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Pulmonary RehabIlitation with Nasal-high-flow-support in COPD and Effectiveness: The PRINCE study

Pulmonary RehabIlitation with Nasal-high-flow-support in COPD and Effectiveness: The PRINCE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24905
Enrollment
80
Registered
2018-06-26
Start date
2018-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Patients participating in a routine 40-session rehabilitation program at CIRO+ will be randomized to the use of nasal high flow (NHF) oxygen suppletion or a conventional oxygen delivery system.

Sponsors

CIRO+ Horn
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with COPD with hypoxia which at least demand 1 liter oxygen/min during baseline. - Clinical stable on the basis of clinical picture by the chest physician. - Documented desaturation during exercise, which demands at least 2 liters oxygen/min to correct. - Permission for voluntary participation. Patient will be asked during the start of their rehabilitation program and have to sign an informed consent. Patients have the right to withdraw from the study without any negative consequences on their rehabilitation. - Attending the regular rehabilitation program in CIRO+.

Exclusion criteria

Exclusion criteria: - Lack of motivation for voluntary participation in the present study. - Outpatient pulmonary rehabilitation program in a hospital which is part of the CIRO network. - Not capable to perform cycle tests, walk tests and/or endurance training on a cycle ergometer and treadmill because of severe hypoxia/hypercapnia, neuromuscular diseases, joint disorders in hip, leg and/or knee or severe breathlessness.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the increase in cycle endurance time after pulmonary rehabilitation.

Secondary

MeasureTime frame
Secondary study parameters are changes in 6-min walking distance (6MWD), increase in training intensity, oxygen saturation, heart rate, Borg scores for dyspnoea and fatigue, lung function, health status and the number of exacerbations and hospitalizations. Long term outcome measures for the follow-up period are lung function, cycle endurance time, daily symptoms and the number of exacerbations and hospitalizations.

Contacts

Public ContactM. Sillen

Centrum voor Integrale Revalidatie Orgaanfalen, Postbus 4080

mauricesillen@proteion.nl+31 (0)475 587721

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)