IMT in Hypercapnic Patients With COPD

NCT02914093 | Terminated DMC

• 1 other identifier: H-16022336
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Hypercapnia; Physiotherapy; Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (3)

• Completed training sessions

  Feasibility - if 80% of the planned training sessions have been completed

  6 weeks

• Changes i Pimax

  Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %

  6 weeks

• Experienced discomfort

  Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training

  6 weeks and during the training session

Secondary Outcomes (3)

• Changes in pCO2

  6 weeks

• 6 minutes walking test

  6 weeks

• CAT

  6 week

Study Arms (1)

IMT-feasibility

EXPERIMENTAL

Single arm intervention

Other: IMT

Interventions

IMT OTHER

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

IMT-feasibility

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Morten T Kristensen, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Ejvind F Hansen, MD

  Pulmonary Sektion, Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)