Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

June 30, 2011 updated by: Elisabethinen Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 30 days after stem cell transplantation
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
baseline and 30 days after stem cell transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elisabethinen Hospital

Investigators

  • Study Chair: Hanns Hauser, MD, Elisabethinen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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