Task-specific Training for Patients With Acute Exacerbation of COPD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Modified Borg Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Task-specific training
干预措施: Task-specific training (Behavioral)
Task-specific training
干预措施: Usual care (Other)
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
Modified Borg Scale
时间窗: Baseline, hospital discharge, 1 month, 3 months and 6 months
the perceived dyspnoea is measure with the Borg Scale. This scale range from 0-10 where higher value indicate worse state, more dyspnoea.
Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q)
时间窗: Baseline, 1 months and 6 months
Evaluated at baseline by Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, \& Wallace, 2010). The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills. A higher punctuation indicates better results.
COPD Assessment Test (CAT)
时间窗: Baseline, hospital discharge, 1 month, 3 months and 6 months
It consists of eight questions covering cough, phlegm, chest tightness, breathlessness, activity limitations at home, confidence leaving home, sleep and energy. The items are graded from 0 to 5, giving a total score range from 0 to 40, where lower scores indicate fewer symptoms and a better quality of life.
EuroQol-5D (EQ-5D)
时间窗: Baseline, hospital discharge, 1 month, 3 months and 6 months
Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100. Higher score indicate higher quality of life. Better.
Test of Adherence to Inhalers (TAI)
时间窗: Baseline, hospital discharge, 1 month, 3 months and 6 months
This questionnaire has two forms, the first type being a 10-item to identify the patient's adherence status to inhalers. There are 2 other questions to check the degree of compliance. The 10-item form is scored from 1 (the poorest) to 5(the best) for each item, and the total score of the questionnaire ranges from 10 to 50 (a score of 45 or less indicates poor adherence, 46 to 49 is intermediate adherence, and 50 indicates good adherence
次要结局
- Forced expiratory volume in the first second (FEV1)(Baseline and hospital discharge)
- Pressure expiratory force (PEF)(Baseline and hospital discharge)
- Postural evaluation(Baseline and hospital discharge)
- Pressure inspiratory force (PIF)(Baseline and hospital discharge)
- Technique of the inhaler(Baseline and hospital discharge)
- Fatigue Severity(Baseline, hospital discharge, 1 month, 3 months and 6 months)
- Patient activation measure (PAM)(Baseline, 1 month and 6 months)
研究者
Marie Carmen Valenza
Chair of Physiotherapy
Universidad de Granada