COPDIMTCONCT01903772
Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Inspiratory Muscle Training in people with COPD and Inspiratory Muscle Weakness, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD, Inspiratory Muscle Weakness
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Feb 2017
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD
- Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
- Pi,max <60 centimeters of water or <50% of the predicted normal value
Who cannot join
- Major comorbidities preventing successful participation in an 8 week exercise training intervention
- use of non-invasive ventilation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Schön Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83483
About this study
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.
- Conditions
- COPD, Inspiratory Muscle Weakness
- Being tested
- Inspiratory Muscle Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max Receives: Other: Inspiratory Muscle Training |
| Sham Inspiratory Muscle Training | Sham comparator | Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O) Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute walking distance
Measured: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Secondary outcomes (4)
exercise capacity (constant work rate test)
Measured: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
maximal inspiratory pressure (PImax)
Measured: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
inspiratory muscle endurance capacity
Measured: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
dyspnea
measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test
Measured: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2017
- Study completionFeb 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903772
- Sponsor's protocol ID
- IMTCO
- Other IDs
- Schön Klinik BGL
- Acronym
- IMTCO
- Status last verified
- Mar 2017
- First submitted
- 12 Jul 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01903772
- Acronym / sponsor ID
- IMTCO / IMTCO
- Conditions
- COPD, Inspiratory Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Apr 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Jul 2013 (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 additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Other: Inspiratory Muscle TrainingProcedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max |
| Sham Inspiratory Muscle Training | Sham comparator | Other: Inspiratory Muscle TrainingTwice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD
- Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
- Pi,max <60 centimeters of water or <50% of the predicted normal value
Key exclusion criteria (2 listed)
- Major comorbidities preventing successful participation in an 8 week exercise training intervention
- use of non-invasive ventilation
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 | Other | Inspiratory Muscle Training, Sham Inspiratory Muscle Training |
Primary outcome
6-Minute walking distance
Time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
4 secondary outcomes
exercise capacity (constant work rate test)
Time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
maximal inspiratory pressure (PImax)
Time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
inspiratory muscle endurance capacity
Time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
dyspnea
Time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD and Inspiratory Muscle Weakness, run by Schön Klinik Berchtesgadener Land 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute walking distance (time frame: change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program). 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 3 Mar 2017.