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Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Primary Purpose

Inspiratory Muscle Training, Stem Cell Transplantation, Respiratory Muscle Training

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Inspiratory Muscle Training
inspiratory muscle training
Sponsored by
Elisabethinen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inspiratory Muscle Training focused on measuring respiratory muscles, hematopoetic stem cell transplantation, inspiratory muscle training

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

  • Elisabethinen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard physiotherapy

Inspiratory muscle training

Arm Description

Standard Physiotherapy without Inspiratory Muscle Training

Inspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program

Outcomes

Primary Outcome Measures

Change of PI max-value from baseline at 30 days after stem cell transplantation
max strength of the inspiratory muscles
Change of MVV-value from baseline at 30 days after transplantation
max voluntary volume for Inspiratory muscle endurance

Secondary Outcome Measures

inpatient days
Incidence of pneumonia

Full Information

First Posted
January 18, 2011
Last Updated
June 30, 2011
Sponsor
Elisabethinen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01281410
Brief Title
Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Official Title
Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Elisabethinen Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspiratory Muscle Training, Stem Cell Transplantation, Respiratory Muscle Training
Keywords
respiratory muscles, hematopoetic stem cell transplantation, inspiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard physiotherapy
Arm Type
No Intervention
Arm Description
Standard Physiotherapy without Inspiratory Muscle Training
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
Inspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program
Intervention Type
Procedure
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Inspiratory Muscle Training with Respifit (5 times per week)
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
Inspiratory muscle training with a device named Respifit for patients receiving a hematopoetic stem cell transplantation (till 30 days after their transplantation)
Primary Outcome Measure Information:
Title
Change of PI max-value from baseline at 30 days after stem cell transplantation
Description
max strength of the inspiratory muscles
Time Frame
baseline and 30 days after stem cell transplantation
Title
Change of MVV-value from baseline at 30 days after transplantation
Description
max voluntary volume for Inspiratory muscle endurance
Time Frame
baseline and 30 days after stem cell transplantation
Secondary Outcome Measure Information:
Title
inpatient days
Time Frame
from baseline to maximal 60 days after stem cell transplantation
Title
Incidence of pneumonia
Time Frame
from baseline to 30 days after stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanns Hauser, MD
Phone
+43732 7676
Ext
3340
Email
hanns.hauser@elisabethinen.or.at
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula Raschhofer, MSc
Phone
+437327676
Ext
3940
Email
ursula.raschhofer@elisabethinen.or.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanns Hauser, MD
Organizational Affiliation
Elisabethinen Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Elisabethinen Hospital
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanns Hauser, MD
Phone
+437327676
Ext
3340
Email
hanns.hauser@elisabethinen.or.at
First Name & Middle Initial & Last Name & Degree
Ursula Raschhofer, MSc
Phone
+437327676
Ext
3940
Email
ursula.raschhofer@elisabethinen.or.at
First Name & Middle Initial & Last Name & Degree
Hanns Hauser, MD

12. IPD Sharing Statement

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Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

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