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Trial record 39 of 5217 for:    neuromuscular disease

Non-invasive Ventilation and Physical Activity

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ClinicalTrials.gov Identifier: NCT02951572
Recruitment Status : Unknown
Verified October 2016 by Dr. Dries Testelmans, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Dries Testelmans, Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Device: NIV Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation and Physical Activity in Patients With Neuromuscular Disorders and Thoracic Wall Disorders
Study Start Date : February 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Average daily walking time [ Time Frame: Measured before initiation of NIV ]
    Average daily walking time will be measured by the McRoberts physical activity monitor

  2. Average daily walking time [ Time Frame: Measured after 3 months of NIV ]
    Average daily walking time will be measured by the McRoberts physical activity monitor

  3. Average daily walking time [ Time Frame: Measured after 1 year of NIV ]
    Average daily walking time will be measured by the McRoberts physical activity monitor


Secondary Outcome Measures :
  1. Change in functional exercise capacity [ Time Frame: Before NIV initiation ]
    Six minute walking test

  2. Change in muscle strength [ Time Frame: Before NIV initiation ]
    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

  3. Change in quadriceps fatiguability [ Time Frame: Before NIV intiation ]
    Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle

  4. Change in sleep structure and quality of sleep [ Time Frame: Before NIV intiation ]
    Full polysomnography will be used to get insight in sleep improvement

  5. Change in functional exercise capacity [ Time Frame: After 3 months of NIV use ]
    Six minute walking test

  6. Change in functional exercise capacity [ Time Frame: After 1 year NIV use ]
    Six minute walking test

  7. Change in muscle strength [ Time Frame: After 3 months of 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

  8. Change in muscle strength [ Time Frame: 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

  9. Change in quadriceps fatiguability [ Time Frame: After 3 months of NIV use ]
    Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle

  10. Change in quadriceps fatiguability [ Time Frame: After 1 year NIV use ]
    Use of magnetic stimulation before and after performing fatigue test of the quadriceps muscle

  11. Change in sleep structure and quality of sleep [ Time Frame: After 3 months of NIV use ]
    Full polysomnography will be used to get insight in sleep improvement

  12. Change in sleep structure and quality of sleep [ Time Frame: After 1 year NIV use ]
    Full polysomnography will be used to get insight in sleep improvement



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951572


Contacts
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Contact: Dries Testelmans, MD, PhD 0032 16 342522 dries.testelmans@uzleuven.be
Contact: Bart Vrijsen, MSc, PT 0032 16 342522 bart.vrijsen@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Bart Vrijsen, MSc, PT         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Dries Testelmans, MD, PhD Universitaire Ziekenhuizen Leuven
Study Director: Bertien Buyse, MD,PhD Universitaire Ziekenhuizen Leuven

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Responsible Party: Dr. Dries Testelmans, MD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02951572     History of Changes
Other Study ID Numbers: S54220
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Dr. Dries Testelmans, Universitaire Ziekenhuizen Leuven:
Noninvasive Ventilation
Physical activity
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases