Study Stopped
Recruitment problem
Non-invasive Ventilation and Physical Activity
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 23, 2020
November 1, 2020
4 years
December 9, 2013
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (12)
Change in functional exercise capacity
Before NIV initiation
Change in muscle strength
Before NIV initiation
Change in quadriceps fatiguability
Before NIV intiation
Change in sleep structure and quality of sleep
Before NIV intiation
Change in functional exercise capacity
After 3 months of NIV use
- +7 more secondary outcomes
Study Arms (1)
Patients with RLD initiating NIV
OTHERPatients with RLD initiating NIV according to Belgian Health guidelines are followed-up before and after NIV initiation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients \< 16 years
- severe cardiac arrythmias or conduction disturbances
- severe mental disturbances
- amyotrophic lateral sclerosis
- total wheelchair-dependent patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dries Testelmans, MD, PhD
Universitaire Ziekenhuizen KU Leuven
- STUDY DIRECTOR
Bertien Buyse, MD,PhD
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 9, 2013
First Posted
November 1, 2016
Study Start
February 1, 2013
Primary Completion
February 1, 2017
Study Completion
June 1, 2017
Last Updated
November 23, 2020
Record last verified: 2020-11