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

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Intrapulmonary percussive ventilation (IPV)

Active breathing training

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National MS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPV & active breathing training

Active breathing training only

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in breathing force

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

Secondary Outcome Measures

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.

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.

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.

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.

Change in Maximum Inspiratory Pressure (MIP)

Maximum inspiratory pressure at which the person inhales against a resistance.

Change in Maximum Expiratory Pressure (MEP)

MEP is the highest pressure that arises during a powerful exhalation against a resistance.

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".

Full Information

NCT ID

NCT04295616

First Posted

February 11, 2020

Last Updated

August 3, 2020

Sponsor

National Multiple Sclerosis Center

Collaborators

National MS Center Melsbroek

1. Study Identification

Unique Protocol Identification Number

NCT04295616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

July 20, 2020 (Actual)

Study Completion Date

July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Multiple Sclerosis Center

Collaborators

National MS Center Melsbroek

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPV & active breathing training

Arm Type

Experimental

Arm Description

Arm Title

Active breathing training only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Intrapulmonary percussive ventilation (IPV)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Active breathing training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in breathing force

Description

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

Time Frame