The Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- National Multiple Sclerosis Center
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change in breathing force
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in breathing force
Time Frame: pre- post (3 weeks) (some participants also at 4 weeks)
Change in Peak Expiratory Flow (PEF)- Maximum flow achieved during a maximum forced exhalation.
Secondary Outcomes
- Change in Visual Analogue Scale (VAS) for fatigue(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Vital Capacity (VC)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Phonation time (MFT)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Voice Handicap Index (VHI-10)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Inspiratory Pressure (MIP)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Maximum Expiratory Pressure (MEP)(pre- post (3 weeks) (some participants also at 4 weeks))
- Change in Pulmonary Dysfunction Index (PDI)(pre- post (3 weeks) (some participants also at 4 weeks))