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

Rationale: Exercise-based rehabilitation programs, which for an important part exist of endurance training, are able to partially improve quadriceps muscle strength and endurance, functional exercise performance and health status in patients with chronic obstructive pulmonary disease (COPD). Hypoxia or oxygen desaturation might be the limiting factor to exercise and increase in training intensity during pulmonary rehabilitation (PR). Newer devices that provide treatment with high flow, heated, humidified oxygen might help to prevent patients for desaturation and increase the training intensity during PR. Continuous use of this device after PR at home could potentially help to maintain the beneficial effects of PR. However, the effects of these devices have never been studied during and after PR in patients with COPD.

Objective: To determine the difference in increase in cycle endurance time after PR using NHF oxygen supplementation compared to conventional oxygen delivery systems.



Study design: This is a prospective, single-blind, randomized controlled trial that will be conducted during and after a pulmonary rehabilitation program in CIRO+ Horn.

Study population: Patients with COPD with hypoxia which requires at least 1 liter oxygen/minute in rest and 2 liters oxygen/minute during exercise, with documented desaturation during exercise. Patients will continue to use NHF or the conventional system after PR at home and will be followed during 6 months.

Intervention: 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.

Main study parameters/endpoints: The main study parameter is the increase in cycle endurance time after PR. 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.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will be asked for one extra visit. The following outcomes will be measured after 6 months: lung function, cycle endurance time, daily symptoms, number of exacerbations and hospitalizations. Potential risks are environmental contamination and/or potential cross infection of pathogenic organisms, a dry or bloody nose, skin irritation from the nasal cannula and a fire risk.

Increase in cycle endurance time after pulmonary rehabilitation using NHF oxygen supplementation will be larger compared to conventional oxygen delivery systems.

Baseline-8 weeks (after pulmonary rehabilitation)-6 months after pulmonary rehabilitation

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.