Non-invasive Ventilation and Physical Activity

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Neuromuscular Diseases

Treatments: Device: NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT02951572

S54220

Details and patient eligibility

About

As fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation in patients with neuromuscular disorders and thoracic deformations, we hope, by starting non-invasive ventilation and improving these symptoms, to increase their physical activity.

Full description

Patients with neuromuscular disorders and thoracic deformations develop alveolar hypoventilation during their disease progression. At that time, non-invasive ventilation(NIV) can be started as treatment.

Fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation. NIV has the intention to improve these symptoms but no research has been performed whether these improvements also objectively improve physical activity. Further on, no research has been performed on muscle strength and muscle fatigue.

Patients' physical activity, physical capacity and sleep quality will be measured before NIV initiation, after 3 months and 1 year of NIV use.

To start NIV, patients will be admitted to our sleep laboratory for 5 days/4 nights. Polysomnography will be used during NIV titration.

Physical activity will each time be measured by 2 activity monitors during 5 days.

Enrollment: 8 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• restrictive pulmonary function test AND
• symptoms of nocturnal alveolar hypoventilation or
• increased daytime pressure of arterial CO2 (PaCO2) (>45 mmHg) or
• >= 10 mmHg increase in PaCO2 during sleep in comparison to a normal awake supine value

Exclusion criteria

• patients < 16 years
• severe cardiac arrythmias or conduction disturbances
• severe mental disturbances
• amyotrophic lateral sclerosis
• total wheelchair-dependent patients

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patients with RLD initiating NIV

Other group

Description:

Patients with RLD initiating NIV according to Belgian Health guidelines are followed-up before and after NIV initiation

Treatment:

Device: NIV