Back to resultsThe Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BiLevel Noninvasive Ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD III+IV
- Age >18 years
- Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher
Exclusion Criteria:
- Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
- non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
- any disease that precludes exercise training
- inability to understand the patient information
- substance abuse
- oxygen requirement of more than 6l O2/min during exercise
Sites / Locations
- Ruhrlandklinik
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Arm
Intervention Arm
Arm Description
This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance.
This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator.
Outcomes
Primary Outcome Measures
Daily Physical Activity
The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up.
Exercise Capacity
6 Minute Walking Distance will be measured every week during the exercise program.
Secondary Outcome Measures
Quality of Life
Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
Dyspnoea
Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.
Change in Physiological Parameters
Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02100709
Brief Title
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
Official Title
The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Sample size calculation would have been overinflated; re-think study design
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
5. Study Description
Brief Summary
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:
the amount of daily physical activity
Quality of life
The 6-minute walk distance
Time to exacerbation
and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
This arm will perform the pulmonary rehabilitation as specified with no respiratory assistance.
Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
This arm will conduct the pulmonary rehabilitation program with BiLevel Noninvasive Ventilation assistance from a ResMed ventilator.
Intervention Type
Device
Intervention Name(s)
BiLevel Noninvasive Ventilation
Other Intervention Name(s)
NIV, BiPAP, Pressure Support Ventilation, PSV
Intervention Description
Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.
Primary Outcome Measure Information:
Title
Daily Physical Activity
Description
The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up.
Time Frame
3 Months
Title
Exercise Capacity
Description
6 Minute Walking Distance will be measured every week during the exercise program.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
Time Frame
3 Months
Title
Dyspnoea
Description
Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.
Time Frame
6 Weeks
Title
Change in Physiological Parameters
Description
Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.
Time Frame
3 Months
Other Pre-specified Outcome Measures:
Title
Time to pulmonary exacerbation
Description
The average time to exacerbation between groups will be analysed post trial.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD III+IV
Age >18 years
Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher
Exclusion Criteria:
Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
any disease that precludes exercise training
inability to understand the patient information
substance abuse
oxygen requirement of more than 6l O2/min during exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Teschler, Prof. Dr. med.
Organizational Affiliation
Dept. Respiratory & Sleep Medicine - Ruhrlandklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhrlandklinik
City
Tuschen
State/Province
Essen
ZIP/Postal Code
45239
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
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