The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effect of BiLevel Pressure Support NonInvasive Ventilation on Quality of Life and Exercise Capacity in a COPD Exercise Rehabilitation Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02100709
• Other study ID #: RMD_NIV_COPD_001
• Status: Terminated
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 28, 2017
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• BiLevel Noninvasive Ventilation
Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Locations

Country	Name	City	State
Germany	Ruhrlandklinik	Tuschen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to pulmonary exacerbation	The average time to exacerbation between groups will be analysed post trial.	12 Months
Primary	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.	3 Months
Primary	Exercise Capacity	6 Minute Walking Distance will be measured every week during the exercise program.	6 Weeks
Secondary	Quality of Life	Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.	3 Months
Secondary	Dyspnoea	Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.	6 Weeks
Secondary	Change in Physiological Parameters	Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.	3 Months