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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)

• Registration Number: NCT00710463
• Lead Sponsor: Deutsche Lungenstiftung e.V.

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.

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2007-09
• Study Completion: 2007-11
• Status Verified: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Last Update Submitted: 2008-07-03
• Study First Posted: 2008-07-04
• Last Update Posted: 2008-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIV treatment group	non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)	patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated, plus newly introduced nocturnal non invasive ventilation.

Primary Outcome Measures

Name	Time	Method
six minute walk distance	beginning to end of rehabilitation

Secondary Outcome Measures

Name	Time	Method
quality of life	beginning to end of rehabilitation

Trial Locations

Locations (1)

Klinikum Berchtesgadener Land; 🇩🇪 Berchtesgaden, Germany