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Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01281410
Recruitment Status : Unknown
Verified November 2010 by Elisabethinen Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2011
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
Elisabethinen Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Inspiratory Muscle Training Stem Cell Transplantation Respiratory Muscle Training Procedure: Inspiratory Muscle Training Other: inspiratory muscle training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Study Start Date : January 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

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



Primary Outcome Measures :
  1. Change of PI max-value from baseline at 30 days after stem cell transplantation [ Time Frame: baseline and 30 days after stem cell transplantation ]
    max strength of the inspiratory muscles

  2. Change of MVV-value from baseline at 30 days after transplantation [ Time Frame: baseline and 30 days after stem cell transplantation ]
    max voluntary volume for Inspiratory muscle endurance


Secondary Outcome Measures :
  1. inpatient days [ Time Frame: from baseline to maximal 60 days after stem cell transplantation ]
  2. Incidence of pneumonia [ Time Frame: from baseline to 30 days after stem cell transplantation ]


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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281410


Contacts
Contact: Hanns Hauser, MD +43732 7676 ext 3340 hanns.hauser@elisabethinen.or.at
Contact: Ursula Raschhofer, MSc +437327676 ext 3940 ursula.raschhofer@elisabethinen.or.at

Locations
Austria
Elisabethinen Hospital Recruiting
Linz, Austria, 4020
Contact: Hanns Hauser, MD    +437327676 ext 3340    hanns.hauser@elisabethinen.or.at   
Contact: Ursula Raschhofer, MSc    +437327676 ext 3940    ursula.raschhofer@elisabethinen.or.at   
Principal Investigator: Hanns Hauser, MD         
Sponsors and Collaborators
Elisabethinen Hospital
Investigators
Study Chair: Hanns Hauser, MD Elisabethinen Hospital

Responsible Party: Ursula Raschhofer,MSc, Elisabethinen Hospital
ClinicalTrials.gov Identifier: NCT01281410     History of Changes
Other Study ID Numbers: EK 462
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: November 2010

Keywords provided by Elisabethinen Hospital:
respiratory muscles
hematopoetic stem cell transplantation
inspiratory muscle training

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes