Clinical trial NCT03942302: Characterization of Variable MARrcha's Diary Variables as a Useful Measure
Official title: Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Fundacio Catalana de Pneumologia
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population under study will be constituted by adult patients diagnosed with COPD.

To avoid selection biases, each participating researcher will include in the study the first 10 patients who come to a pulmonology clinic with a clinical diagnosis of COPD and who meet the selection criteria.

Brief summary: Validate a simple clinical tool to evaluate physical activity (the question "How many minutes does it walk per day?" Or equivalent), compared to the rest of the collected physical activity data (PROactive questionnaire and objective physical activity data by means of an accelerometer record) in patients with COPD.

Detailed description: Observational, national and multicenter epidemiological study in adult patients with COPD that will take place in the consultations of specialists in pneumology under conditions of usual clinical practice and that will be developed in two visits per patient.

Eligibility criteria: Inclusion Criteria:

Adult patients, ≥ 40 years.

* Patients diagnosed with COPD according to the GOLD criteria: FEV1 / FVC postbronchodilator \<0.70 in a spirometry performed in the last 12 months.
* Smokers or ex-smokers of ≥10 pack-years.
* Patients with a minimum age in the diagnosis of COPD of at least 6 months.
* Patients who accept their participation in the study and who have given their informed consent (IC) in writing to participate in it.

Exclusion Criteria:

* Patients whose clinical history data are not available.
* Patients unable to understand the study questionnaires.
* Patients with physical limitation (not caused by the respiratory disease, eg disability, orthopedic limitation, etc.) and / or psychic that prevents the proper conduct of the study.
* Patients who present a moderate or severe exacerbation of COPD in the month prior to inclusion.
* Patients with other chronic respiratory diseases other than COPD (such as cystic fibrosis, bronchiectasis of origin other than COPD, neoplasia, pneumonia).
* Patients with serious cardiovascular or neurological diseases.
* Hospital admission for any reason in the month prior to inclusion.

Primary outcomes:
measure: Minutes of daily walking
timeFrame: During the 7 days that the device has.
Secondary outcomes:
measure: Date of inclusion in the study
timeFrame: day 9
measure: Age
timeFrame: day 9
measure: Sex
timeFrame: day 9
measure: Size
timeFrame: day 9
measure: Weight
timeFrame: day 9
measure: Body Mass Index
timeFrame: day 9
measure: Marital Status
timeFrame: day 9
measure: Family situation
timeFrame: day 9
measure: Place of residence
timeFrame: day 9
measure: Academic training
timeFrame: day 9
measure: Employment status
timeFrame: day 9
measure: Socioeconomic level
timeFrame: day 9
measure: Smoking
timeFrame: day 9
measure: Date
timeFrame: day 9
measure: Description of instruments and measures
timeFrame: day 9
measure: FEV1
timeFrame: day 9
measure: FVC
timeFrame: day 9
measure: FEV1%
timeFrame: day 9
measure: Phenotype of COPD
timeFrame: day 9
measure: Non-pharmacological treatment
timeFrame: day 9
measure: Number and scope of treatment of exacerbations suffered in the last year
timeFrame: day 9
measure: Date of the last moderate-severe exacerbation.
timeFrame: day 9
measure: Scales, questionnaires and indexes
timeFrame: day 9
measure: Spirometry
timeFrame: day 9
measure: BODE and BODEX Index (Annex 8)
timeFrame: day 9
measure: COTE comorbidity index (annex 9)
timeFrame: day 9
measure: Charlson comorbidity index (InCC) (Annex 10)
timeFrame: day 9
measure: HADS questionnaire (Annex 11)
timeFrame: day 9
measure: CAT Scale (Annex 12)
timeFrame: day 9
measure: Modified MRC scale (Annex 13)
timeFrame: day 9
measure: PROactive questionnaire (Annex 14)
timeFrame: day 9
measure: Accelerometer (Annex 15)
timeFrame: from day 2 to 8
measure: Proof of the march (PM6M) (Annex 16)
timeFrame: day 9
measure: Questionnaire on motivation to perform physical activity.
timeFrame: day 9
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: FUCAP
state: Cataluña
Study officials:
affiliation: Fundacio Catalana de Pneumologia
name: Ferran Morell
role: STUDY_DIRECTOR
References: