Characterization of Variable MARrcha's Diary Variables as a Useful Measure

NCT03942302 | Unknown

• 1 other identifier: FUC-EPO-2018-01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Minutes of daily walking

  For such effects, the level of physical activity will be determined through a unique question, formulated in 5 different ways, which aims to collect the minutes of physical activity or daily walking minutes. The one that best fits the objective of the study will be selected. The questions that will be asked will be: 1. How many minutes do you walk per day, on average? 2. How many minutes do you walk briskly a day, on average? 3. How many minutes do you walk outside the home on average? 4. How many minutes do you spend doing physical activity a day, on average? 5. How many minutes per day do you engage in moderate to intense physical activity, such as brisk walking, cycling, working in the garden, swimming, dancing, etc., on average?

  During the 7 days that the device has.

Secondary Outcomes (34)

• Date of inclusion in the study

  day 9

• Age

  day 9

• Sex

  day 9

• Size

  day 9

• Weight

  day 9

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Ferran Morell: lead

Study Sites (1)

FUCAP

Barcelona, Catalonia, 08008, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ferran Morell

  Fundacio Catalana de Pneumologia

  STUDY DIRECTOR

Central Study Contacts

Elisa Simón

CONTACT

910888877; elisa.simon@bioclever.com

Ester Salmerón

CONTACT

93 2172115; fucapneumo@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 8, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

ES (1)