Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Study Overview
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Brief Summary
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The study is a monocentric, controlled randomized trial. Its an interventional method study. There is a control and an interventional group. The interventional group is receiving a specific inspiratory muscle training with Respifit (special device for inspiratory muscle training) during the first 30 days after allogenic stem cell transplantation. The investigators want to show that the training group gets stronger inspiratory muscles. The investigators measure the change of PIMAX values and MVV values.

Official Title
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Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Conditions
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Inspiratory Muscle Training, Stem Cell Transplantation, Respiratory Muscle Training

Intervention / Treatment
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* Procedure: Inspiratory Muscle Training
* Other: inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving allogenic stem cell transplantation Age 17 - 80 years old Informed consent Exclusion Criteria: Actual pneumonia at the beginning of the trial Impaired vision Patient is not able to handle Respifit

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard physiotherapy<br>Standard Physiotherapy without Inspiratory Muscle Training | |
| Experimental: Inspiratory muscle training<br>Inspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program | Procedure: Inspiratory Muscle Training<br>* Inspiratory Muscle Training with Respifit (5 times per week)<br>Other: inspiratory muscle training<br>* Inspiratory muscle training with a device named Respifit for patients receiving a hematopoetic stem cell transplantation (till 30 days after their transplantation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of PI max-value from baseline at 30 days after stem cell transplantation | max strength of the inspiratory muscles | baseline and 30 days after stem cell transplantation | 
| Change of MVV-value from baseline at 30 days after transplantation | max voluntary volume for Inspiratory muscle endurance | baseline and 30 days after stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inpatient days |  | from baseline to maximal 60 days after stem cell transplantation | 
| Incidence of pneumonia |  | from baseline to 30 days after stem cell transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory muscles, hematopoetic stem cell transplantation, inspiratory muscle training