Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00710463

Enrollment

Registered

2008-07-04

Start date

2003-05-31

Completion date

2007-11-30

Last updated

2008-07-04

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, non invasive ventilation, pulmonary rehabilitation

Brief summary

Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation. This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.

Detailed description

Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality. The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.

Interventions

DEVICEnon invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)

non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of COPD in stages GOLD IV * Receiving optimized medical treatment and long term oxygen treatment, if indicated * Patient's consent to participate in this trial

Exclusion criteria

* Previous treatment with NIPPV * Unwillingness or intolerance to perform NIPPV * Acute exacerbation of COPD at baseline or during pulmonary rehabilitation, * Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training * Poor controlled coexisting psychiatric or unstable cardiac disease, * Inability to perform a six minute walk test * Extreme hypercapnia (pCO2 \> 74 mmHg)

Design outcomes

Primary

Measure	Time frame
six minute walk distance	beginning to end of rehabilitation

Secondary

Measure	Time frame
quality of life	beginning to end of rehabilitation

Countries

Germany

Outcome results

None listed

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