- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942302
Characterization of Variable MARrcha's Diary Variables as a Useful Measure
Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Elisa Simón
- Phone Number: 910888877
- Email: elisa.simon@bioclever.com
Study Contact Backup
- Name: Ester Salmerón
- Phone Number: 93 2172115
- Email: fucapneumo@gmail.com
Study Locations
-
-
Cataluña
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Barcelona, Cataluña, Spain, 08008
- Recruiting
- FUCAP
-
Contact:
- Elisa Simón
- Phone Number: 910888877
- Email: elisa.simon@bioclever.com
-
Contact:
- Ester Salmerón
- Phone Number: 932172115
- Email: fucapneumo@gmail.com
-
Principal Investigator:
- Francisco Ortega
-
Principal Investigator:
- Cristina Martínez
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Principal Investigator:
- Marc Miravitlles
-
Principal Investigator:
- Francisco García-Río
-
Principal Investigator:
- Pilar Carmen Cebollero
-
Principal Investigator:
- Cristóbal Esteban
-
Principal Investigator:
- Patricia Sobradillo
-
Principal Investigator:
- Ernesto Centeno
-
Principal Investigator:
- María Inés Carrascosa
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Principal Investigator:
- Juan José Soler-Cataluña
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minutes of daily walking
Time Frame: During the 7 days that the device has.
|
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:
|
During the 7 days that the device has.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Date of inclusion in the study
Time Frame: day 9
|
[day-month-year]
|
day 9
|
Age
Time Frame: day 9
|
[date of birth, day-month-year]
|
day 9
|
Sex
Time Frame: day 9
|
[male / female]
|
day 9
|
Size
Time Frame: day 9
|
[cm]
|
day 9
|
Weight
Time Frame: day 9
|
[kg]
|
day 9
|
Body Mass Index
Time Frame: day 9
|
(BMI) [kg / m2]
|
day 9
|
Marital Status
Time Frame: day 9
|
[single / married / separated / divorced / widowed]
|
day 9
|
Family situation
Time Frame: day 9
|
Coexistence situation [only (a) / accompanied)
|
day 9
|
Place of residence
Time Frame: day 9
|
[house / flat / others, specify]
|
day 9
|
Academic training
Time Frame: day 9
|
[without studies, primary, secondary, university studies]
|
day 9
|
Employment status
Time Frame: day 9
|
[self-employed / self-employed / unemployed / retired (a) / household tasks / other, specify]
|
day 9
|
Socioeconomic level
Time Frame: day 9
|
family income 15000€/15000€-25000€/25000€-30000€/>30000€
|
day 9
|
Smoking
Time Frame: day 9
|
[yes / ex]
|
day 9
|
Date
Time Frame: day 9
|
[day-month-year]
|
day 9
|
Description of instruments and measures
Time Frame: day 9
|
Spirometry is a test of lung function (flow and capacity) that evaluates the amount of air through exhalation. The forced spirometry, in particular, is based on making the patient after a maximum inspiration exhale all the air, in the shortest time possible. [forced expiratory volume the first second (FEV1) in milliliters / forced vital capacity (FVC) in milliliters / FEV1 / FVC ratio (FEV1%) |
day 9
|
FEV1
Time Frame: day 9
|
it is a measure of flow and is expressed in milliliters and is the maximum volume exhaled in the first second of a forced expiration.
Its normal value is> 80% of the theoretical value.
|
day 9
|
FVC
Time Frame: day 9
|
it is a measurement of capacity that is expressed in milliliters and is the maximum volume of exhaled air with the maximum possible effort, based on the total volume that the patient expels from maximum inspiration to maximum expiration.
Its normal value is> 80% of the theoretical value.
|
day 9
|
FEV1%
Time Frame: day 9
|
it is indicative of the percentage of the total volume expired during the first second.
Its normal value is> 70-75% of the theoretical value.
|
day 9
|
Phenotype of COPD
Time Frame: day 9
|
[non-exacerbator / mixed COPD-asthma / exacerbation with emphysema /exacerbator with chronic bronchitis]
|
day 9
|
Non-pharmacological treatment
Time Frame: day 9
|
[smoking cessation / rehabilitation program / oxygen therapy / others, specify]
|
day 9
|
Number and scope of treatment of exacerbations suffered in the last year
Time Frame: day 9
|
[ambulatory / hospital]
|
day 9
|
Date of the last moderate-severe exacerbation.
Time Frame: day 9
|
[day-month-year]
|
day 9
|
Scales, questionnaires and indexes
Time Frame: day 9
|
|
day 9
|
Spirometry
Time Frame: day 9
|
|
day 9
|
BODE and BODEX Index (Annex 8)
Time Frame: day 9
|
|
day 9
|
COTE comorbidity index (annex 9)
Time Frame: day 9
|
The COTE index (Divo et al., 2012) describes 10 comorbidities: cancer (lung, esophagus, pancreas and breast) (6 points), other cancers (2 points), anxiety (in women, 6 points), liver cirrhosis (2 points), atrial fibrillation (2 points), diabetes with neuropathy (2 points), pulmonary fibrosis (2 points), congestive heart failure (1 point), gastroduodenal ulcer (1 point) and coronary disease (1 point) (range) 0-25).
A score ≥ 4 increases more than 2 times the expected risk of death.
|
day 9
|
Charlson comorbidity index (InCC) (Annex 10)
Time Frame: day 9
|
The Charlson comorbidity index (Charlson et al., 1987) is a 10-year survival assessment system, depending on the age of the patient being evaluated and the comorbidities of the subject.
In addition to age, it consists of 19 items, which if present, have been found to influence the patient's life expectancy.
Each item has a weight in the index, which can be 1, 2, 3 and 6.
The age ranges are also scored from 0 to 5.
|
day 9
|
HADS questionnaire (Annex 11)
Time Frame: day 9
|
It is a scale that evaluates patients' anxiety and depression status (Zigmond & Snaith, 1983).
One of its main attractions is that it suppresses somatic symptoms so that it can be evaluated independently of the underlying somatic disease.
It consists of 14 items on a Likert scale of 4 points (range 0 - 3) to assess anxiety and depression (7 items for each).
The total score is the sum of the 14 items (range 0 - 42), and for each subscale the score is the sum of the 7 items (range 0 - 21).
It is considered that between 0 and 7 it does not indicate case, between 8 and 10 it would be a doubtful case and the scores superior to 11 are, probably, cases in each one of the subscales.
|
day 9
|
CAT Scale (Annex 12)
Time Frame: day 9
|
The CAT scale (Jones et al., 2009) measures the impact that COPD is having on the well-being and daily life of patients.
It consists of 8 items (cough, sputum, tightness in the chest, shortness of breath climbing slopes / stairs, limitation of activity in the home, confidence to leave home, sleep and energy).
Each item is valued on a scale of 6 points with different formats semantically (from 0 to 5), with a total score from 0 to 40.
A score between 0-10 would be indicative of a low impact of the disease.
|
day 9
|
Modified MRC scale (Annex 13)
Time Frame: day 9
|
The modified MRC scale (Mahler & Wells, 1988) uses a very simple grading system to obtain the degree of dyspnea of the patient.
This scale does not define the sensation of drowning per se, but it shows the degree of alteration that said drowning exerts on a day-to-day basis.
It consists of 5 degrees of physical activity that provokes dyspnea that ranges from 0 (no type of exercise is capable of inducing dyspnea) and 4 (dyspnea prevents the patient from leaving the house or doing activities such as dressing or grooming).
A higher score would be indicative of a greater degree of functional limitation.
|
day 9
|
PROactive questionnaire (Annex 14)
Time Frame: day 9
|
This questionnaire about physical activity is a hybrid tool that combines results perceived by patients (PRO) and given physical activity objectives that come from the accelerometer (Gimeno-Santos et al., 2015).
The version for clinical visit (Clinical visit PROactive PRO) will be used, which gathers the experiences of physical activity of the patients in the last 7 days.
It consists of 12 questions and 2 variables of the accelerometer (14 items in total), with options on a Likert scale of 0 to 4 points, and with a score that ranges between 0 and 56 points.
|
day 9
|
Accelerometer (Annex 15)
Time Frame: from day 2 to 8
|
The accelerometer is a motion sensor that uses a pinzoelectric transducer to detect acceleration movements in any of the 3 space dimensions (antero-posterior, medial-lateral, and longitudinal).
Continuous monitoring of the actual physical activity of each patient will be obtained through a triaxial accelerometer (Dynaport® MoveMonitor) for a week.
The accelerometer will be placed on all participants on the day of the IC signature.
The device will be programmed to start the measurement on the day following V0 (day 2).
The patient will be instructed to carry the device 24 hours a day for the next 7 days (day 2-8).
|
from day 2 to 8
|
Proof of the march (PM6M) (Annex 16)
Time Frame: day 9
|
It is a physical activity test to evaluate the effort capacity, being very simple and easy to perform, with the use of very little equipment (Holland et al., 2014, Singh et al., 2014).
In this case, the maximum distance in meters that the patient travels in 6 minutes will be evaluated.
Due to the learning factor demonstrated in this test, 2 tests will be carried out and the test in which the patient reached the greatest distance will be taken into account in the analysis.
|
day 9
|
Questionnaire on motivation to perform physical activity.
Time Frame: day 9
|
This is the translation into Spanish of the questionnaire developed by Danilack et al, 2014 It consists of 4 domains (motivation, confidence, physical environment and social support) For the general reasons of motivation and trust, the subjects were asked: In general, how motivated are you to walk every day?
And How confident do you feel you can walk every day? with responses on a Likert scale from 1 to 10, where the highest scores reflect greater motivation and confidence.
In addition, motivation and confidence were characterized to evaluate the reasons for walking and the confidence to exercise in different situations, including health reasons, bad weather, low energy, lack of time and fear of injury.
|
day 9
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ferran Morell, Fundacio Catalana de Pneumologia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUC-EPO-2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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