Clinical trial NCT04295616: Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).
Official title: The Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: National Multiple Sclerosis Center
Sponsor class: OTHER
Collaborators: name: National MS Center Melsbroek
First posted: 2020-03-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate whether intrapulmonary percussive ventilation (IPV) in combination with active breathing exercises using the flow-based incentive spirometer (Inspirix) has a positive effect on the respiratory values in people with multiple sclerosis (MS).

Detailed description: The primary research question includes "what is the additional effect of intensive IPV treatment in combination with active breathing exercises on respiratory power (Peak Expiratory Flow, PEF) in people with MS?".

In a single-center randomized clinical trial, 96 people with MS-related respiratory problems will be allocated to either the intervention group (IPV + active breathing training) or the control group (active breathing training only). Interventions will be provided by trained speech- and language therapists, in combination with a multidisciplinary rehabilitation programme of 3 weeks. Pre- en posttraining assessment includes measures of respiration, speech and fatigue.

Eligibility criteria: Inclusion Criteria:

* diagnosis MS
* inpatient in the National Multiple Sclerosis Center Melsbroek for at least 3 weeks in the period Jan-Dec 2020
* adequate lip closure
* adequate cognitive functioning (MMSE\>26/30 \& clinical observation)
* Peak Expiratory Flow (PEF) with a cut off score of 80% or lower

Exclusion Criteria:

* IPV or other breathing treatment of more than 1x/week within 3 months prior to study participation
* MS relapse within 3 months prior to study participation
* asthma or Chronic Obstructive Pulmonary Disease (COPD)
* infection of lower respiratory tract within 6 weeks prior to study participation
* infection of upper respiratory tract within 2 weeks prior to study participation

Primary outcomes:
measure: Change in breathing force
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
Secondary outcomes:
measure: Change in Pulmonary Dysfunction Index (PDI)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Maximum Phonation time (MFT)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Voice Handicap Index (VHI-10)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Vital Capacity (VC)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Maximum Inspiratory Pressure (MIP)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Maximum Expiratory Pressure (MEP)
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
measure: Change in Visual Analogue Scale (VAS) for fatigue
timeFrame: pre- post (3 weeks) (some participants also at 4 weeks)
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: National MS Center
Study officials:
affiliation: National MS Center Melsbroek - Speech and Language Therapy
name: Sofie Noë, Msc
role: PRINCIPAL_INVESTIGATOR
References: