Clinical trial NCT02951572: Non-invasive Ventilation and Physical Activity
Official title: Non-invasive Ventilation and Physical Activity in Patients With Neuromuscular Disorders and Thoracic Wall Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuromuscular Diseases
Keywords: Noninvasive Ventilation
Physical activity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average daily walking time
timeFrame: Measured before initiation of NIV
measure: Average daily walking time
timeFrame: Measured after 3 months of NIV
measure: Average daily walking time
timeFrame: Measured after 1 year of NIV
Secondary outcomes:
measure: Change in functional exercise capacity
timeFrame: Before NIV initiation
measure: Change in muscle strength
timeFrame: Before NIV initiation
measure: Change in quadriceps fatiguability
timeFrame: Before NIV intiation
measure: Change in sleep structure and quality of sleep
timeFrame: Before NIV intiation
measure: Change in functional exercise capacity
timeFrame: After 3 months of NIV use
measure: Change in functional exercise capacity
timeFrame: After 1 year NIV use
measure: Change in muscle strength
timeFrame: After 3 months of NIV use
measure: Change in muscle strength
timeFrame: After 1 year NIV use
measure: Change in quadriceps fatiguability
timeFrame: After 3 months of NIV use
measure: Change in quadriceps fatiguability
timeFrame: After 1 year NIV use
measure: Change in sleep structure and quality of sleep
timeFrame: After 3 months of NIV use
measure: Change in sleep structure and quality of sleep
timeFrame: After 1 year NIV use
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Dries Testelmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bertien Buyse, MD,PhD
role: STUDY_DIRECTOR
References: