Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Elisabethinen Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Elisabethinen Hospital
ClinicalTrials.gov Identifier:
NCT01281410
First received: January 18, 2011
Last updated: June 30, 2011
Last verified: November 2010
  Purpose

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 Intervention
Inspiratory Muscle Training
Stem Cell Transplantation
Respiratory Muscle Training
Procedure: Inspiratory Muscle Training
Other: inspiratory muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Further study details as provided by Elisabethinen Hospital:

Primary Outcome Measures:
  • Change of PI max-value from baseline at 30 days after stem cell transplantation [ Time Frame: baseline and 30 days after stem cell transplantation ] [ Designated as safety issue: No ]
    max strength of the inspiratory muscles

  • Change of MVV-value from baseline at 30 days after transplantation [ Time Frame: baseline and 30 days after stem cell transplantation ] [ Designated as safety issue: No ]
    max voluntary volume for Inspiratory muscle endurance


Secondary Outcome Measures:
  • inpatient days [ Time Frame: from baseline to maximal 60 days after stem cell transplantation ] [ Designated as safety issue: No ]
  • Incidence of pneumonia [ Time Frame: from baseline to 30 days after stem cell transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: January 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   17 Years to 80 Years
Genders Eligible for Study:   Both
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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ursula Raschhofer,MSc, Elisabethinen Hospital
ClinicalTrials.gov Identifier: NCT01281410     History of Changes
Other Study ID Numbers: EK 462
Study First Received: January 18, 2011
Last Updated: June 30, 2011
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on August 26, 2014