COPDPhase 4NCT00291460
Inspiratory Muscle Training in Hypercapnic COPD
A Phase 4 study testing inspiratory muscle training in people with COPD and Respiratory Failure, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
Trial summary
The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Respiratory Failure
- What is being tested?
- inspiratory muscle training
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Mar 2008
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD with FEV1/FVC < 70 %
- age > 18
- stable disease
- able to walk
- carbon dioxide >= 48 mmHg
Who cannot join
- ejection fraction of the heart < 40 %
- active psychiatric disease
- bronchial hyperresponsiveness according to ATS criteria
- pregnancy
- renal insufficiency with a creatinine < 2 mg/dl
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Fachkrankenhaus Kloster Grafschaft
Schmallenberg, 57392
Dominic Dellweg, M.D., +49 2972 ext. 1257, d.dellweg@fkkg.de
Dominic Dellweg, M.D.
About this study
Official title: Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.
Read the detailed description
Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.
During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.
- Conditions
- COPD, Respiratory Failure
- Being tested
- inspiratory muscle training
- Keywords
- COPD, respiratory failure, inspiratory muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
inspiratory muscle strength
inspiratory muscle endurance
walking distance with dyspnea score
Carbon dioxide level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Investigators
- Dominic Dellweg, M.D., Principal investigator, FKKGDieter Koehler, Prof. Dr., Study chair, FKKG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291460
- Sponsor's protocol ID
- FKKG IMT 0106
- Status last verified
- Feb 2006
- First submitted
- 13 Feb 2006
- Last updated
- 21 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD
- ClinicalTrials.gov ID
- NCT00291460
- Acronym / sponsor ID
- FKKG IMT 0106
- Conditions
- COPD, Respiratory Failure
- Keywords
- COPD, respiratory failure, inspiratory muscle training
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Mar 2008
- First posted
- 14 Feb 2006 (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 trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.
Detailed description
Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.
During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD with FEV1/FVC < 70 %
- age > 18
- stable disease
- able to walk
- carbon dioxide >= 48 mmHg
Key exclusion criteria (5 listed)
- ejection fraction of the heart < 40 %
- active psychiatric disease
- bronchial hyperresponsiveness according to ATS criteria
- pregnancy
- renal insufficiency with a creatinine < 2 mg/dl
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 training | Device | – |
Primary outcome
inspiratory muscle strength
inspiratory muscle endurance
walking distance with dyspnea score
Carbon dioxide level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2006.
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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.
Dominic Dellweg, M.D. principal investigator
FKKG
Dieter Koehler, Prof. Dr. study chair
FKKG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing inspiratory muscle training in people with COPD and Respiratory Failure, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
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 5 inclusion and 5 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 21 Aug 2006. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dominic Dellweg, M.D. (+49 2972 791 ext. 1257, d.dellweg@fkkg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inspiratory muscle strength. The study lists 4 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 21 Aug 2006.