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

National Multiple Sclerosis Center

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Behavioral: Active breathing training; Device: Intrapulmonary percussive ventilation (IPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT04295616

S 501553

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

IPV & active breathing training

Experimental group

Description:

Intrapulmonary Percussive Ventilation (IPV) and active breathing exercises, provided by trained speech and language therapists. This training will be performed in combination with a multidisciplinary rehabilitation programme.

Treatment:

Behavioral: Active breathing training

Device: Intrapulmonary percussive ventilation (IPV)

Active breathing training only

Active Comparator group

Description:

Active breathing training provided by trained speech therapists. This training will be performed in combination with a multidisciplinary rehabilitation programme.

Treatment:

Behavioral: Active breathing training