Inspiratory Muscle TrainingNCT01281410
Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
A study testing Inspiratory Muscle Training in people with Inspiratory Muscle Training and Stem Cell Transplantation, run by Elisabethinen Hospital at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Inspiratory Muscle Training, Stem Cell Transplantation, Respiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving allogenic stem cell transplantation
- Age 17 - 80 years old
- Informed consent
Who cannot join
- Actual pneumonia at the beginning of the trial
- Impaired vision
- Patient is not able to handle "Respifit"
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Elisabethinen Hospital
Linz, 4020
Hanns Hauser, MD, +437327676 ext. 3340, hanns.hauser@elisabethinen.or.at
Ursula Raschhofer, MSc, +437327676 ext. 3940, ursula.raschhofer@elisabethinen.or.at
About this study
Official title: 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.
- Being tested
- Inspiratory Muscle Training
- Keywords
- respiratory muscles, hematopoetic stem cell transplantation, inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingProcedure or surgery
Inspiratory Muscle Training with Respifit (5 times per week)
inspiratory muscle trainingOther
Inspiratory muscle training with a device named Respifit for patients receiving a hematopoetic stem cell transplantation (till 30 days after their transplantation)
| Study group | Role | What they receive |
|---|---|---|
| Standard physiotherapy | No intervention | Standard Physiotherapy without Inspiratory Muscle Training |
| Inspiratory muscle training | Experimental | Inspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program Receives: Procedure: Inspiratory Muscle Training; Other: inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PI max-value from baseline at 30 days after stem cell transplantation
max strength of the inspiratory muscles
Measured: 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
Measured: baseline and 30 days after stem cell transplantation
Secondary outcomes (2)
inpatient days
Measured: from baseline to maximal 60 days after stem cell transplantation
Incidence of pneumonia
Measured: from baseline to 30 days after stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory Muscle TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabethinen Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hanns Hauser, MD, Study chair, Elisabethinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281410
- Sponsor's protocol ID
- EK 462
- Status last verified
- Nov 2010
- First submitted
- 18 Jan 2011
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01281410
- Acronym / sponsor ID
- EK 462
- Keywords
- respiratory muscles, hematopoetic stem cell transplantation, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Elisabethinen HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physiotherapy | No intervention | –Standard Physiotherapy without Inspiratory Muscle Training |
| Inspiratory muscle training | Experimental | Procedure: Inspiratory Muscle Training, Other: inspiratory muscle trainingInspiratory muscle training with a device named Respifit in addition to the usual physiotherapy program |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving allogenic stem cell transplantation
- Age 17 - 80 years old
- Informed consent
Key exclusion criteria (3 listed)
- Actual pneumonia at the beginning of the trial
- Impaired vision
- Patient is not able to handle "Respifit"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory Muscle Training with Respifit (5 times per week) | Procedure or surgery | Inspiratory muscle training |
| inspiratory muscle trainingInspiratory muscle training with a device named Respifit for patients receiving a hematopoetic stem cell transplantation (till 30 days after their transplantation) | Other | Inspiratory muscle training |
Primary outcome
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
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
2 secondary outcomes
inpatient days
Time frame: from baseline to maximal 60 days after stem cell transplantation
Incidence of pneumonia
Time frame: from baseline to 30 days after stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanns Hauser, MD study chair
Elisabethinen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Inspiratory Muscle Training and Stem Cell Transplantation, run by Elisabethinen Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanns Hauser, MD (+43732 7676 ext. 3340, hanns.hauser@elisabethinen.or.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of PI max-value from baseline at 30 days after stem cell transplantation (time frame: baseline and 30 days after stem cell transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2011.