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

NCT04295616 | Terminated

• 1 other identifier: S 501553
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in breathing force

  Change in Peak Expiratory Flow (PEF)- Maximum flow achieved during a maximum forced exhalation.

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

Secondary Outcomes (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)

Study Arms (2)

IPV & active breathing training

EXPERIMENTAL

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.

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

Active breathing training only

ACTIVE COMPARATOR

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

Behavioral: Active breathing training

Interventions

Intrapulmonary percussive ventilation (IPV) DEVICE

IPV is a well-tolerated method to pump air jets into the lungs via a mouth mask at frequencies of 100-400 pulses per minute. Each IPV session lasts 15 minutes, whereby the person with MS is firstly administered with a mask for 3 minutes at a high frequency (250 to 400 cycles per minute) and then 12 minutes with a low frequency (75 to 150 cycles per minute). The pressure (1.1 - 1.4 bar) is adjusted so that it is comfortable for every participant, yet there is the maximum possible expansion of the thorax. The sessions are given by speech therapists who are familiar with IPV. The IPV treatment will be provided 5 days a week, during 3 or 4 weeks.

IPV & active breathing training

Active breathing training BEHAVIORAL

The active breathing exercises are based on the flow-based incentive spirometer (Inspirix). The Inspirix is a device consisting of a tube with a ball. A plastic tube is connected to the device with a mouthpiece in which the person with MS will has to breathe in and out. The device is equipped with a control button to build up the resistance (number of cc / sec). The aim is to train the inspiratory and expiratory volume as well as the inspiratory and expiratory exhalation force. These exercises are offered 5 times a week in groups under the supervision of an experienced speech therapist, during 3 or 4 weeks.

Active breathing training only; IPV & active breathing training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Multiple Sclerosis Center: lead
• National MS Center Melsbroek: collaborator

Study Sites (1)

National MS Center

Melsbroek, 1820, Belgium

Location

Related Links

• National MS Center Melsbroek

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sofie Noë, Msc

  National MS Center Melsbroek - Speech and Language Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: March 4, 2020
• Study Start: January 13, 2020
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)