Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lun… (NCT06582082) | Clinical Trial Compass
CompletedNot Applicable
Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lung Disease
Egypt60 participantsStarted 2024-09-10
Plain-language summary
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.
Who can participate
Age range
50 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All gender COPD patients
* Age will be 55-65 years.
* • Medically stable
* Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁)
Timeframe: 10 weeks
2
pulmonary function: Forced Vital Capacity (FVC)
Timeframe: 10 weeks
3
pulmonary function: FEV₁/FVC Ratio
Timeframe: 10 weeks
4
pulmonary function: Peak Expiratory Flow (PEF)
Timeframe: 10 weeks
5
pulmonary function: Forced Expiratory Volume in 6 Seconds (FEV₆)