Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lung Disease
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Details and patient eligibility
About
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.
Full description
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:
Digital health integration with pulmonary rehabilitation has no effect on ventilatory, cognitive, physical functions, and sleep quality in patients with chronic obstructive lung disease.
RESEARCH QUESTION:
Does digital health integration with pulmonary rehabilitation influence ventilatory, cognitive, , physical functions, and sleep quality in patients with chronic obstructive lung disease?
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Marwa Mahmoud, PhD
Data sourced from clinicaltrials.gov
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