RecruitingACTRN12625000027415

Inspire Beyond ICU: Inspiratory muscle training for Intensive Care patients requiring prolonged mechanical ventilation

Inspire Beyond ICU” - Effect of inspiratory muscle training on quality of life in ICU patients requiring mechanical ventilation: a multicentre randomised trial


Sponsor

University of Canberra

Enrollment

300 participants

Start Date

Aug 5, 2025

Study Type

Interventional

Conditions

Summary

The sickest patients in the intensive care unit (ICU) receive prolonged, invasive mechanical support for their breathing, which may be lifesaving. But after this, it is common for the breathing muscles to be weak, which makes it difficult to get back to normal breathing, with an increased risk of death or poor recovery. We have found that 2 weeks of breathing muscle training, started in the ICU, is safe, improves breathing muscle strength, and may improve quality of life after ICU. This study tests whether 6 weeks of training improves quality of life after ICU in a larger group of up to 300 patients. We do not know whether the longer period of training will result in significantly better outcomes for patients, and the results of this study will help physiotherapists know whether this is a useful approach for future ICU survivors.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Being on a mechanical ventilator in intensive care for a prolonged period can lead to significant weakness in the breathing muscles, which can make it very hard to come off the ventilator and recover fully. Physiotherapists play a key role in helping ICU patients rebuild strength, and one promising approach is inspiratory muscle training (IMT) — exercises that specifically strengthen the muscles used for breathing. The Inspire Beyond ICU study is building on earlier research showing that 2 weeks of breathing muscle training in the ICU is safe and may improve outcomes. This larger study is testing whether extending the training to 6 weeks leads to better quality of life after ICU compared to usual care. Up to 300 patients will be enrolled, and the results will help physiotherapists determine whether longer IMT is worth recommending as a routine part of ICU recovery. You may be eligible if you are an adult who is currently in an ICU on a mechanical ventilator for 5 or more days, are alert enough to follow commands, and are expected to remain in hospital for at least another week. People with certain neurological conditions affecting breathing, significant chest pain from recent surgery or trauma, an undrained pneumothorax, or who have been off the ventilator for more than seven days would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Training will commence as soon as patients meet eligibility criteria (including being stable, awake and alert and consenting to participate in training). This will be either while ventilator-dependent

Training will commence as soon as patients meet eligibility criteria (including being stable, awake and alert and consenting to participate in training). This will be either while ventilator-dependent, or within 7 days of liberation from the ventilator (in the Intensive Care or on the wards). Regardless of when the patient commences training, they will continue for 6 weeks total training. The 6 weeks could be entirely within the Intensive Care Unit (ICU), or in the acute hospital wards, or rehabilitation settings, or home. The intervention is as follows: Within ICU: 5 days per week (Monday - Friday) high-intensity electronic Inspiratory Muscle Training (IMT) using the POWERbreathe KH2 at 30 breaths (5 sets of 6 breaths up to total lung capacity); minimum resistance 50% of Maximal Inspiratory Pressure (MIP). Post ICU discharge: 5 days per week (Monday - Friday) high-intensity IMT coached and supervised by a physiotherapist or allied health assistant using a single-patient-use spring-loaded IMT device (POWERbreathe Medic Plus), 5 sets of 6 breaths per day for 6 weeks from study commencement. The clinician will increase resistance until the patient is just able to open the poppet on the 6th breath of each set. Post-acute hospital discharge: Patients discharged from the hospital < 6 weeks post enrolment (either to home or inpatient rehabilitation) will continue IMT 5 days per week (Monday - Friday) using the POWERbreathe MedicPlus. A subgroup will use a recently developed “smart adaptor” that enables ongoing data collection through an application on the patient’s phone or device. Patients will self-progress resistance so that they are just able to open the poppet on the 6th breath of each set. Weekly follow-up via phone will maximise treatment adherence. Treatment adherence will be recorded via both training diary and/or the “smart adaptor” application. Regardless of which device is used (POWERbreathe KH2 or POWERbreathe MedicPlus), the procedure for patients is the same. Patients will inhale against a specified resistance (as programmed by the treating physiotherapist). They will complete 5 sets of 6 breaths against this resistance, with rests in between as required (including returning to the ventilator if commenced while ventilator-dependent). The patient will breathe into the device via a mouth piece, or if the patient is still ventilator-dependent, or has a tracheostomy in situ, the training device will be connected directly to their artificial airway with a connector as required. Total training time per session is typically less than 10 minutes. Treatment in ICU will be supervised by a physiotherapist or assistant. Training can continue with the spring-loaded MedicPlus training device regardless of location, as this single-patient device stays with the patient. If the patient has returned home, then training can continue independently with weekly follow up via phone via a physiotherapist or assistant, while recording of training activity will occur via the TrackActive Pro App or the smart adaptor app, or with paper-based recording depending on patient’s preference. Smart adaptor training app: A subset of patients will be offered the opportunity to combine the MedicPlus device with a smart adaptor which interfaces with an app on their personal device (e.g. phone or ipad). This app will provide detailed training information and feedback to patients and the research team. This option will only be offered to sites which have funding for smart adaptors (Canberra Hospital, Sunshine Coast University Hospital). The maximum number of participants offered this option is limited by funding of the smart adaptor (as of December 2024, limited to 37). Should other funding options be successful, we may increase sites to include Ipswich Hospital, with a likely total target enrolment of 50 patients using the smart adaptor.


Locations(1)

New Zealand

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ACTRN12625000027415


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