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Acute Lung Injury - improving functional outcomes in survivors

In Acute Lung Injury survivors, does a program of supervised exercise compared with usual care improve exercise capacity and physical activity?

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000298910
Enrollment
7
Registered
2011-03-21
Start date
2011-09-23
Completion date
2014-06-25
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Acute Lung Injury (ALI) is caused by damage to the blood vessels in the lung as a result of the body’s response to a significant insult. The initial insult can occur within the lung or outside the lung. Acute Lung Injury is characterised by fluid which leaks into the lungs causing severe hypoxaemia. Patients diagnosed with ALI are critically ill and require an admission to intensive care. Preliminary data suggest that patients who survive ALI go on to experience marked limitations to everyday functioning and impaired quality of life (well being). This research aims to evaluate a program of supervised training on the exercise capacity and physical activity of people who survive ALI. We hypothesise that compared with usual care, a supervised high intensity exercise training program will be effective at improving exercise capacity and daily physical activity in ALI survivors

Interventions

Subjects assigned to the intervention group will participate in an 8 week exercise program. The program will comprise two supervised sessions each week, conducted by a registered physiotherapist, and an additional minimum of three unsupervised training sessions per week. Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed

Subjects assigned to the intervention group will participate in an 8 week exercise program. The program will comprise two supervised sessions each week, conducted by a registered physiotherapist, and an additional minimum of three unsupervised training sessions per week. Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed at a walking speed equal to 80% of the average speed achieved during the 6MWT. The cycling program will be prescribed at = 60% of peak power achieved during the CPET. Progression of the intensity and duration of the program’s aerobic components, both supervised and unsupervised, will be titrated to a Borg of 4-6 or a RPE of 14-16 depending on the symptom of exercise limitation. Each supervised session will also comprise a strengthening program targeting the muscle groups identified as weak in the baseline strength testing. Strength training will be calculated based on 70% of a one-repetition maximum (1RM) as found at baseline. Progression of the strength training will involve increasing the weight by 5% of the 1RM each week. The unsupervised training sessions will comprise of a walking program that involves a minimum of 30 minutes exercise for each of the sessions.

Sponsors

Jennifer Mackney
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

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

Inclusion criteria

Patients will be screened from the point of admission to the ICU, on a daily basis by the unit’s dedicated research nurse, to identify suitability for the study. Inclusion criteria will comprise; (i) age > 18 years and, (ii) meet the American-European Consensus Conference criteria for ALI (iii) intubation and ventilation for > 4 days.

Exclusion criteria

Exclusion criteria will comprise the presence of any neurological or musculoskeletal condition likely to adversely affect the ability to mobilise safely or to follow commands. This includes; immobility prior to admission, history of recent major pulmonary resection, documented neurological disease including traumatic brain injury, poorly managed psychiatric disorders, diagnosis or treatment for malignant cancer within preceding 12 months, orthopaedic injuries with mobility restrictions, and inability to understand English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026