To investigate the occurrence and burden of morning symptoms in outpatients diagnosed with COPD gold II-IV.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is:
The occurrence and burden of morning symptoms. This will be assessed by
applying the Morning Symptoms questionnaire.
Secondary outcome
• Spirometry measures (VC, FVC, IC, FEV1)
• Lung volumes (FRC, RV and TLC)
• Physical function test (6 minute walking test)
• MRC Dyspnea scale
• St. George Respiratory Questionnaire (SGRQ)
• Clinical COPD questionnaire (CCQ)
• International physical activity questionnaire (IPAQ)
• COPD assesment test (CAT)
• COPD and Asthma Sleep Impact Scale (CASIS)
• Hospital Anxiety and Depression Scale (HADS)
• PROactive Physical Activity in COPD (C-PPAC)
• Absolute number of eosinophils
• Expression of different pro- and anti-inflammatory genes
• Monitoring of the following parameters by using the MoveMonitor (mcRoberts):
o intensity of walking
o mean duration of sitting periods
o mean duration of standing
o nocturnal unrest and
o pattern analysis of sleeping quality.
Background summary
Recent findings suggest that symptoms of patients with COPD vary throughout the
day. Especially in the morning, patients seem to present with an increased
symptom load. However, it is not clear whether this is an common characteristic
of symptomatic patients with COPD, or rather represents a specific phenotype of
COPD patients.
Study objective
To investigate the occurrence and burden of morning symptoms in outpatients
diagnosed with COPD gold II-IV.
Study design
Single center, cross sectional study design.
Study burden and risks
This study includes one visit at the Leiden University Medical Center. At this
visit participants will be subjected to a physical examination, vital signs
will be tested and information regarding medical history and demography,
including ethnicity, will be obtained. Subsequently, pulmonary function tests
will be performed, blood will be drawn, questionnaires will be filled out and a
physical performance test will be conducted. Finally, a MoveMonitor (mcRoberts)
will be provided to the participants, which will measure daily and nightly
activity over a period of one week. After wearing the device for seven
successive days, participants will return the MoveMonitor (mcRoberts) by mail
using provided material by the site. In addition, they will fill out 1
questionnaire and send this back to the site accompanied by the MoveMonitor.
Considering the observational nature of this study, the risks are deemed
negligible.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
COPD stage II-IV diagnosed according to GOLD
Aged between >= 40 years and <= 80 years
Minimum of 10 pack years of smoking
Exclusion criteria
Diagnosis of asthma
Exacerbation of COPD within the past 2 months. See protocol page 9 for details.
History of sensitization to allergens
Significant other lung disease
Comorbidities and severe pain syndromes, which impair exercise capacity
Interfering malignant diseases
Clinical signs of acute heart failure
Serious mental impairment. See protocol page 9 for details
Current participation in a clinical rehabilitation programme
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL51951.058.15 |