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

Not Applicable

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Device: Intrapulmonary percussive ventilation (IPV); Behavioral: Active breathing training

• Registration Number: NCT04295616
• Lead Sponsor: National Multiple Sclerosis Center

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.

Study Timeline

• Study Start: 2020-01-13
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPV & active breathing training	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.
IPV & active breathing training	Intrapulmonary percussive ventilation (IPV)	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 only	Active breathing training	Active breathing training provided by trained speech therapists. This training will be performed in combination with a multidisciplinary rehabilitation programme.

Primary Outcome Measures

Name	Time	Method
Change in breathing force	pre- post (3 weeks) (some participants also at 4 weeks)	Change in Peak Expiratory Flow (PEF)- Maximum flow achieved during a maximum forced exhalation.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS) for fatigue	pre- post (3 weeks) (some participants also at 4 weeks)	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".
Change in Vital Capacity (VC)	pre- post (3 weeks) (some participants also at 4 weeks)	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 Phonation time (MFT)	pre- post (3 weeks) (some participants also at 4 weeks)	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)	pre- post (3 weeks) (some participants also at 4 weeks)	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 Maximum Inspiratory Pressure (MIP)	pre- post (3 weeks) (some participants also at 4 weeks)	Maximum inspiratory pressure at which the person inhales against a resistance.
Change in Maximum Expiratory Pressure (MEP)	pre- post (3 weeks) (some participants also at 4 weeks)	MEP is the highest pressure that arises during a powerful exhalation against a resistance.
Change in Pulmonary Dysfunction Index (PDI)	pre- post (3 weeks) (some participants also at 4 weeks)	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.

Trial Locations

Locations (1)

National MS Center; 🇧🇪 Melsbroek, Belgium