Clinical Trials Directory

Trials / Completed

CompletedNCT06582082

Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lung Disease

Digital Health Integration With Pulmonary Rehabilitation on Ventilatory, Cognitive and Physical Functions and Sleep Quality in Patients With Chronic Obstructive Lung Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
50 Years – 60 Years
Healthy volunteers
Not accepted

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.

Detailed 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?

Conditions

Interventions

TypeNameDescription
OTHERtelepulmonary rehabilitation plus usual careThe study group will receive telepulmonary rehabilitation and usual care
OTHERusual carethe control group will stick to usual care

Timeline

Start date
2024-09-10
Primary completion
2025-12-30
Completion
2026-02-28
First posted
2024-09-03
Last updated
2026-03-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06582082. Inclusion in this directory is not an endorsement.