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Table 1 TIDieR descriptions of ICEAGE interventions

From: ICEAGE (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

TIDieR criterion

Control

Intervention

Item 1. Brief name: provide the name or a phrase that describes the intervention

Standard care: ‘talk, walk, breathe’

Enhanced physiotherapy care: ‘talk more, exercise more, breathe more’

Item 2 a) Describe any rationale, theory essential to the intervention

After emergency abdominal surgery the most common cause of morbidity and mortality is a postoperative pulmonary complication (PPC).

Postoperative physiotherapy is routinely provided in intensive care units and surgical wards across Australia in an effort to prevent respiratory complications and enhance physical recovery after this major surgery type. Despite ubiquitous provision of this service, the effectiveness of postoperative physiotherapy is unknown.

Treatment components:

‘Talk more’: Repeated education sessions and reminders are allowed to be provided at the discretion of the physiotherapist. It is possible that more education will lead to greater motivation and increased independent performance of breathing and walking exercises.

Item 2 b) Describe goal of the elements essential to the intervention

Treatment components:

‘Talk’: The patient is informed of their risk of postoperative complications due to surgery and prolonged bed rest impairing their lungs and muscles. Education aims to inform, motivate, encourage, and inspire participation in exercises as prescribed. A booklet provides a written record of what was verbally taught.

‘Walk’: Early ambulation away from the bedside after surgery may prevent complications and physical decline after surgery.

‘Breathe’: Breathing and coughing exercises increase lung volumes, prevent postoperative atelectasis, improve gas exchange, clear stagnant secretions, and prevent postoperative pulmonary complications.

‘Exercise more’: The goal is to provide at least double the amount of physical activity daily. Daily physical activity will comprise of both ambulation and functional bed/chair/standing exercises. It is possible that there is a dose-dependent relationship with physical activity after surgery. Additional supervised physical activity early following surgery may hasten physical recovery and prevent complications more effectively.

‘Breathe more’: The goal is to provide at least four times the amount of coached breathing exercises in the first 2 days after surgery. It is possible that more breathing exercises performed early after surgery results in a greater risk reduction in the incidence of PPC.

Item 3. What (materials): describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers.

Participant information materials:

A booklet containing written and pictorial information regarding PPC and their potential prevention with early ambulation and breathing exercises to consolidate the learnt knowledge from verbal education and training.

Intervention providers:

Familiarisation with protocol prior to treating intervention participants.

Badge cards containing the treatment protocol

Template for documentation of treatment delivery

Data entry sheets with further details of protocol

Participant information materials:

As per control

Intervention providers:

As per control

Item 4. What (procedures): describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities

‘Talk’: once off

Patients will have a single face-to-face education session following surgery with their physiotherapist. Patients will be educated on the benefit of walking and breathing exercises to prevent complications and improve recovery after surgery. Participants will be educated on the effect of surgery and bedrest to their lungs and muscles, and the benefit of walking and breathing exercises to prevent complications and improve recovery after surgery. Participants will be encouraged to perform the taught breathing exercises independently every hour during the day until they are walking at least 5 min, four times a day. Participants will also be strongly encouraged by their treating physiotherapist to sit upright, sit out of bed, walk away from their bedside (if safe to do so), or march on the spot beside their bed, as many times as they can during the following days to aid in the prevention of PPCs

Participants will be provided with an education booklet. This booklet contains written and pictorial information about abdominal surgery, expected types of pain management, medical lines and drains, postoperative recovery process, and how to prevent postoperative respiratory complications with early ambulation and self-directed breathing exercises. The breathing exercises are prescribed within with the recommended prescription of reps and sets.

‘Talk more’: at least once, then as often as required

As per the control group. In addition, intervention group participants will receive extra reminders and prompts during the first five postoperative days to perform the prescribed rehabilitation and breathing exercises independently. Pragmatically, the number of additional education sessions and the use of exercise diaries and instruction sheets will be at the discretion of each treating physiotherapist based on their clinical experience and the individual needs of the intervention group participant.

‘Walk’: once daily ambulation only, < 15 min

Initiation—as soon as practical after surgery

Duration—no more than 15 min of total work time

Frequency—once daily until a threshold score is met

Intensity—rating of perceived exertion > 3/10, breathing deeper than at rest.

Type—continuous activity for a minimum 1 min aiming for up to 15 min continuous as patient can tolerate. Allowable to train in intervals with work/rest ratio of 1:1

Mode—ambulation only. At every session the participant will be progressed sequentially through the protocol stages aiming to achieve a walking time of at least 10-min, but no more than 15-min. Successful ambulation is defined as continuously marching on the spot beside the bed or walking away from the bedside for more than 1 min. If a participant is unable to participate in upright ambulation, then no other non-ambulation exercises will be provided that day.

‘Exercise more’: once daily, ambulation and exercises, > 30 min

Initiation—as soon as practical after surgery

Duration—at least 30 min of total work time

Frequency—once daily for at least the first 5 postoperative days and then until a threshold score is met

Intensity—rating of perceived exertion > 3/10, breathing deeper than at rest.

Type—continuous activity for a minimum 1 min aiming for as long as patient can tolerate. Allowable to train in intervals with work/rest ratio of 1:1

Mode—functional exercise programme starting with ambulation as per the control group protocol aiming for at least 15 min and if possible to at least 30 min of walking. If walking time is less than 30 min, non-ambulatory physical activity is continued to be provided until the minimum 30 min of activity time is achieved (not including rest periods). Physical activity is provided in a sequential step-down process starting with the highest activity possible and moving to less intense. These exercises consist of chair- or bed-based progressive low resistance, high repetition, lower and upper limb exercises of three–four sets as prescribed by the treating physiotherapist based on the individual patient’s requirements and functional ability. If a participant is unconscious or acutely unwell, functional electrical stimulation of muscles and/or passive movements of limbs can be used as a physical activity.

‘Breathe’: once off coached session

Participants will receive a single physiotherapy coached deep breathing and coughing (DB&C) session within the first 2 days following surgery, or once the ward physiotherapist considers a patient conscious enough to understand and participate in this session.

Physiotherapists will treat patients in upright sitting either in a 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 3- to 5-s breath hold. Each set of 10 breaths are followed by three coughs, or a 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 to 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. The participants were encouraged to perform these every hour during the day until they were ambulant out of bed at least four times a day, for a minimum of 5 min at a time.

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, incentive spirometers, or non-invasive ventilation.

‘Breathe more’: at least four coached sessions in the first 2 days:

As per the control group. Additionally, 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 they consider the patient requires additional respiratory exercises to prevent a PPC.

Item 5. Who provided: for each category of intervention, provider (for example, psychologist, nursing assistant), describe their expertise, background, and any specific training given

Qualified physiotherapists of varying experience levels at three different hospitals: new graduates, senior physiotherapists, and consultant level physiotherapists.

An allied health assistant can deliver the ambulation protocol once this is deemed safe to do so by the treating physiotherapist.

Qualified physiotherapists of varying experience levels at three different hospitals: new graduates, senior physiotherapists, and consultant level physiotherapists.

All sessions will be conducted by a physiotherapist (not an allied health assistant) until at least the fifth postoperative day unless the supervising physiotherapist is confident that an assistant or participant will undertake the rehabilitation programme exactly as prescribed for the minimum 30 min.

Item 6. How: describe the modes of delivery (such as face to face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group

Face-to-face, individual sessions

Face-to-face, individual sessions

Item 7. Where: describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features

Inpatient hospital wards, patient bedsides at three government-funded, university affiliated, teaching hospitals

Hospitals include a sub-regional secondary referral hospital, a regional primary referral hospital, and a metropolitan primary referral hospital.

Inpatient hospital wards, patient bedsides at three government-funded, university-affiliated, teaching hospitals.

Hospitals include a sub-regional secondary referral hospital, a regional primary referral hospital, and a metropolitan primary referral hospital.

Item 8. When and how much: describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose

See item 4

See item 4

Item 9. Tailoring: if the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how

No tailoring

‘Talk’—Extra education sessions can be provided by physiotherapist as necessary based upon their clinical judgement and the requirements of the patient.

‘Exercise more’—Physiotherapist can incorporate specific functional exercises to target identified individual physical impairments, within the exercise protocol as long as the exercises comply with the goal intensity, duration, and type.

‘Breathe more’—Physiotherapist can provide more DB&C exercise sessions, in addition to the minimum of four coached sessions, in response to clinical judgement of risk and respiratory vulnerability.

Item 10. Modifications: If the intervention was modified during the course of the study, describe the changes (what, why, when, how)

N/A

N/A

Item 11. How well (planned): if intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them

Planned interim analysis of provision of ambulation programme to ensure that in > 80% of patients ambulation duration is no more than 15 min and provided until discharge criteria is met

Planned interim analysis of provision of exercise programme to ensure that in 80% of patients exercise duration is at least 30 min and provided for a minimum of five postoperative days/sessions.

Item 12: How well (actual): if intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned

The trial will be amended or ceased for futility if there are critical failures to recruitment rates, breaches to protocol, or minimal treatment separation between groups.

The trial will be amended or ceased for futility if there are critical failures to recruitment rates, breaches to protocol, or minimal treatment separation between groups.

  1. Abbreviations: PPC postoperative pulmonary complications, DB&C deep breathing and coughing