutes
Timepoint [13] 347698 0
Postoperative within hospital stay
Secondary outcome [14] 347699 0
ICU LOS in days
Timepoint [14] 347699 0
during acute hospital stay
Secondary outcome [15] 347700 0
Unplanned ICU admission
Timepoint [15] 347700 0
during acute hospital stay
Secondary outcome [16] 347701 0
All cause mortality
Timepoint [16] 347701 0
in-hospital, 30-days, 90-days, and at 1-year
Secondary outcome [17] 347702 0
Sepsis within the first seven days according to the Sequential Organ Failure Assessment (SOFA) for ICU patients and quick-SOFA for ward patients. This outcome was collected retrospectively on completion of the trial using available data within the existing medical record for each participant.
Timepoint [17] 347702 0
within the first seven days
Secondary outcome [18] 347703 0
Time in days to discharge from physiotherapy as determined daily using the Post-Operative Physiotherapy Discharge Scoring Tool
Timepoint [18] 347703 0
Within acute hospital stay
Secondary outcome [19] 347704 0
Patient reported complications using a standardised semi-structured interview
Timepoint [19] 347704 0
at 90-days following date of first surgical procedure during primary admission.

Eligibility
Key inclusion criteria
Eligible patients will be adults over 18 years having open emergency abdominal surgery. This is defined as time-critical surgery (within 48h of decision to operate) for a condition that is an immediate or intermediate threat to life or organ survival; involving at least one incision greater than, or equal to, 5cm anywhere in the abdomen and through the fascia; for an existing hospital patient or a person admitted through the emergency department and requiring at least an overnight stay.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are as follows: procedures solely involving inguinal hernia repairs, appendectomies, organ transplantation, thoracic, or gynaecological surgery; a PPC diagnosis anytime in the 24h prior to eligibility screening; a pre-existing condition where the patient is unable to stand upright and ambulate for one minute without a seated rest; severe cognitive impairment; unable to understand spoken English without the assistance of an interpreter (as determined by the research assistant, site investigator or ward physiotherapist performing eligibility screening); within seven days of elective abdominal surgery; planned repeat surgery within five days of emergency procedure; approaching imminent death or withdrawal of medical treatment within 48h of their surgical procedure; medical orders not to participate in early active rehabilitation; patients unable to be randomised by the research team within 48h of surgery; enrolment in another clinical trial with similar endpoints; and previous enrolment in ICEAGE.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Surgical ward and ICU admissions and the theatre list from the previous day will be screened daily to identify eligible patients. Once a patient has been deemed eligible the treating ward physiotherapist receives the group allocation by first writing patient details on the next consecutively numbered sealed opaque envelope and then opening the pre-prepared sealed opaque envelope containing a card with the nominated group allocation wrapped in extra paper or aluminium foil.
The allocation sequence will be sealed in an opaque envelope, locked within the primary centres’ research institute, and made unavailable to trial personnel until trial completion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence is determined by a computer generated (http://www.randomizer.org/) blocked random number table (6 blocks of 48) with large blocks to minimise guessing of allocation sequence. An administrative assistant independent of the trial will prepare 288 consecutively numbered (1 to 288) opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
PPC rates previously reported following emergency abdominal surgery are between 30-40%. A 2013 prospective audit (unpublished) of PPC incidence in 50 consecutive patients at the primary participating centre found a rate of 20% (95%CI 10-34%). A 60% relative risk reduction in PPC with timely physiotherapy can be achieved in the elective abdominal surgery population. A total sample size of 262 completed participants (131 per group) is required to detect a reduction in PPC rate by 60% from an anticipated baseline of 20% (20% down to 8%) with an alpha 0.05 and power 80%. This is arbitrarily increased to compensate for a possible 10% drop out/withdrawal rate and uncertainty around baseline incidence and effect size. In total, a sample of 288 participants is required for this trial.
Statistical methods
Imbalances of potential confounding variables between trial groups at recruitment will be assessed. Adjustment covariates will be selected by backward stepwise regression from covariates that are anticipated to affect incidence of PPC. These include: respiratory comorbidity, smoking history, age, gender, length of operation, operation category (upper gastrointestinal, colorectal, urological, other), and ICU admission immediately following the procedure.
Primary outcome
The absolute and relative rates of PPC in the trial groups will be estimated using multivariate robust random effects Poisson generalised linear regression to allow assessment of binary outcomes with or without adjustment for potential confounding variables (incidence rates and rate ratios, 95% confidence intervals, p-values). Treatment centre will be treated as a fixed variable in multi-level models. In addition, the effect of time from the end of surgery/anaesthesia to commencement of symptoms of PPC will be compared using Cox proportional hazards regression with and without covariate adjustment (hazards ratio, 95% confidence intervals, p-values). A Kaplan-Meier graphic representation of this analysis will be performed.
Secondary outcomes
1. Binomial outcomes including rehabilitation referrals, pneumonia, PPOI, unplanned ICU admissions, patient reported complications, and mortality will be analysed using multivariate robust random effects Poisson generalised linear regression.
2. Time-to-event binomial outcomes (e.g. PPC; pneumonia; PPOI; achievement of ambulation goals of 1-minute and 10-minutes; and hospital and ICU LOS, and mortality) will be compared by estimating hazards ratios using Cox proportional hazards regression, with and without covariate adjustment where necessary and graphically illustrated using Kaplan-Meier methods.
3. Measures involving estimation of rate of change over time (QOL and functional capacity) will be analysed using repeated-measures mixed effects linear regression or ordered logistic regression for rank-ordered scale measures.
4. Hospital costs will be compared using mixed effects linear regression. Log transformation of highly skewed cost data will be performed. Depending on the adequacy of the data for purposes of economic analysis, a cost-utility may be conducted.
All outcomes will be analysed on an intention-to-treat basis. An intention-to-protocol sensitivity analysis will be performed by identifying as a separate group participants who received more than 80% of planned protocol sessions as per group allocation. Other planned sensitivity analyses will be made according to age (>65), surgery type (colorectal, upper gastrointestinal, other), preoperative self-reported physical capacity, and gender. Sensitivity of outcome estimates to missing data will be evaluated using multiple imputations. All analyses will be performed using Stata MP2 V14 (StataCorp, College Station, Texas USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2015
Actual
27/06/2015
Date of last participant enrolment
Anticipated
31/10/2018
Actual
30/07/2018
Date of last data collection
Anticipated
30/07/2019
Actual
1/08/2019
Sample size
Target
288
Accrual to date
Final
288
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 1882 0
Launceston General Hospital - Launceston
Recruitment hospital [2] 11065 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 11066 0
Northeast Health Wangaratta - Wangaratta
Recruitment postcode(s) [1] 22868 0
3677 - Wangaratta
Recruitment postcode(s) [2] 22867 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 7660 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 288484 0
Charities/Societies/Foundations
Name [1] 288484 0
Clifford Craig Foundation
Country [1] 288484 0
Australia
Primary sponsor type
Individual
Name
Ianthe Boden
Address
Physiotherapy Department
Launceston General Hospital
PO Box 1963
Launceston, Tasmania, 7250
Country
Australia
Secondary sponsor category [1] 287186 0
None
Name [1] 287186 0
Address [1] 287186 0
Country [1] 287186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290347 0
Human Research Ethics committee (Tasmania) network
Ethics committee address [1] 290347 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, Tasmania, 7001
Ethics committee country [1] 290347 0
Australia
Date submitted for ethics approval [1] 290347 0
Approval date [1] 290347 0
11/06/2014
Ethics approval number [1] 290347 0
H0013666
Ethics committee name [2] 293257 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 293257 0
Monash University
Room 111, Chancellery Building E
24 Sports Walk
Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [2] 293257 0
Australia
Date submitted for ethics approval [2] 293257 0
25/06/2015
Approval date [2] 293257 0
29/06/2015
Ethics approval number [2] 293257 0
CF15/2550 - 2015001039
Ethics committee name [3] 300569 0
Metro South Human Research Ethics Committee
Ethics committee address [3] 300569 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [3] 300569 0
Australia
Date submitted for ethics approval [3] 300569 0
02/11/2017
Approval date [3] 300569 0
25/01/2018
Ethics approval number [3] 300569 0
17/QPAH/786

Summary
Brief summary
Background: Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately-powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard-care alone.
Methods: The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard-care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard-care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15-minutes), or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum two days, and at least 30-minutes of daily supervised early rehabilitation for at least five postoperative days). The primary outcome is respiratory complications during the first seven postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30-days and at one year following surgery.
Discussion: The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, low-harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45230 0
Ms Ianthe Boden
Address 45230 0
Physiotherapy Department Launceston General Hospital PO Box 1963 Launceston, Tasmania 7250
Country 45230 0
Australia
Phone 45230 0
+61 3 6348 7216
Fax 45230 0
Email 45230 0
ianthe.boden@ths.tas.gov.au
Contact person for public queries
Name 45231 0
Ms Ianthe Boden
Address 45231 0
Physiotherapy Department Launceston General Hospital PO Box 1963 Launceston, Tasmania 7250
Country 45231 0
Australia
Phone 45231 0
+61 3 6348 7216
Fax 45231 0
Email 45231 0
ianthe.boden@ths.tas.gov.au
Contact person for scientific queries
Name 45232 0
Ms Ianthe Boden
Address 45232 0
Physiotherapy Department Launceston General Hospital PO Box 1963 Launceston, Tasmania 7250
Country 45232 0
Australia
Phone 45232 0
+61 3 6348 7216
Fax 45232 0
Email 45232 0
ianthe.boden@ths.tas.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the deidentified IPD collected during the trial as specified in the protocol.
When will data be available (start and end dates)?
2 years from date of main result publication with no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor primarily based on the methodological quality of the proposal for data utilisation.
Available for what types of analyses?
to achieve the aims in the approved proposal, including IPD meta-analyses
How or where can data be obtained?
access subject to data sharing agreement and ethical/instutional review board clearance to share deidentified data.


What supporting documents are/will be available?



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery.2018https://dx.doi.org/10.1186/s13017-018-0189-y
N.B. These documents automatically identified may not have been verified by the study sponsor.