Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients (COPD)
17 maj 2014 uppdaterad av: Marie Carmen Valenza, Universidad de Granada
Clinical Profile and Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients
Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life.
The hypothesis of this study is to examine the relationship between cognitive status and clinical profile (respiratory, sleep quality, nutritional status) in patients with chronic obstructive pulmonary disease in two different moments: exacerbation or stable situation.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Chronic obstructive pulmonary disease is a pathology with a systemic impact with a progressive evolution that is characterized by the presence of chronic airflow obstruction.
Patients with COPD may have problems with cognitive functioning, either globally or in single cognitive domains, such as information processing, attention and concentration, memory, executive functioning and self-regulation.
Several studies have determined the prevalence of cognitive impairment in COPD compared to healthy control subjects, reaching very high levels, 36% of COPD patients with mild cognitive impairment compared with 12 % non- COPD subjects.
Studietyp
Observationell
Inskrivning (Förväntat)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Granada, Spanien, 18071
- Rekrytering
- Department of Physical Therapy
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients diagnosed of chronic obstructive pulmonary disease.
Beskrivning
Inclusion Criteria:
- Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable.
- Signed written consent.
- Medical approval for inclusion
Exclusion Criteria:
- Heart disease.
- Neurological patients.
- Severe cognitive impairment in order not to complete the assessment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Stable and exacerbated patients
Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation.
Cognitive assessment of these patients will be performed.
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Patients are going to be assessed regarding the outcome measures
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Cognitive impairment
Tidsram: Baseline
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The cognitive impairment will be measured using the Montreal Cognitive Assessment.
The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
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Baseline
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Sleep quality
Tidsram: Baseline
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Participants are going to complete the Pittsburgh Quality of Sleep Index.
This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
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Baseline
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Activity monitoring
Tidsram: Baseline
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The accelerometer Armband is going to be used for activity monitoring.
It measures the intensity of the activity during 12 hours.
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Baseline
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Nutritional state
Tidsram: Baseline
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Mini Nutritional Assessment has been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes.
It is composed of simple measurements and brief questions that can be completed in about 10 min
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Baseline
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Quality of life
Tidsram: Baseline
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Quality of life associated with health is going to be measured with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
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Baseline
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Cough
Tidsram: Baseline
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The Leicester Cough Questionnaire-acute is a validated cough-related health status questionnaire designed for patients with chronic cough.
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Baseline
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Comorbidities
Tidsram: Baseline
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Comorbidities are going to be measured with the Charlson comorbidity index.
The Charlson comorbidity index predicts the ten-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions).
Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.
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Baseline
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Anxiety and depression
Tidsram: Baseline
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Patients are going to completed the Hospital Anxiety and Depression Scale composed of statements relevant to either generalized anxiety or depression.
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Baseline
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Cognitive flexibility
Tidsram: Baseline
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The cognitive flexibility of patients is measured using the Trial Making Test.
This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.
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Baseline
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Forced vital capacity
Tidsram: Baseline
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Forced vital capacity is going to be measured with a spirometer as recommended by the American Thoracic Society
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Baseline
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Forced expiratory volume in the first second
Tidsram: Baseline
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Forced expiratory volume in the first second is going to be measured with a spirometer as recommended by the American Thoracic Society
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Baseline
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Förväntat)
1 augusti 2014
Avslutad studie (Förväntat)
1 december 2014
Studieregistreringsdatum
Först inskickad
17 maj 2014
Först inskickad som uppfyllde QC-kriterierna
17 maj 2014
Första postat (Uppskatta)
21 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 maj 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DF0051UG
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .