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IMT in Hypercapnic Patients With COPD (THYPISK-f)

Primary Purpose

COPD

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IMT
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Hypercapnia, Physiotherapy, Inspiratory Muscle Training

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Copenhagen University Hospital, Hvidovre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMT-feasibility

Arm Description

Single arm intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2016
Last Updated
October 4, 2019
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02914093
Brief Title
IMT in Hypercapnic Patients With COPD
Acronym
THYPISK-f
Official Title
Feasibility of Inspiratory Muscle Training in Patients With Chronic Hypercapnia and Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Hypercapnia, Physiotherapy, Inspiratory Muscle Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT-feasibility
Arm Type
Experimental
Arm Description
Single arm intervention
Intervention Type
Other
Intervention Name(s)
IMT
Intervention Description
Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program
Primary Outcome Measure Information:
Title
Completed training sessions
Description
Feasibility - if 80% of the planned training sessions have been completed
Time Frame
6 weeks
Title
Changes i Pimax
Description
Feasibility - if the maximum inspiratory strength measured in cmH2O improves by an average of 10 %
Time Frame
6 weeks
Title
Experienced discomfort
Description
Feasibility - if the patients do not experience any discomfort or increased dyspnea during and after training
Time Frame
6 weeks and during the training session
Secondary Outcome Measure Information:
Title
Changes in pCO2
Description
Arterial bloodgas analysis at day 1 and day 42 to measure pCO2 in kPa before and after the intervention
Time Frame
6 weeks
Title
6 minutes walking test
Description
6 MWT assess the distance walked over six minutes as a sub-maximal test of aerobic capacity/ endurance
Time Frame
6 weeks
Title
CAT
Description
CAT (COPD Assessment Test), symptom questionnaire, measured in points from 0- 40
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten T Kristensen, PhD
Organizational Affiliation
Copenhagen University Hospital, Hvidovre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ejvind F Hansen, MD
Organizational Affiliation
Pulmonary Sektion, Copenhagen University Hospital, Hvidovre
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital, Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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IMT in Hypercapnic Patients With COPD

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