The Additional Effect of Intrapulmonary Percussive Ventilation (IPV) on Respiration in People With Multiple Sclerosis (MS).

Stopped earlyNot a drug-phase studyMS (type not specified)NCT04295616

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Due to COVID-19 situation IPV is no longer allowed in the center

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Intrapulmonary percussive ventilation (IPV)

Given to everyone in the trial

  • Active breathing training

What it measured

Main measures

  • Change in breathing force

    pre- post (3 weeks) (some participants also at 4 weeks)

Other measures (7)

  • Change in Pulmonary Dysfunction Index (PDI)

    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 Vital Capacity (VC)

    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)

    Physical function
  • Change in Maximum Expiratory Pressure (MEP)

    pre- post (3 weeks) (some participants also at 4 weeks)

    Nerve conduction tests
  • Change in Visual Analogue Scale (VAS) for fatigue

    pre- post (3 weeks) (some participants also at 4 weeks)

    Fatigue

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

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History

    1. Started

      Jan 2020

    2. Main results due

      Jul 2020

    3. Finished

      Jul 2020

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