IMT in Hypercapnic Patients With COPD

NCT ID: NCT02914093

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-08-31

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMT-feasibility

Single arm intervention

Group Type: EXPERIMENTAL

IMT

Intervention Type: OTHER

Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program

Interventions

IMT

Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linette Marie Kofod

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten T Kristensen, PhD

Role: STUDY_CHAIR

Copenhagen University Hospital, Hvidovre

Ejvind F Hansen, MD

Role: STUDY_CHAIR

Pulmonary Sektion, Copenhagen University Hospital, Hvidovre

Locations

Copenhagen University Hospital, Hvidovre

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

H-16022336

Identifier Type: -

Identifier Source: org_study_id