Non-invasive Ventilation and Physical Activity

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

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.

Study Overview

• Status: Terminated
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Device: NIV

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with RLD initiating NIV; Patients with RLD initiating NIV according to Belgian Health guidelines are followed-up before and after NIV initiation	Device: NIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured before initiation of NIV
Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured after 3 months of NIV
Average daily walking time	Average daily walking time will be measured by the McRoberts physical activity monitor	Measured after 1 year of NIV

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional exercise capacity	Six minute walking test	Before NIV initiation
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
Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	Before NIV intiation
Change in sleep structure and quality of sleep	Full polysomnography will be used to get insight in sleep improvement	Before NIV intiation
Change in functional exercise capacity	Six minute walking test	After 3 months of NIV use
Change in functional exercise capacity	Six minute walking test	After 1 year NIV use
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
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
Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	After 3 months of NIV use
Change in quadriceps fatiguability	Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle	After 1 year NIV use
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
Change in sleep structure and quality of sleep	Full polysomnography will be used to get insight in sleep improvement	After 1 year NIV use

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Dries Testelmans, MD, PhD, Universitaire Ziekenhuizen KU Leuven; Study Director: Bertien Buyse, MD,PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Physical activity; Noninvasive Ventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: S54220