Digital Health Integration With Pulmonary Rehabilitation on Ventilatory, Cognitive and Physical Functions and Sleep Quality in Patients With Chronic Obstructive Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁)
研究概览
简要总结
It is an interventional study in which 60 COPD patients are estimated to enroll according to random allocation and divided into two groups. The study group will receive telepulmonary rehabilitation with usual care, while the control group will stick to usual care only.
spirometry, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced expiratory volume in six seconds (FEV6), the FEV1/FVC ratio, forced expiratory flow at 25-75% of pulmonary volume (FEF25-75%), and peak expiratory flow (PEF). Cognitive domains will be measured using smartphone tests. Physical performance will be evaluated using self-administered Timed Up and Go (Self TUG), five times sit to stand (Self 5×STS), and six-minute walk tests (Self 6MWT). Sleep outcomes included sleep quality, efficiency, onset latency, wake after sleep onset, and total sleep time.
详细描述
PURPOSE:
to evaluate the efficacy of Digital Health Integration with pulmonary rehabilitation on ventilatory, cognitive and physical functions in patients with chronic obstructive lung disease.
BACKGROUND:
chronic obstructive pulmonary diseases are conditions characterized by a variable progression. Some individuals experience longer asymptomatic periods while others acute worsening periods and/or exacerbations triggered by symptom multiplication factors. Medications are adjusted to the patients' respiratory function, self-assessment of health and emerging certain physical changes. A more effective treatment may be applied by real-time data registered during the patient's everyday life Effective, safe, accessible, and engaging digital healthcare solutions which are able to be integrated into global healthcare systems may play a role in helping to meet this demand in COPD care needs. Digital interventions are unrestricted by individual practices or healthcare systems and come in a range of forms, including synchronous applications (apps) which provide real-time video conferencing or telephone calls; asynchronous solutions such as emails, smartphone messages, or notifications; remote monitoring or recording devices, such as traditional telehealth interventions; information-providing devices; and modern multi-tooled digital health apps that can facilitate behavioral changes and self-management.
HYPOTHESES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All gender COPD patients
- •Age will be 55-65 years.
- •• Medically stable
排除标准
- •Very severe COPD - Lung cancer
- •Lung resection - Lung fibrosis
- •Heart failure - Cognitive disorders that affect the device application
- •Musculoskeletal or neurological disorders that interfere with exercise program
- •requiring invasive or non-invasive positive pressure ventilation
- •inability to speak in complete sentences due to breathlessness
- •suspected elevated intracranial pressure - hemodynamic instability
- •recent facial, oral, or skull surgery
- •active hemoptysis (more than two tablespoons of frank blood per day)
- •pneumothorax - failure to comply with the research protocol.
- •uncontrolled hypertension, or other concomitant respiratory diseases
- •participate at any research or pulmonary rehabilitation program during the period of this study.
- •imaging changes of lung disease such as occupancy, exudation and interstitial changes on CT scan.
结局指标
主要结局
pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁)
时间窗: 10 weeks
Forced Expiratory Volume in 1 Second (FEV₁) FEV₁ will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₁ (L).
pulmonary function: Forced Vital Capacity (FVC)
时间窗: 10 weeks
Forced Vital Capacity (FVC) FVC will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FVC (L).
pulmonary function: FEV₁/FVC Ratio
时间窗: 10 weeks
FEV₁/FVC Ratio The FEV₁/FVC ratio will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₁/FVC (%).
pulmonary function: Peak Expiratory Flow (PEF)
时间窗: 10 weeks
Peak Expiratory Flow (PEF) PEF will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as PEF (L/s).
pulmonary function: Forced Expiratory Volume in 6 Seconds (FEV₆)
时间窗: 10 weeks
Forced Expiratory Volume in 6 Seconds (FEV₆) will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₆ (L).
pulmonary function: Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)
时间窗: 10 weeks
Forced Expiratory Flow 25-75% (FEF₂₅-₇₅) FEF₂₅-₇₅ will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEF₂₅-₇₅ (L/s).
次要结局
- cognitive function(10 weeks)
- physical activity: Self-Timed Up and Go (Self TUG)(10 weeks)
- physical activity: Self-Five Times Sit to Stand (Self STS)(10 weeks)
- physical activity: Self 6-Minute Walk Test (Self 6MWT)(10 weeks)
- Sleep Quality(10 weeks)
研究者
marwa mahmoud elsayed mahmoud
assistant professor
Cairo University