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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02100709

Enrollment

Registered

2014-04-01

Start date

2014-04-30

Completion date

2016-10-31

Last updated

2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DEVICEBiLevel Noninvasive Ventilation

Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Daily Physical Activity	3 Months	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 Weeks	6 Minute Walking Distance will be measured every week during the exercise program.

Secondary

Measure	Time frame	Description
Quality of Life	3 Months	Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured.
Dyspnoea	6 Weeks	Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale.
Change in Physiological Parameters	3 Months	Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program.

Other

Measure	Time frame	Description
Time to pulmonary exacerbation	12 Months	The average time to exacerbation between groups will be analysed post trial.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026