The aim of this study is to evaluate the effect of a swallowing treatment program on the frequency of COPD exacerbations in the COPD gold II-IV patient groups. The secondary objective is to evaluate the possible improvement in swallowing function.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the number of moderate to severe exacerbations
over a period of 12 months after allocation to treatment or control group. An
exacerbation is defined as moderate if treatment with antibiotics or
corticosteroid is initiated or dosage increase should be given. An exacerbation
is defined as severe if a patient had to be hospitalized because of the
exacerbation or dies.
Secondary outcome
The secondary outcome measure is patient swallowing satisfaction measured by
the VAS (visual analog scale) and the dysphagia disability index. These are
evaluated at baseline and after 12 months
Background summary
Chronic obstructive pulmonary disease (COPD) is characterized by progressive
non-reversible airway constriction. There are four stages of COPD, Gold 1 to 4.
The severity of disease increases by ascending COPD gold level. Exacerbations
or lung attacks in COPD patients cause morbidity, hospitalization and mortality
and greatly affect the quality of life of these patients. Dysphagia increases
the risk of exacerbations in COPD patients. The dysphagia is often not
perceived by patients. Treatment of swallowing disorders and improvement of
swallow coordination improves the quality of swallowing and possibly reduces
the number of exacerbations.
Study objective
The aim of this study is to evaluate the effect of a swallowing treatment
program on the frequency of COPD exacerbations in the COPD gold II-IV patient
groups. The secondary objective is to evaluate the possible improvement in
swallowing function.
Study design
single-blind controlled intervention study
Intervention
swallow therapy
Study burden and risks
There are varying time burdens associated with group allocation. The time
burden will range from two to ten sessions at the rehabilitation center or via
video calls. Additionally home exercise compliance is expected from group 1.
The intervention could theoretical cause choking with possible pneumonia and
exacerbations as a consequence, because participants have not mastered the new
techniques immediately. However, in the therapeutic setting, water will be used
to practice and progressing to other consistencies will only take place when
participants display competent water swallowing techniques. Other side effects
are not known.
maasstadweg 21 maasstadweg 21
Rotterdam 3079DZ
NL
maasstadweg 21 maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• COPD gold 2,3,4 with a Pulmonary Function Testing not older than 12 months
• At least 2 proven moderate or severe COPD exacerbation in the last 2 years
Exclusion criteria
other lungdisease
active exacerbation COPD
reduced learning because of congnitive impairment
recent speech therapy (< 2 years)
other cause for dysphagia
Radiation of the mouth and throat area
Operation of the mouth and throat area
severe language barrier
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 | NL62277.101.18 |