The purpose of the study is initial validation and item reduction of the draft questionnaire. This information will be used to improve and further develop the questionnaire into an instrument that will adequately measure physical activity in…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is the inital validation and itemreduction of the
draft questionnaire.
Secondary outcome
not applicable
Background summary
In the next decade Chronic Obstructive Pulmonary Disease (COPD) will affect an
increasing number of European
citizens. Physical inactivity and symptoms during physical activity are a
hallmark of COPD and inactivity itself
contributes to the diseaes progression. The inability to participate in daily
activities is an important consequence of
COPD experiened by patients on a daily basis. Improvement of the ability to
participate in physicial activity with minimal
symptoms is an important patient centred target in the management of COPD.
Despite its importance, currently no
Patient Reported Outcome (PRO) captures physical activity in daily life in a
way that is maximally reflects the
experience of COPD patients.
Study objective
The purpose of the study is initial validation and item reduction of the draft
questionnaire. This information will be used to improve and further develop the
questionnaire into an instrument that will adequately measure physical activity
in patients with COPD.
Study design
The study is made up of three sections:
Period 1, total duration 6 weeks:
All patients start with a number of physical examinations and are asked to
complete questionnaires. They are then randomized to 2 groups. Half of the
participants (Group A) begin with the first two week test period in which they
are asked to complete the daily questionnaire and are asked to wear a
pedometer. This is followed by a rest period of 2 weeks and ends with the
2-week test period in which they only have to wear the pedometer. The other
half (group B) begins with wearing the pedometer for two weeks followed by a
rest period of 2 weeks and ends with the two week test period during which they
are asked to complete the daily questionnaire and have to wear the pedometer.
The two-week periods always begin and end with a visit to the clinic. During
the first visit they undergo physical examinations and complete questionnaires,
on the second, third and fourth visit they are asked to fill in questionnaires
and either receive or return the pedometer.
A small proportion of patients (11) is recruited during an exacerbation
(defined as a hospitalization as a result of worsening of pulmonary symptoms).
These patients start the study after approval has been given by the attending
pulmonologist. The study procedure is identical to that of the stable group
with one exception. They undergo additional physical examinations during visit
4.
Period 2, follow-up after 6 months:
All patients undergo physical examinations and asked to complete questionnaires
during the first visit of this round (visit number 5) including the clinical
visit questionnaire. Consecutively they all have a 1 week period during which
they wear three pedometers (small devices attached to a single elastic belt).
The follow-up round ends with a second visit to the clinic (visit number 6) in
which they are asked to complete questionnaires and return the pedometer.
Period 3, follow-up 12 months after the start of the study:
All patients undergo physical examinations and asked to complete questionnaires
during the first visit (visit number 7) including the clinical visit
questionnaire. Consecutively they all have a 1 week period during which they
wear three pedometers (small devices attached to a single elastic belt). The
follow-up round ends with a second visit to the clinic (visit number 8) in
which they are asked to complete questionnaires and return the pedometer.
Study burden and risks
Central aim of this study is the development of a questionnaire with which the
patient's experience of their physical activity and their limitations in this
can be measured. In order to properly reflect the patients perspective in such
a questionnaire it is of vital importance to include a heterogeneous group of
COPD patients in the design and validation process.
Participation will only take patients' time. They will attend eight visits to
the hospital (four during the first 6-week period and 2 during the follow-up
period), participate in one two week period during which they fill in a short
questionnaire every day and they will partake in 3 two week periods during
which they are asked wear a pedometer.
There is no intervention, therefore no direct benefit for the patient is
expected from participation in this study. Participation in this study poses no
risks, none of the physical examinations are invasive, they are mostly part of
the standard COPD treatment programme .
The results of this study will contribute to future improvement of the
treatment of COPD patients.
Postbus 196
9700 AD Groningen
NL
Postbus 196
9700 AD Groningen
NL
Listed location countries
Age
Inclusion criteria
1. Provision of signed, written, and informed consent prior to conducting any study specific procedures
2. Men or women, >=40 years of age
3. Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
4. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
5. Able to read and write and to use electronic devices and physical activity monitor
Exclusion criteria
1. Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator
2. Respiratory diseases other than COPD (e.g. asthma)
3. COPD exacerbation within 4 weeks prior to Visit 1 (only applicable for patients in the stable group)
4. Cognitive impairment, as judged by the investigator
5. Involvement in the planning and/or conduct of the study
6. Previous randomisation in the present study
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 | NL36466.042.11 |