Non-invasive Ventilation and Physical Activity

Neuromuscular Diseases Clinical Trial

Official title:

Non-invasive Ventilation and Physical Activity in Patients With Neuromuscular Disorders and Thoracic Wall Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02951572
• Other study ID #: S54220
• Status: Terminated
• Phase: N/A
• Start date: February 2013
• Est. completion date: June 2017

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• NIV

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured before initiation of NIV
Primary	Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured after 3 months of NIV
Primary	Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured after 1 year of NIV
Secondary	Change in functional exercise capacity	Six minute walking test	Before NIV initiation
Secondary	Change in muscle strength	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	Before NIV initiation
Secondary	Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	Before NIV intiation
Secondary	Change in sleep structure and quality of sleep	Full polysomnography will be used to get insight in sleep improvement	Before NIV intiation
Secondary	Change in functional exercise capacity	Six minute walking test	After 3 months of NIV use
Secondary	Change in functional exercise capacity	Six minute walking test	After 1 year NIV use
Secondary	Change in muscle strength	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	After 3 months of NIV use
Secondary	Change in muscle strength	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	After 1 year NIV use
Secondary	Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	After 3 months of NIV use
Secondary	Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	After 1 year NIV use
Secondary	Change in sleep structure and quality of sleep	Full polysomnography will be used to get insight in sleep improvement	After 3 months of NIV use
Secondary	Change in sleep structure and quality of sleep	Full polysomnography will be used to get insight in sleep improvement	After 1 year NIV use