COPDTHYPISK-fNCT02914093
IMT in Hypercapnic Patients With COPD
A study testing IMT in people with COPD, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- IMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Aug 2018
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the diagnosis COPD with FEV1 / FVC <0.70 and FEV1 <50%
- Have elevated pCO2 in stable phase assessed by arterial blood gas with pCO2> 6 kPa
- Have given informed consent
- Can understand written and oral instructions
Who cannot join
- Patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment
- Patients using variable oxygenation rate that may affect the carbon dioxide level.
- Unstable patients and at high risk of exacerbation during the investigation period
- Hospitalized patient with COPD exacerbation during the intervention period
- Patients with an expected need for change of COPD medication or oxygen supply equipment in the study period.
- The participation in the study will be postponed if the patient is in a rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease
The overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.
Read the detailed description
The development of chronic hypercapnia in patients with COPD indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. The inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration.
This study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a Power Breathe device (K3) is possible over a 6 week period in patients with COPD and chronic hypercapnia (pCO2 > 6 kilo pascal).
IMT will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from MIP and if patients do not experience any discomfort or increased dyspnea during training.
The training of the respiratory strength is carried out daily with an electronic handheld device (Power Breathe K3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. Training will take place in the home.
- Conditions
- COPD
- Being tested
- IMT
- Keywords
- Hypercapnia, Physiotherapy, Inspiratory Muscle Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTOther
Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program
| Study group | Role | What they receive |
|---|---|---|
| IMT-feasibility | Experimental | Single arm intervention Receives: Other: IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed training sessions
Feasibility - if 80% of the planned training sessions have been completed
Measured: 6 weeks
Changes i Pimax
Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %
Measured: 6 weeks
Experienced discomfort
Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training
Measured: 6 weeks and during the training session
Secondary outcomes (3)
Changes in pCO2
Arterial bloodgas analysis at day 1 and day 42 to measure pCO2 in kPa before and after the intervention
Measured: 6 weeks
6 minutes walking test
6 MWT assess the distance walked over six minutes as a sub-maximal test of aerobic capacity/ endurance
Measured: 6 weeks
CAT
CAT (COPD Assessment Test), symptom questionnaire, measured in points from 0- 40
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionAug 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linette Marie Kofod, Hvidovre University Hospital
- Investigators
- Morten T Kristensen, PhD, Study chair, Copenhagen University Hospital, HvidovreEjvind F Hansen, MD, Study chair, Pulmonary Sektion, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914093
- Sponsor's protocol ID
- H-16022336
- Acronym
- THYPISK-f
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2016
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02914093
- Acronym / sponsor ID
- THYPISK-f / H-16022336
- Conditions
- COPD
- Keywords
- Hypercapnia, Physiotherapy, Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Sep 2016 (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 overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (IMT) on chronic hypercapnia in patients with severe COPD, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.
Detailed description
The development of chronic hypercapnia in patients with COPD indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. The inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration.
This study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a Power Breathe device (K3) is possible over a 6 week period in patients with COPD and chronic hypercapnia (pCO2 > 6 kilo pascal).
IMT will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from MIP and if patients do not experience any discomfort or increased dyspnea during training.
The training of the respiratory strength is carried out daily with an electronic handheld device (Power Breathe K3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. Training will take place in the home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT-feasibility | Experimental | Other: IMTSingle arm intervention |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have the diagnosis COPD with FEV1 / FVC <0.70 and FEV1 <50%
- Have elevated pCO2 in stable phase assessed by arterial blood gas with pCO2> 6 kPa
- Have given informed consent
- Can understand written and oral instructions
Key exclusion criteria (6 listed)
- Patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment
- Patients using variable oxygenation rate that may affect the carbon dioxide level.
- Unstable patients and at high risk of exacerbation during the investigation period
- Hospitalized patient with COPD exacerbation during the intervention period
- Patients with an expected need for change of COPD medication or oxygen supply equipment in the study period.
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 |
|---|---|---|
| IMTInspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program | Other | IMT-feasibility |
Primary outcome
Completed training sessions
Time frame: 6 weeks
Feasibility - if 80% of the planned training sessions have been completed
Changes i Pimax
Time frame: 6 weeks
Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %
Experienced discomfort
Time frame: 6 weeks and during the training session
Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training
3 secondary outcomes
Changes in pCO2
Time frame: 6 weeks
6 minutes walking test
Time frame: 6 weeks
CAT
Time frame: 6 week
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Morten T Kristensen, PhD study chair
Copenhagen University Hospital, Hvidovre
Ejvind F Hansen, MD study chair
Pulmonary Sektion, Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT in people with COPD, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Oct 2019. 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 Denmark. 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?
The study was stopped early. Results are not available in the source record.
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?
Completed training sessions (time frame: 6 weeks). The study lists 3 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 8 Oct 2019.