Non-invasive Ventilation and Physical Activity

Not Applicable

Terminated

• Conditions: Neuromuscular Diseases
• Interventions: Device: NIV

• Registration Number: NCT02951572
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Primary Completion: 2017-02
• Study Completion: 2017-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Average daily walking time	Measured after 1 year of NIV	Average daily walking time will be measured by the McRoberts physical activity monitor

Secondary Outcome Measures

Name	Time	Method
Change in functional exercise capacity	After 1 year NIV use	Six minute walking test
Change in quadriceps fatiguability	After 1 year NIV use	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Change in sleep structure and quality of sleep	After 1 year NIV use	Full polysomnography will be used to get insight in sleep improvement
Change in muscle strength	After 1 year NIV use	Quadriceps muscle strength will be measured by magnetic stimulation. MicroFet measurements of wrist flexion/extension and ankle dorsiflexion/plantar flexion Respiratory muscle strength will be measured by maximal inspiratory pressure and sniff nasal inspiratory pressure

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium