IMT in Hypercapnic Patients With COPD (THYPISK-f)

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.

Study Overview

• Status: Terminated
• Conditions: COPD
• Intervention / Treatment: Other: IMT

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital, Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMT-feasibility; Single arm intervention	Other: IMT; Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Chair: Morten T Kristensen, PhD, Copenhagen University Hospital, Hvidovre; Study Chair: Ejvind F Hansen, MD, Pulmonary Sektion, Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Physiotherapy; Inspiratory Muscle Training; Hypercapnia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: H-16022336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No