To determine the difference in increase in cycle endurance time after PR using NHF oxygen supplementation in patients during both exercise training and night time compared to patients using a conventional oxygen delivery systems.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the increase in cycle endurance time after
completion of the PR program and 6 months after completion of the PR program.
Secondary outcome
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.
Background summary
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 from desaturation and increase the training intensity during PR.
Indeed, Nasal High Flow (NHF) oxygen delivery systems have shown to improve
endurance cycling time when applied in in laboratory settings. In addition,
the night-time use of NHF oxygen delivery systems have been shown to improve
symptoms and exacerbation frequency in patients with COPD. Continuous use
during night and resting time of this device during and 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.
Study objective
To determine the difference in increase in cycle endurance time after PR using
NHF oxygen supplementation in patients during both exercise training and night
time compared to patients using a conventional oxygen delivery systems.
Study design
This is a prospective, single-blind, randomized controlled trial that will be
conducted during a pulmonary rehabilitation program in CIRO+ Horn.
Intervention
Patients participating in a routine 40-session rehabilitation program at CIRO+
will be randomized to the use of nasal high flow (NHF) oxygen supplementation
during both exercise training and night time or a conventional oxygen delivery
system. Patients will continue to use NHF or the conventional system after PR
at home and will be followed during 6 months.
Study burden and risks
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.
Hornerheide 1 Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1 Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
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
- Lack of motivation for voluntary participation in the present study.
- Not capable to understand the instruction of the NHF oxygen delivery system
- 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64087.100.18 |