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临床试验/NCT07068269
NCT07068269已完成不适用

Effects of Self-management Program of Activity Coping and Education on Quality of Life, Self-efficacy, Exercise Capacity and Anxiety and Depression in Patients With COPD

Riphah International University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
St George Respiratory Questionnaire

研究概览

简要总结

The prevalent, preventable, and treatable condition known as chronic obstructive pulmonary disease (COPD) is characterized by ongoing respiratory symptoms and restricted airflow caused by abnormalities of the airways and alveoli. Dyspnea, coughing, sputum production, and exacerbations are among the chronic respiratory symptoms of COPD. The objective of this study is to determine the effects of self-management program of activity coping and education on quality of life, self-efficacy, exercise capacity and anxiety and depression in patients with COPD. People with COPD should be given self-management support, according to national and international recommendations for managing the condition. Hospitalizations, COPD-specific health expenses, and health-related quality of life have all been demonstrated to improve when people with COPD receive interventions that promote self-management.

The study will be randomized clinical trial. Patients age between 45 to 60 years and diagnosed with COPD will be included. The Group A will receive self-management program of activity coping and education for 6 weeks whereas the Group B will receive routine physical therapy for 6 weeks. Pulmonary function testing will be used to evaluate the severity of COPD, St George Respiratory Questionnaire will be used to determine the quality of life, and Self-efficacy of patients will be assessed by COPD Self-efficacy Scale, 6-minute walk test will be used to find the exercise capacity of participants and anxiety and depression will be measured by the Hospital Anxiety and Depression Scale. Data will be analyzed using SPSS version 26.

详细描述

The prevalent, preventable, and treatable condition known as chronic obstructive pulmonary disease (COPD) is characterized by ongoing respiratory symptoms and restricted airflow caused by abnormalities of the airways (bronchitis) and/or alveoli (emphysema), which are typically brought on by prolonged exposure to harmful particles or gases. Dyspnea, coughing, sputum production, and exacerbations are among the chronic respiratory symptoms of COPD. COPD is a global public health issue and one of the main causes of death and illness, particularly in developing nations. Approximately 30 million Americans are thought to suffer from COPD. Up to half of them are not even aware that they have it. The leading cause of chronic disease, COPD is expected to rank seventh globally in terms of disease burden by 2030. According to estimates, the prevalence of COPD in individuals over 40 is between 4 and 20% worldwide, and 6.3% in Asians. In addition, it is the fourth most frequent reason for hospitalization and the biggest financial burden among chronic illnesses affecting elderly patients.

People with COPD should be given self-management support, according to national and international recommendations for managing the condition. Hospitalizations, COPD-specific health expenses, and health-related quality of life have all been demonstrated to improve when people with COPD receive interventions that promote self-management. Although self-care is implied by the name "self," self-management always entails collaboration with a health care provider, who plays a supportive role. In general, COPD self-management programs are designed to give participants the skills necessary to follow long-term disease-specific medication regimes. The goals of SPACE for COPD, a Self-Management Program of Activity Coping and Education, are to help individuals with COPD manage daily tasks, reduce symptom load, encourage behavior changes that improve health, and improve psychological well-being. Programs for self-management should include physical activity, quitting smoking, managing social interactions, managing medications, and being able to identify and react to symptoms. The SPACE for COPD guidebook, which incorporates both general self-management techniques and disease-specific activities, serves as the framework for the program. Few studies have attempted to assess the cost-effectiveness of self-management programs for individuals with COPD. Some studies simply included the program's expenses. Self-management programs have been shown to be cost-effective in both lowering costs and improving patient outcomes.

This study is significant because it has the potential to concentrate on non-pharmacological interventions, such as self-management programs. A self-management program (SMP) for COPD is a patient-oriented approach that enables the patient to take charge of their condition through appropriate choice making, physical activity, emotional management, education on a continuous basis and encouraging adherence to the treatment plans. Such a program aims at enhancing the quality of life of the patient, and decreasing the frequency of exacerbations while increasing the overall functional ability of the patient. Moreover it reduces hospital admissions and emergency room visits which can alleviate pressure on healthcare systems. Self-management program (SMP) can raise awareness about COPD leading to greater community support. Improved management of symptoms can lead to a more active lifestyle for patients, benefiting overall societal health and productivity.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male and female
  • •Age 40-65 years
  • •Participants are eligible for the trial if they have an established diagnosis of COPD as defined by The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria

排除标准

  • •Unable to participate in the exercise component of the SPACE for COPD programme due to neurological, locomotive or psychiatric disability
  • •Unable to participate in the exercise component of the SPACE for COPD programme due to other comorbidities where exercise would be a contraindication (e.g., unstable angina)

研究组 & 干预措施

Group A

Experimental

Self-Management Program

干预措施: Self-Management Program (Other)

Group B

Active Comparator

Routine Physical Therapy Exercise

干预措施: Routine Physical Therapy Exercises (Other)

结局指标

主要结局

St George Respiratory Questionnaire

时间窗: Baseline, 3rd Week, 6th Week

St. George's Respiratory Questionnaire (SGRQ) is a 50-item survey measuring health impairment in COPD/asthma patients, with scores from 0 to 100 (higher = worse health). It calculates three domain scores-Symptoms, Activity, Impacts-and a Total Score. A 4-unit change is considered clinically relevant.

COPD Self-Efficacy Scale

时间窗: Baseline, 3rd Week, 6th Week

The COPD Self-Efficacy Scale (CSES) measures a patient's confidence in managing breathing difficulties across various situations, typically using a 5-point Likert scale (5=Very confident, 1=Not at all confident). Total scores, or mean scores for subscales, indicate higher self-efficacy with higher values, often used to assess coping with physical exertion and emotional distress. Each of the 34 items (or 24/51 in some modified versions) is rated from 1 to 5. Total/Mean Score: Sum the responses and divide by the number of items (often 34) to get a mean score. A higher mean score indicates greater self-efficacy (confidence in managing symptoms). A mean score of 3 or higher suggests some degree of confidence.

Hospital Anxiety and Depression Scale

时间窗: Baseline, 3rd Week, 6th Week

The Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-report tool (7 anxiety, 7 depression) scoring 0-21 per subscale. Each item is scored 0-3. Scores of 0-7 are considered normal, 8-10 borderline/mild, and 11-21 indicate a probable, clinically significant case.

FEV1

时间窗: Baseline, 3rd Week, 6th Week

FEV1 (Forced Expiratory Volume in the first second) is a crucial pulmonary function test that measures the volume of air forcefully exhaled in the first second of a deep breath. It assesses how quickly lungs can empty, making it vital for diagnosing and monitoring obstructive diseases like COPD.

FVC

时间窗: Baseline, 3rd Week, 6th Week

Forced Vital Capacity (FVC) is a key spirometry measurement representing the total amount of air a person can forcibly exhale after taking a deep breath, typically measuring around liters in healthy adults. It is critical for diagnosing lung diseases (COPD, fibrosis), with low values indicating restrictive patterns or severe obstruction

PEF

时间窗: Baseline, 3rd Week, 6th Week

Peak Expiratory Flow (PEF) is a quick,, portable, and non-invasive pulmonary function test (PFT) measuring the maximum speed of exhalation, primarily used for diagnosing and monitoring asthma and chronic obstructive pulmonary disease (COPD). Using a peak flow meter, individuals record their highest reading to assess airway obstruction and manage medication.

6-min walk Distance

时间窗: Baseline, 3rd Week, 6th Week

The 6-Minute Walk Test (6MWT) measures the distance (6MWD) a person can walk on a flat, hard surface in 6 minutes, with healthy adults typically covering 400 to 700 meters. It assesses functional capacity, with lower distances indicating increased risk for illness or, specifically for surgery, a higher risk of complications if under 500 meters.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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