Characterization of Variable MARrcha's Diary Variables as a Useful Measure of Physical Activity in Patients With Physical COPD in Patients With COPD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Minutes of daily walking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Minutes of daily walking
时间窗: 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: 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?
次要结局
- Date of inclusion in the study(day 9)
- Age(day 9)
- Sex(day 9)
- Size(day 9)
- FVC(day 9)
- Body Mass Index(day 9)
- Academic training(day 9)
- Marital Status(day 9)
- Family situation(day 9)
- Place of residence(day 9)
- Employment status(day 9)
- Description of instruments and measures(day 9)
- COTE comorbidity index (annex 9)(day 9)
- Proof of the march (PM6M) (Annex 16)(day 9)
- Weight(day 9)
- Number and scope of treatment of exacerbations suffered in the last year(day 9)
- Date of the last moderate-severe exacerbation.(day 9)
- BODE and BODEX Index (Annex 8)(day 9)
- HADS questionnaire (Annex 11)(day 9)
- Accelerometer (Annex 15)(from day 2 to 8)
- PROactive questionnaire (Annex 14)(day 9)
- Questionnaire on motivation to perform physical activity.(day 9)
- Socioeconomic level(day 9)
- Smoking(day 9)
- Date(day 9)
- FEV1(day 9)
- FEV1%(day 9)
- Phenotype of COPD(day 9)
- Non-pharmacological treatment(day 9)
- Scales, questionnaires and indexes(day 9)
- Spirometry(day 9)
- Charlson comorbidity index (InCC) (Annex 10)(day 9)
- CAT Scale (Annex 12)(day 9)
- Modified MRC scale (Annex 13)(day 9)
研究者
Ferran Morell
Director
Fundacio Catalana de Pneumologia