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Effect of high and low level breathing support delivered via a mask during walking in patients with severe kyphoscoliosis

Effect of high and low level pressure support during walking on exercise endurance time in patients with severe kyphoscoliosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000155392
Enrollment
12
Registered
2008-04-02
Start date
2006-08-24
Completion date
Unknown
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

People with severe curvature of the spine (kyphoscoliosis) have a reduced exercise capacity and are often limited by their respiratory system. The aim of this study was to determine the effect of low level and high level breathing support (provided via a mask) during treadmill walking in people with severe curvature of the spine (kyphoscoliosis) compared to sham breathing support and walking unassisted. We hypothesised that only high level breathing support would increase exercise endurance time in people with severe kyphoscoliosis.

Interventions

Each participant performed 4 endurance treadmill tests within one day. One test was performed unassisted, one with continous positive airway pressure (CPAP) of 4cmH2O, one with low level pressure support (PS) of 10cmH2O and one with high level PS of 20cmH2O. Tests were performed in random order. Prior to performing each exercise test, participants rested in the sitting position for 10 minutes. Of the 10 minute rest period, participants breathed unassisted for the first 5 minues. For the second 5

Each participant performed 4 endurance treadmill tests within one day. One test was performed unassisted, one with continous positive airway pressure (CPAP) of 4cmH2O, one with low level pressure support (PS) of 10cmH2O and one with high level PS of 20cmH2O. Tests were performed in random order. Prior to performing each exercise test, participants rested in the sitting position for 10 minutes. Of the 10 minute rest period, participants breathed unassisted for the first 5 minues. For the second 5 minutes of rest, participants breathed on CPAP prior to the CPAP walk test, PS 10 prior to the PS 10 walk test, PS 20 prior to the PS 20 walk test, and a further 5 minute period of breathing unassisted prior to the unassisted walking test. Participants rested for at least 30 minutes while breathing unassisted between each exercise test (and until heart rate, blood pressure, breathlessness, oxygen saturation and exertion had returned to baseline). Participants only received CPAP, PS 10 and PS 20 for the duration of the endurance walk test and 5 minute rest period immediately prior to the walk test as described above.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Severe kyphoscoliosis, on nocturnal domiciliary non-invasive ventilation.

Exclusion criteria

Unstable during past month (admission to hospital, change in medications, change in respiratory symptoms), febrile, uncontrolled hypertension (SBP >160mmHg, DBP > 100mmHg), unstable angina or myocardial infarct in past month, resting HR >120bpm, major psychiatric illness, musculoskeletal or neurological conditions that significantly limit exercise, inability to give informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026