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Non-invasive Ventilation and Physical Activity

Primary Purpose

Neuromuscular Diseases

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
NIV
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases focused on measuring Noninvasive Ventilation, Physical activity

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with RLD initiating NIV

Arm Description

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

Outcomes

Primary Outcome Measures

Average daily walking time
Average daily walking time will be measured by the McRoberts physical activity monitor
Average daily walking time
Average daily walking time will be measured by the McRoberts physical activity monitor
Average daily walking time
Average daily walking time will be measured by the McRoberts physical activity monitor

Secondary Outcome Measures

Change in functional exercise capacity
Six minute walking test
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
Change in quadriceps fatiguability
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Change in sleep structure and quality of sleep
Full polysomnography will be used to get insight in sleep improvement
Change in functional exercise capacity
Six minute walking test
Change in functional exercise capacity
Six minute walking test
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
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
Change in quadriceps fatiguability
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Change in quadriceps fatiguability
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Change in sleep structure and quality of sleep
Full polysomnography will be used to get insight in sleep improvement
Change in sleep structure and quality of sleep
Full polysomnography will be used to get insight in sleep improvement

Full Information

First Posted
December 9, 2013
Last Updated
November 19, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02951572
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problem
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases
Keywords
Noninvasive Ventilation, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with RLD initiating NIV
Arm Type
Other
Arm Description
Patients with RLD initiating NIV according to Belgian Health guidelines are followed-up before and after NIV initiation
Intervention Type
Device
Intervention Name(s)
NIV
Primary Outcome Measure Information:
Title
Average daily walking time
Description
Average daily walking time will be measured by the McRoberts physical activity monitor
Time Frame
Measured before initiation of NIV
Title
Average daily walking time
Description
Average daily walking time will be measured by the McRoberts physical activity monitor
Time Frame
Measured after 3 months of NIV
Title
Average daily walking time
Description
Average daily walking time will be measured by the McRoberts physical activity monitor
Time Frame
Measured after 1 year of NIV
Secondary Outcome Measure Information:
Title
Change in functional exercise capacity
Description
Six minute walking test
Time Frame
Before NIV initiation
Title
Change in muscle strength
Description
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
Time Frame
Before NIV initiation
Title
Change in quadriceps fatiguability
Description
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Time Frame
Before NIV intiation
Title
Change in sleep structure and quality of sleep
Description
Full polysomnography will be used to get insight in sleep improvement
Time Frame
Before NIV intiation
Title
Change in functional exercise capacity
Description
Six minute walking test
Time Frame
After 3 months of NIV use
Title
Change in functional exercise capacity
Description
Six minute walking test
Time Frame
After 1 year NIV use
Title
Change in muscle strength
Description
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
Time Frame
After 3 months of NIV use
Title
Change in muscle strength
Description
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
Time Frame
After 1 year NIV use
Title
Change in quadriceps fatiguability
Description
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Time Frame
After 3 months of NIV use
Title
Change in quadriceps fatiguability
Description
Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle
Time Frame
After 1 year NIV use
Title
Change in sleep structure and quality of sleep
Description
Full polysomnography will be used to get insight in sleep improvement
Time Frame
After 3 months of NIV use
Title
Change in sleep structure and quality of sleep
Description
Full polysomnography will be used to get insight in sleep improvement
Time Frame
After 1 year NIV use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertien Buyse, MD,PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Non-invasive Ventilation and Physical Activity

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