Skip to content

ICEAGE trial - Incidence of Complications following Emergency Abdominal surgery: Get Exercising.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000318583
Acronym
ICEAGE
Enrollment
288
Registered
2015-04-08
Start date
2015-06-27
Completion date
2018-07-30
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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: Reh

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.

Sponsors

Ianthe Boden
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026