Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02914093
Status:
TERMINATED
Last Update Posted:
2019-10-08
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMT in Hypercapnic Patients With COPD
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
Official Title:
Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THYPISK-f
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: