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COPD OUT- Does dosage of physiotherapy management of acute exacerbation of Chronic Obstructive Pulmonary Disease affect OUTcomes?

COPD OUT- Does dosage of physiotherapy management of acute exacerbation of Chronic Obstructive Pulmonary Disease affect OUTcomes? A pilot feasibility trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000448347
Acronym
COPD OUT
Enrollment
80
Registered
2026-04-10
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

None listed

Brief summary

COPD OUT is the first study to see if it is possible to run a clinical study testing two different dosages of physiotherapy treatments that are traditionally provided to adult patients admitted to hospital for treatment of an emphysema or chronic bronchitis flare up. Results of this study are vital to help future researchers design the best study possible to successfully test if physiotherapy is effective in faster resolution of symptoms, improving recovery, and long-term quality of life, in adults admitted to hospital with an acute exacerbation of COPD.

Interventions

Arm 1 participants (Physio-Lite) receive a standard physiotherapy program but with lower intensity. This comprises of patient assessment (assess), education (talk), ambulation only (walk) and encouragement to cough to clear (breathe). The intervention ceases upon the participant’s discharge from physiotherapy or hospital or if any other endpoint is reached. Total duration of an initial session is estimated to be 40 - 55 minutes. Assess: Participants with receive during their first physiotherapy

Arm 1 participants (Physio-Lite) receive a standard physiotherapy program but with lower intensity. This comprises of patient assessment (assess), education (talk), ambulation only (walk) and encouragement to cough to clear (breathe). The intervention ceases upon the participant’s discharge from physiotherapy or hospital or if any other endpoint is reached. Total duration of an initial session is estimated to be 40 - 55 minutes. Assess: Participants with receive during their first physiotherapy session an initial respiratory assessment, full social and functional history assessment including early identification of barriers to discharge (approximately 10 - 15 minutes). Talk: Participants will have a single face-to-face education session during their initial assessment with their physiotherapist (approximately 15 - 20 minutes). During this session, participants will be educated on the role of physiotherapy in managing a flare-up of COPD. Participants will be educated on the benefit of walking, exercise, and coughing to prevent deconditioning and potential further respiratory deterioration. Additionally, participants will receive education about the contributors to breathlessness and be educated how best to manage this. This will include discussion about pursed lip breathing and recovery positions. Participants will be encouraged to sit out of bed, move around the bed space, and walk away from their bedside (if safe to do so) as able outside of their physiotherapy session with appropriate supervision. This information can also be provided ad hoc if requested by the participant during any session, but it will not be prompted. Walk: Mobilisation every second day for up to 10 minutes total. Initiation: As soon as clinically appropriate after admission. Duration: Up to 10 minutes total work time per session. Frequency: Once every second day until discharged from physiotherapy. Intensity: Gentle activity aiming for a moderate level of breathlessness (rated as “slightly breathless” to “moderately breathless” on the Borg scale, approximately 3–4/10). Type: Continuous walking for at least 1 minute, building up to 10 minutes as able. Walking can be performed in intervals with equal rest breaks (1:1 work-to-rest ratio). Mode: Ambulation only. At every session the participant will be progressed sequentially through the protocol stages aiming to achieve a walking time of up to 10-minutes. 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 a participant is unable to participate in upright ambulation then no other non-ambulation exercises will be provided that day. Breathe: Participants will receive a daily respiratory assessment and encouragement to cough to clear their chest (approximately 5 - 10 minutes). No other respiratory physiotherapy interventions will be provided by the physiotherapist, this includes, but is not limited to, the following; manual techniques, positive expiratory pressure devices, incentive spirometers, mechanical insufflation-exsufflation, or non-invasive ventilation. If a participant has a pre-existing airway clearance regime it may be continued, but it will not be encouraged. In both arms, the patient can be considered discharged from physiotherapy when they score greater than or equal to 8 according to the ECOPD DST – Exacerbation of COPD Discharge Screening Tool. Once the patient is discharged from physiotherapy and deemed medically suitable for discharge, they will be reviewed again by a blinded physiotherapist to receive standardised education regarding the benefits of pulmonary rehabilitation and be offered a referral to the program. On the seventh day, if the participant is still in the hospital, a blinded senior physiotherapist will review the participant's progress notes within the medical record and adjudicate the requirement for ward-based or residential rehabilitation services. As all intervention sessions are physiotherapist-supervised, adherence will be defined as successful delivery of the prescribed treatment components. Adherence will be recorded on standardised ward data collection sheets completed by the treating physiotherapist at each session.

Sponsors

Tasmanian Department of Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Eligible participants are adults over the age 18 with a medical diagnosis of COPD meeting at least one of the following criteria: 1) Admitted with a diagnosis of an acute exacerbation of COPD characterised by: a) A sustained worsening of the patient’s symptoms from his or her usual stable state. b) The exacerbation is acute in onset (within 24-48 hours prior to hospital admission). 2) Admitted with a diagnosis of community-acquired pneumonia, type 1 respiratory failure, type 2 respiratory failure, or respiratory virus with a background of COPD.

Exclusion criteria

Exclusion criteria are as follows: 1) Patients admitted to intensive care unit (ICU) or high-dependency unit (HDU); 2) Patients admitted with type 2 respiratory failure requiring non-invasive ventilation; 3) Previously recruited in the trial at a previous admission; 4) Patients with a medical diagnosis of bronchiectasis; 5) Admitted with confirmed SARS-CoV-2 on a positive rapid antigen test or PCR within 48 hours of admission; 6) Patients admitted for palliative management (Goals of Care C2/D); 7) Patients experiencing acute delirium.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 23, 2026