Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJuly 4, 2011
November 1, 2010
2.1 years
January 18, 2011
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
inpatient days
from baseline to maximal 60 days after stem cell transplantation
Incidence of pneumonia
from baseline to 30 days after stem cell transplantation
Study Arms (2)
Standard physiotherapy
NO INTERVENTIONStandard Physiotherapy without Inspiratory Muscle Training
Inspiratory muscle training
EXPERIMENTALInspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program
Interventions
Inspiratory Muscle Training with Respifit (5 times per week)
Eligibility Criteria
You may qualify if:
- Patients receiving allogenic stem cell transplantation
- Age 17 - 80 years old
- Informed consent
You may not qualify if:
- Actual pneumonia at the beginning of the trial
- Impaired vision
- Patient is not able to handle "Respifit"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elisabethinen Hospital
Linz, 4020, Austria
Study Officials
- STUDY CHAIR
Hanns Hauser, MD
Elisabethinen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 24, 2011
Study Start
January 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
July 4, 2011
Record last verified: 2010-11