Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation

Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01281410
• Other study ID #: EK 462
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2011
• Last updated: June 30, 2011
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2010
• Source: Elisabethinen Hospital
• Contact: Hanns Hauser, MD
• Phone: +43732 7676
• Email: hanns.hauser[@]elisabethinen.or.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inspiratory Muscle Training
• Respiratory Aspiration
• Respiratory Muscle Training
• Stem Cell Transplantation

Intervention

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)

Locations

Country	Name	City	State
Austria	Elisabethinen Hospital	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Elisabethinen Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	inpatient days		from baseline to maximal 60 days after stem cell transplantation	No
Secondary	Incidence of pneumonia		from baseline to 30 days after stem cell transplantation	No