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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
Sponsored by
National Multiple Sclerosis Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
February 11, 2020
Last Updated
August 3, 2020
Sponsor
National Multiple Sclerosis Center
Collaborators
National MS Center Melsbroek
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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.
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
pre- post (3 weeks) (some participants also at 4 weeks)
Secondary Outcome Measure Information:
Title
Change in Pulmonary Dysfunction Index (PDI)
Description
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.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Maximum Phonation time (MFT)
Description
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.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Voice Handicap Index (VHI-10)
Description
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.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Vital Capacity (VC)
Description
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.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Maximum Inspiratory Pressure (MIP)
Description
Maximum inspiratory pressure at which the person inhales against a resistance.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Maximum Expiratory Pressure (MEP)
Description
MEP is the highest pressure that arises during a powerful exhalation against a resistance.
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)
Title
Change in Visual Analogue Scale (VAS) for fatigue
Description
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".
Time Frame
pre- post (3 weeks) (some participants also at 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Noë, Msc
Organizational Affiliation
National MS Center Melsbroek - Speech and Language Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
National MS Center
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://mscenter.be/en
Description
National MS Center Melsbroek

Learn more about this trial

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

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