To assess in the 4 GOLD stages of COPD:1) Performance based daily physical activity with respect tot the level, types and intensity of daily physical activity;2) Physical predictors for the daily physical activity status;3) Psychosocial predictors…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Daily physical activity (as measured by using pedometers and accelerometers
and a questionnaire).
- Physical predictors (as assessed by lung function (spirometry and body box),
muscle performance test, symptom limited bicycle-ergometer test,
six-minute-walking-test and the Bode-index).
- Psychosocial predictors (as assessed by a large panel of self-administrated
questionnaires and a semi-structured in-depth interview).
- Health related quality of life (as assessed by two disease specific
questionnaires and a generic questionnaire).
Secondary outcome
n.a.
Background summary
Despite the high prevalence of chronic obstructive pulmonary disease (COPD)
there is a striking lack of information about the daily physical activity level
of COPD patients in various stages of their disease (GOLD 1-4). Even less is
known about the predicting factors of daily physical activity. It's not known
if mainly physical factors or psychological factors predict daily physical
activity of COPD patients, and if there are differences between the various
GOLD stages.
Also less is known about its consequences for quality of life.
We hypothesize that daily physical activity level declines gradually with
higher GOLD stages, but declines relatively sharply after reaching GOLD stage
4. Psychosocial factors contribute importantly to the variability of daily
physical activity level in GOLD 1, 2 & 3. In GOLD stage 4 the reciprocal
interaction between physical disability and psychosocial factors is
particularly responsible for the variability in the level of daily physical
activity. Health related quality of life is closely related with daily physical
activity level, much more than with FEV1 (or GOLD stage).
This information is vital for designing successful prevention and management
programs that target the symptom-induced immobility leading to reduced fitness,
depression and social isolation characteristically for COPD.
Study objective
To assess in the 4 GOLD stages of COPD:
1) Performance based daily physical activity with respect tot the level, types
and intensity of daily physical activity;
2) Physical predictors for the daily physical activity status;
3) Psychosocial predictors for daily physical activity status;
4) The relationship between daily physical activity status and health related
quality of life.
Study design
Observational study without a therapeutic intervention.
Study burden and risks
- Totally the study exists of three visits; one at home and within six weeks
two visits will take place at the UMCG hospital.
The first visit will take 2 hours, the second 2,5 hours and the third 1,5 hour.
Between the second and third visit the subjects will ask to wear a pedometer
(for 2 weeks) and a accelerometer (for 1 week).
- The six-minute-walking test and the bicycle ergometer requires strenuous work
output.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
* COPD according to the GOLD criteria (post bronchodilator FEV1/FVC <70%)
* Able to undergo the study procedures
* Able to provide reliable study results (particulary pedometer results)
* Co-morbidity (DM, RA, Crohn, osteoarthrosis etc) is allowed (see exclusion criteria)
Exclusion criteria
* Serious active disease that needs medical treatment (infection, carcinoma, myocard infarction)
* Participation in another study
* COPD exacerbation/ exacerbation treatment within 2 months
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 | NL24745.042.08 |