IMT in Hypercapnic Patients With COPD

Not Applicable

Terminated

• Conditions: COPD
• Interventions: Other: IMT

• Registration Number: NCT02914093
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study First Submitted: 2016-07-19
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Primary Completion: 2018-05
• Study Completion: 2018-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMT-feasibility	IMT	Single arm intervention

Primary Outcome Measures

Name	Time	Method
Completed training sessions	6 weeks	Feasibility - if 80% of the planned training sessions have been completed
Changes i Pimax	6 weeks	Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %
Experienced discomfort	6 weeks and during the training session	Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training

Secondary Outcome Measures

Name	Time	Method
6 minutes walking test	6 weeks	6 MWT assess the distance walked over six minutes as a sub-maximal test of aerobic capacity/ endurance
Changes in pCO2	6 weeks	Arterial bloodgas analysis at day 1 and day 42 to measure pCO2 in kPa before and after the intervention
CAT	6 week	CAT (COPD Assessment Test), symptom questionnaire, measured in points from 0- 40

Trial Locations

Locations (1)

Copenhagen University Hospital, Hvidovre; 🇩🇰 Hvidovre, Denmark