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

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

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).

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Intrapulmonary percussive ventilation (IPV); Behavioral: Active breathing training

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Melsbroek, Belgium, 1820
    • National MS center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPV & active breathing training; 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); 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.; Behavioral: Active breathing training; 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 Comparator: Active breathing training only; Active breathing training provided by trained speech therapists. This training will be performed in combination with a multidisciplinary rehabilitation programme.	Behavioral: Active breathing training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Dysfunction Index (PDI)	To determine the PDI, the assessor judges the cough force and the ability of the person to count on 1 exhalation. PDI scores vary between 4 and 11 and a higher score indicates increasing respiratory difficulties.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Maximum Phonation time (MFT)	The maximum phonation time (MFT) (in seconds) is measured at a comfortable pitch of the voice. The patient is instructed to breathe in as deeply as possible and to hold / a / as long as possible. MFT is measured three times and the longest value is retained.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Voice Handicap Index (VHI-10)	The Voice Handicap Index (VHI-10) 10-item questionnaire assesses the psychosocial impact on the voice as perceived by the individual. The VHI-10 scores range from 0 to 40, with increasing scores indicating increased psychosocial impact. A score of 11 or higher implies a voice handicap.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Vital Capacity (VC)	Maximum amount of air that is exhaled after a deep inhalation. The person is asked to breathe out as deeply as possible in the mouthpiece after a deep inhalation.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Maximum Inspiratory Pressure (MIP)	Maximum inspiratory pressure at which the person inhales against a resistance.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Maximum Expiratory Pressure (MEP)	MEP is the highest pressure that arises during a powerful exhalation against a resistance.	pre- post (3 weeks) (some participants also at 4 weeks)
Change in Visual Analogue Scale (VAS) for fatigue	This is an assessment instrument consisting of a straight line of 10 cm with two opposite statements at both ends. On the left is the statement "not at all tired" and on the right "extremely tired".	pre- post (3 weeks) (some participants also at 4 weeks)

Collaborators and Investigators

• Sponsor: National Multiple Sclerosis Center
• Collaborators: National MS Center Melsbroek
• Investigators: Principal Investigator: Sofie Noë, Msc, National MS Center Melsbroek - Speech and Language Therapy

Publications and helpful links

Helpful Links

• National MS Center Melsbroek

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): July 20, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: S 501553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No