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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04295616
• Other study ID #: S 501553
• Status: Terminated
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: July 20, 2020

Study information

• Verified date: August 2020
• Source: National Multiple Sclerosis Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	National MS Center	Melsbroek

Sponsors (2)

Lead Sponsor	Collaborator
National Multiple Sclerosis Center	National MS Center Melsbroek

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   National MS Center Melsbroek