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Due to COVID-19 situation IPV is no longer allowed in the center
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| Name | Class |
|---|---|
| National MS Center Melsbroek | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPV & active breathing training | Experimental | 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 Comparator | Active breathing training provided by trained speech therapists. This training will be performed in combination with a multidisciplinary rehabilitation programme. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrapulmonary percussive ventilation (IPV) | Device | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sofie Noë, Msc | National MS Center Melsbroek - Speech and Language Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National MS Center | Melsbroek | 1820 | Belgium |
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| Label | URL |
|---|---|
| National MS Center Melsbroek | View source |
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| Active breathing training | Behavioral | 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. |
|
| 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) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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