Is the usage of a mobile bilevel device capable of reducing dyspnea during exercise in patients with respiratory insufficiency? – a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013203

Enrollment

Registered

2017-10-20

Start date

2017-11-22

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J44.80 J96.11

Interventions

Group 1: Standardized 6 Minute Walking Trial with the mobile BiPAP device VitaBreath. The frequency of the usage of VitaBreath can be decided by the user. Group 2: Standardized 6 Minute Walking Trial

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: COPD stage IV - definition by GOLD Guideline - preexisting noninvasive ventilation therapy - exclusion of an acute exacerbation - Signed declaration of consent - Patients age >18 years

Exclusion criteria

Exclusion criteria: Patients age <18 years - Mental retardation - Missing declaration of consent - Acute exacerbation of the disease - Unsteady gait

Design outcomes

Primary

Measure	Time frame
Average difference of the Borg dyspnea scale before and after finishing the 6-minute walk test	—

Secondary

Measure	Time frame
- Results of the blood gas analysis after the 6-minute walk by Gyatt - Walking distance - Blood pressure after 6- Minute walk - Vital capacity before and after 6-minute walk	—

Countries

Germany

Contacts

Public ContactSarah Schwarz

Kliniken der Stadt Köln gGmbH

schwarzsa@kliniken-koeln.de0221890718337

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026