Clinical trial NCT06224075: Task-specific Training for Patients With Acute Exacerbation of COPD
Official title: Task-specific Training for Patients With Acute Exacerbation of COPD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Chronic Obstructive Pulmonary Disease (COPD) experience a progressive deterioration in their quality of life. Task-specific training is a type of approach focused on chronic patients that allows the acquisition of new skills or improvement of lost skills. The overall objective of this project is to evaluate the effectiveness of a task-specific training program during hospitalization of patients with acute exacerbation of COPD. A randomized clinical trial will be conducted in patients hospitalized for COPD. Participants after signing informed consent will be randomized between the control group (standard treatment) and the intervention group (task-specific training program in addition to standard treatment). The task-specific training program is a multidisciplinary program divided into three blocks where specific tasks will be performed on symptom education, education of activities of daily living and improvement of physical capacity with the aim of reinforcing skills necessary for the self-management of COPD patients in the short, medium and long term.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for acute exacerbation of COPD.
* Over 18 years of age.
* Who wish to participate in the study.
* Who sign the informed consent form.

Exclusion Criteria:

* Patients with inability to provide informed consent.
* Presence of psychiatric or cognitive disorders, organ failure, cancer and/or inability to cooperate.
* Patients who had experienced exacerbation of COPD in the previous month were also excluded.

Primary outcomes:
measure: Modified Borg Scale
timeFrame: Baseline, hospital discharge, 1 month, 3 months and 6 months
measure: COPD Assessment Test (CAT)
timeFrame: Baseline, hospital discharge, 1 month, 3 months and 6 months
measure: EuroQol-5D (EQ-5D)
timeFrame: Baseline, hospital discharge, 1 month, 3 months and 6 months
measure: Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q)
timeFrame: Baseline, 1 months and 6 months
measure: Test of Adherence to Inhalers (TAI)
timeFrame: Baseline, hospital discharge, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: Baseline and hospital discharge
measure: Pressure expiratory force (PEF)
timeFrame: Baseline and hospital discharge
measure: Pressure inspiratory force (PIF)
timeFrame: Baseline and hospital discharge
measure: Technique of the inhaler
timeFrame: Baseline and hospital discharge
measure: Postural evaluation
timeFrame: Baseline and hospital discharge
measure: Patient activation measure (PAM)
timeFrame: Baseline, 1 month and 6 months
measure: Fatigue Severity
timeFrame: Baseline, hospital discharge, 1 month, 3 months and 6 months
Other outcomes:
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, Chair
role: STUDY_DIRECTOR
References: