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van CCT (UK)

van CCT (UK)

Daily physical activity in COPD.

- candidate number4243
- NTR NumberNTR1497
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2008
- Secondary IDs3.4.07.036 Asthma Foundation
- Public TitleDaily physical activity in COPD.
- Scientific TitlePhysical and psychological predictors of daily physical activity in COPD.
- hypothesisDaily 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).
- Healt Condition(s) or Problem(s) studiedChronic Obstructive Pulmonary Disease (COPD), Physical activity, Physical exercise, COPD
- Inclusion criteria1. COPD according to the GOLD criteria (post bronchodilator FEV1/FVC<70%)
2. Able to undergo the study procedures
3. Able to provide reliable study results (particularly pedometer results)
4. Written informed consent
5. Co-Morbidity is allowed (see exclusion criteria)
- Exclusion criteria1. Serious active disease that needs medical treatment (for example infection, carcinoma and myocardial infarction)
2. Participation in another study
3. COPD exacerbation/ exacerbation treatment within 2 months
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2008
- planned closingdate1-dec-2011
- Target number of participants120
- InterventionsObservational study without intervention
- Primary outcome- Daily physical activity (measured by a pedometer, an accelerometer and a questionnaire)
- Physical predictors of daily physical activity
a) Lung function
b) Biographical factors
c) Co-morbidity
d) Morphological factors
e) Muscle performance
f) Maximal exercise tolerance
g) BODE-index
h) Sleep quality
- Psychological predictors of daily physical activity
a) Self-efficacy
b) Depression
c) Motivation
d) Social support
e) Illness perception
- Health related quality of life
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Asthma Foundation
- PublicationsN/A
- Brief summaryRationale:
Despite the high prevalence of chronic obstructive pulmonary disease (COPD) there is a striking lack of information about the daily physical activity (DPA) level of COPD patients in various stages of their disease. Even less is known about the predicting factors of DPA. Itís not known if mainly physical or psychological factors predict DPA level of COPD patients and if there are differences between the various GOLD stages. Also little is known about its consequences for quality of life. Such information is vital for designing successful prevention and management programs that target the reduced DPA level leading to reduced fitness, depression and social isolation which are characteristic for COPD.

To assess in the 4 GOLD stages of COPD:
1) performance based DPA status with respect to the level, types and intensity of DPA
2) physical predictors for DPA status
3) psychological predictors for DPA status
4) the relationship between DPA status and health related quality of life

Study design:
observational study without intervention

Study population:
120 representative COPD patients equally distributed over the four GOLD stages.
- Main changes (audit trail)
- RECORD17-okt-2008 - 26-apr-2012

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