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Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients

Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384981
Enrollment
31
Registered
2011-06-29
Start date
2011-01-31
Completion date
2013-09-30
Last updated
2015-09-04

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary rehabilitation, COPD, non invasive ventilation, NIV, exercise capacity, pulmonary rehabilitation

Brief summary

The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.

Interventions

PROCEDUREpulmonary rehabilitation

Sponsors

ResMed
CollaboratorINDUSTRY
Schön Klinik Berchtesgadener Land
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* confirmed diagnosis of COPD in stages GOLD III/ IV * receiving optimized medical treatment and long term oxygen therapy if needed * patients consent to participate in this trial * no treatment with NIV in the last 4 weeks * treatment with NIV in the last 4 weeks due to an acute exacerbation

Exclusion criteria

* treatment with NIV in the last 4 weeks (except due to an acute exacerbation) * Intolerance to perform NIV * Acute exacerbation at baseline or during PR * Hypercapnia \> pCO2 55mmHg * Inability to perform a 6 minute walking test

Design outcomes

Primary

MeasureTime frameDescription
change in 6 minute walking distanceday 1 and 25change in 6 minute walking distance from baseline to day 25

Secondary

MeasureTime frameDescription
change in quality of life (chronic respiratory questionnaire, CRQ)day 1 and 25change in CRQ-Score from baseline to day 25
change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)day 1 and 25change in SGRQ-Score from baseline to day 25

Countries

Germany

Outcome results

None listed

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