The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of hospital admissions
研究概览
简要总结
The study is a randomized controlled trial. The cases will be divided into two groups as the Homespirometer group and the control group. Breathing exercises, aerobic exercise and peripheral muscle strengthening will be performed in both groups. A home-type spirometer will be given to the homespirometer group and it will be requested to send the spirometric measurement every week. The cases will be called to the hospital for control and evaluated at baseline, 3rd, 6th and 12th months. Evaluations include assessments such as exercise capacity measurement, muscle strength measurement, disease attack frequency, symptom scoring.
详细描述
Pulmonary Rehabilitation (PR) is a comprehensive intervention designed to improve not only exercise, education and behavioral changes, but also the physical and psychological state of individuals, based on detailed patient evaluation and subsequent patient-specific therapies in individuals with chronic respiratory disease. It is integrated into the lifelong care and management of the chronic respiratory patient. It requires an active collaboration between the patient, family, and the Pulmonary Rehabilitation team. Due to the complex nature of respiratory diseases, many disciplines should be involved in the maintenance of treatment.
Pulmonary rehabilitation is a useful treatment component in almost all chronic respiratory patients, especially COPD (Chronic obstructive pulmonary disease). There are studies showing that it reduces the number of attacks and the frequency of hospitalization even in COPD patients with frequent attacks. As pulmonary rehabilitation methods; It is possible to see that there are many types such as supervised exercise programs in the hospital, telephone monitoring or home programs.In-hospital supervised programs are time-consuming and costly applications. This situation causes an increase in the tendency towards applications without direct supervision and increases the need for studies on the effectiveness and benefits of these applications.
The use of home-type spirometers are practical devices that provide close monitoring of respiratory functions and enable the detection of disease symptoms in a short time. The use of these devices has increased especially during the pandemic period. In a study conducted with asthma patients, it was reported that early diagnosis and intervention is possible in cases with self-monitoring by mobile spirometry. In another study, in which e-monitoring of cases with duchenne muscular dystrophy (DMD) was performed with a spirometer device during the covid 19 pandemic, the importance of regular spirometric follow-ups of DMD cases as a part of their daily routine and making it a part of health care services was emphasized.
In our study, advanced stage COPD cases constitute the case group. The exacerbation and hospital admission rates are extremely high in these patients. There are also transfer problems to the hospital due to existing physical limitations. With the planned study, close follow-up of the patients with the help of home-type spirometry will be carried out over a 1-year period, and a pulmonary rehabilitation exercise program will be applied in this process. The effect of the applied follow-up and exercise program on disease exacerbation and hospital admission rates will be examined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18-75
- •Having a diagnosis of COPD stages C and D diagnosed according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) clinical diagnostic criteria
- •Presence of dyspnea on exertion
- •Stable clinical condition at the time of inclusion without infection or exacerbation in the previous 4 weeks
- •Having the ability to use a smart phone and spirometer after training
排除标准
- •Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
- •A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- •Participation in a pulmonary rehabilitation program within the past 12 months.
结局指标
主要结局
Number of hospital admissions
时间窗: 12 month after the first evaluation
After the first evaluation, he will be questioned at the 12th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device.
Number of exacerbations follow-up
时间窗: 12 month after the first evaluation
After the first evaluation, he will be questioned at the 12th month follow-ups. Apart from this, patients will be asked to write in the notes section and contact the researchers in case of exacerbation through the spirometer device.
次要结局
- 6 minutes walking test(Baseline to one year)
- Modified medical Council Dyspnea score(Baseline to one year)
- Psychological status assessment(Baseline to one year)
- Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value(Baseline to one year)
- Daily Saturation Monitoring(Baseline to one year)
- Peripheral muscle strength measurement(Baseline to one year)
- Determination of quality of life(Baseline to one year)
- Pulmonary Function Test (PFT) with home spirometry for FEV1/FVC (Tiffeneau indeksi) value(Baseline to one year)
- Physical activity level(Baseline to one year)
- Symptom scoring(Baseline to one year)
- Heart Rate Monitoring(Baseline to one year)
- Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value(Baseline to one year)
- Cognitive status assessment(Baseline to one year)
研究者
ESRA PEHLIVAN
Assoc. Prof. Dr.
Saglik Bilimleri Universitesi