Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer), Exercise Programme.
- Кому может быть актуально
- Состояния в реестре: COPD Exacerbation. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство Teknikel Spirobank Home Type Respiratory Function Tester (Homespirometer)
Pulmonary Function Test (PFT): Pulmonary function test will be performed with a Teknikel Spirobank home pulmonary function test device. In the study group, the patient will make weekly measurements at home and send it to the physiotherapist. In the control group, evaluation will be made with the device only at the beginning and end of the treatment. - Другое Exercise Programme
Exercise Program * Breathing exercises: Chest, diaphragmatic breathing and lower basal breathing exercises will be performed with 10 repetitions. * Resistance exercises: Strengthening exercises will be performed on the major muscle groups of the upper and lower extremities by using medium hardness therabant. During the exercises, the patient's fatigue and dyspnea levels will be questioned using the Borg scale, and breaks will be given when necessary. The exercises will be performed with a mediu
Первичные конечные точки
- Number of exacerbations follow-up [Срок оценки: 1 month after the evaluation]
- Number of hospital admissions [Срок оценки: 1 month after the evaluation]
- Number of exacerbations follow-up [Срок оценки: 3 month after the first evaluation]
- Number of exacerbations follow-up [Срок оценки: 6 month after the first evaluation]
- Number of exacerbations follow-up [Срок оценки: 12 month after the first evaluation]
- Number of hospital admissions [Срок оценки: 3 month after the first evaluation]
- Number of hospital admissions [Срок оценки: 6 month after the first evaluation]
- Number of hospital admissions [Срок оценки: 12 month after the first evaluation]
Вторичные конечные точки (12)
- Pulmonary Function Test (PFT) with home spirometry for FVC (Forced Vital Capacity) value [Срок оценки: Baseline to one year]
- Daily Saturation Monitoring [Срок оценки: Baseline to one year]
- Symptom scoring [Срок оценки: Baseline to one year]
- Peripheral muscle strength measurement [Срок оценки: Baseline to one year]
- 6 minutes walking test [Срок оценки: Baseline to one year]
- Modified medical Council Dyspnea score [Срок оценки: Baseline to one year]
- Determination of quality of life [Срок оценки: Baseline to one year]
- Psychological status assessment [Срок оценки: Baseline to one year]
- Cognitive status assessment [Срок оценки: Baseline to one year]
- Physical activity level [Срок оценки: Baseline to one year]
- Heart Rate Monitoring [Срок оценки: Baseline to one year]
- Pulmonary Function Test (PFT) with home spirometry for FEV1 (Forced Expiratory Volume First Second) value [Срок оценки: Baseline to one year]
Критерии участия
Критерии включения
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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Turkey (Türkiye) · 1 центр
- SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital — Istanbul
Идентификаторы
NCT: NCT05738720 · Homespirometry1