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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03942302
• Other study ID #: FUC-EPO-2018-01
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2019
• Source: Fundacio Catalana de Pneumologia
• Contact: Elisa Simón
• Phone: 910888877
• Email: elisa.simon[@]bioclever.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	FUCAP	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Ferran Morell

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: How many minutes do you walk per day, on average?; How many minutes do you walk briskly a day, on average?; How many minutes do you walk outside the home on average?; How many minutes do you spend doing physical activity a day, on average?; 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	Date of inclusion in the study	[day-month-year]	day 9
Secondary	Age	[date of birth, day-month-year]	day 9
Secondary	Sex	[male / female]	day 9
Secondary	Size	[cm]	day 9
Secondary	Weight	[kg]	day 9
Secondary	Body Mass Index	(BMI) [kg / m2]	day 9
Secondary	Marital Status	[single / married / separated / divorced / widowed]	day 9
Secondary	Family situation	Coexistence situation [only (a) / accompanied); Has children? [if not]; If yes, how many children? [and ages for each child]; Does any child live in the family home? [if not]; Number of children in the family home [ages of these children]; Do you have grandchildren? [if not]; If yes, how many grandchildren? [and ages for each grandchild]; Care for your grandchildren on a regular basis? [if not]; Age of each grandchild in care; Frequency with which she takes care of grandchildren [times / week]; Do you have dog / s? [if not. If yes, specify how many]	day 9
Secondary	Place of residence	[house / flat / others, specify]	day 9
Secondary	Academic training	[without studies, primary, secondary, university studies]	day 9
Secondary	Employment status	[self-employed / self-employed / unemployed / retired (a) / household tasks / other, specify]	day 9
Secondary	Socioeconomic level	family income 15000€/15000€-25000€/25000€-30000€/>30000€	day 9
Secondary	Smoking	[yes / ex]; If yes, how many cigarettes / day now? How many packages / year? How many years of current smoking?; In the case of an ex-smoker, how many cigarettes / day did he smoke? How many packages / year did he smoke? How many years of previous smoking? How many years / months without smoking until the start of the study?	day 9
Secondary	Date	[day-month-year]	day 9
Secondary	Description of instruments and measures	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
Secondary	FEV1	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
Secondary	FVC	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
Secondary	FEV1%	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
Secondary	Phenotype of COPD	[non-exacerbator / mixed COPD-asthma / exacerbation with emphysema /exacerbator with chronic bronchitis]	day 9
Secondary	Non-pharmacological treatment	[smoking cessation / rehabilitation program / oxygen therapy / others, specify]	day 9
Secondary	Number and scope of treatment of exacerbations suffered in the last year	[ambulatory / hospital]	day 9
Secondary	Date of the last moderate-severe exacerbation.	[day-month-year]	day 9
Secondary	Scales, questionnaires and indexes	IMC; FEV1% Dyspnea (from the modified MRC scale); Distance collected in the 6MW [meters]; Serious exacerbations in the last 12 months (only visits to hospital emergencies or admissions are included) [number of exacerbations]; Determination of the prognostic severity according to BODEX data [three levels: I (mild of 0-2 points), II (moderate, 3-4 points), III (severe, =5 points)].; COTE comorbidity index, calculated according to 10 comorbidities to be assessed with variable scores, between 1 and 6 points [see Annex 9 for the complete list of comorbidities to be analyzed]	day 9
Secondary	Spirometry	FEV1: is a measure of flow and is expressed in milliliters and is the maximum volume expired in the first second of a forced expiration. Its normal value is> 80% of the theoretical value.; FVC: is a measure 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.; Ratio FEV1 / FVC x 100 (FEV1%): it is indicative of the percentage of the total expired volume during the first second. Its normal value is> 70-75% of the theoretical value.	day 9
Secondary	BODE and BODEX Index (Annex 8)	The BODE index integrates the BMI, the FEV1, the degree of dyspnea (through the data of the modified MRC scale) and the exercise capacity evaluated by means of a 6-minute walk test. The scores of each variable range from 0 to 3 (range 0-10). An increase in one point of the BODE index is associated with a 34% increase in mortality from all causes and 62% in mortality from respiratory causes.; The BODEX index takes into account the number of severe exacerbations (visits to hospital emergencies and admissions) instead of the walking test. The scores for each variable range from 0 to 3 (range 0-9). If the BODEx index is = 5 points, the exercise test will be taken into account to determine the level of severity. Three levels of prognostic severity of COPD will be established: I (mild of 0-2 points), II (moderate, 3-4 points), III (severe, =5 points).	day 9
Secondary	COTE comorbidity index (annex 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
Secondary	Charlson comorbidity index (InCC) (Annex 10)	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
Secondary	HADS questionnaire (Annex 11)	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
Secondary	CAT Scale (Annex 12)	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
Secondary	Modified MRC scale (Annex 13)	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
Secondary	PROactive questionnaire (Annex 14)	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
Secondary	Accelerometer (Annex 15)	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
Secondary	Proof of the march (PM6M) (Annex 16)	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
Secondary	Questionnaire on motivation to perform physical activity.	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