The aim of the study is to improve the clinical care and QoL for patients with COPD. We want to do this by means of the evaluation of the efficacy of pulmonary rehabilitation on cognitive function, mood, anxiety, and QoL in people with COPD. In…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between the experimental group and the waiting list control
group on the change of cognitive performance, QoL, mood, and anxiety between
baseline measurement (both groups) and second moment of measurement, either
before treatment (waiting list control group) or after treatment (experimental
group). Cognitive functioning is measured with objective neuropsychological
tests and a self report questionnaire for subjective cognitive functioning.
Mood, anxiety, and QoL are measured with self report questionnaires.
Secondary outcome
not applicable
Background summary
In Chronic Obstructive Pulmonary Disease (COPD) pulmonary function
progressively declines because of airway obstructions as a result of
inflammation and/or lung emphysema. In addition, people with COPD can suffer
from a wide variety of extrapulmonary consequences, impairment in psychosocial
function (e.g., depression, anxiety), and decline in cognitive function. As a
result, people with COPD often report diminished Quality of Life (QoL).
The exact underlying mechanism for cognitive impairment in patients with COPD
is unclear. It is expected that physical as well as psychological factors play
a role. For example a decrease in blood-oxygen saturation, as well as
depression, and anxiety are all associated with COPD and can all impair
cognitive functioning. It has been suggested that cognitive impairment has a
negative influence on treatment adherence, the course of COPD and QoL.
Therefore, a possible treatment of cognitive impairment is necessary. There is
however hardly attention yet for cognitive impairment in the usual care for
patients with COPD and research on treatment of cognitive impairment in COPD is
in its infancy.
Pulmonary rehabilitation has become an evidence-based treatment for people with
COPD. Improving physical endurance and QoL are the main goals of pulmonary
rehabilitation for people with COPD. Improved physical endurance appears to
improve cognitive performance in healthy people and cognitively impaired
people. In addition to physical optimization, pulmonary rehabilitation can
result in decreased depression and/or anxiety which can lead to improved
cognitive function as well. Therefore, it is expected that cognitive
performance in people with COPD will improve after pulmonary rehabilitation.
Study objective
The aim of the study is to improve the clinical care and QoL for patients with
COPD. We want to do this by means of the evaluation of the efficacy of
pulmonary rehabilitation on cognitive function, mood, anxiety, and QoL in
people with COPD. In addition we investigate the relation between physical
functioning, mood, anxiety, Quality of Life and cognitive functioning in people
with COPD, by looking at the predictive value of physical measures, mood,
and/or anxiety on cognitive improvement and by looking at the predictive value
of physical measures, cognitive functioning, mood, and anxiety on the
improvement of Quality of Life.
Study design
Randomized Controlled Trial (RCT) with an experimental and a waiting list
control group. The experimental group is tested at baseline and after treatment
in the last week of the rehabilitation program; the waiting list control group
is tested at baseline and after waiting time, in the first week of the
rehabilitation program. For the experimental group, time between the first and
second measurement can vary from 12 to 29 weeks, with an avarage of 17 weeks.
For the waiting list control group, time between the first and second
measurement can vary from 1 to 17 weeks, with an avarage of 5 weeks. We can
correct for these differences in time interval with statistical analysis
techniques.
Intervention
A multidisciplinary, fulltime Extensive Pulmonary rehabilitation Program with a
duration of 12 weeks, developed at Schoondonck - Centre for pulmonary
Rehabilitation according to the current guidelines on pulmonary rehabilitation.
Study burden and risks
This study is embedded in a 12 week, fulltime pulmonary rehabilitation program
for people with COPD at Schoondonck - Centre for pulmonary Rehabilitation. For
the purpose of this study a NeuroPsychological Assessment (NPA) of
approximately 1 and 30 minutes is added to clinical care as usual. The study
burden is considered low: the extra time for participation is approximately 3
hours in total. There are no known risks associated with a NPA. There are no
direct benefits for participants. Individual results are not reported to
participants.
Postbus 90153
5000 LE Tilburg
NL
Postbus 90153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
diagnosis COPD
reference to Extensive Pulmonary Rehabilitation at Schoondonck
Exclusion criteria
Education level lower than II (=unfinished to the coding system of Verhage (1983)
Reference to the Compact Pulmonary rehabilitation Program at Schoondonck.
Design
Recruitment
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 | NL33713.008.10 |