Digital health integration with pulmonary rehabilitation for COPD patients
Digital Health Integration With Pulmonary Rehabilitation on Ventilatory, Cognitive and Physical Functions in Patients With Chronic Obstructive Lung Disease
This study is testing if adding digital health tools to pulmonary rehabilitation can help people with COPD feel better and improve their health over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06582082 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of integrating digital health solutions with pulmonary rehabilitation in patients suffering from chronic obstructive lung disease (COPD). A total of 60 participants will be randomly assigned to either a study group receiving pulmonary rehabilitation combined with digital health tools or a control group practicing only pursed lip breathing. The study will assess various outcomes, including pulmonary function, cognitive abilities, physical performance, and overall health metrics, before and after a 12-week intervention period. The goal is to determine if digital health integration can enhance the management and outcomes of COPD.
Who should consider this trial
Good fit: Ideal candidates for this study are COPD patients aged 55-65 years with moderate to severe disease and specific health criteria.
Not a fit: Patients with very severe COPD, lung cancer, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of COPD, leading to better respiratory, cognitive, and physical health outcomes for patients.
How similar studies have performed: While the integration of digital health in chronic disease management is a growing field, this specific approach combining digital health with pulmonary rehabilitation in COPD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All gender COPD patients * Age will be 55-65 years. * Moderate to severe COPD patients * emphysema on CT scan (HU ≥ - 900) * There FEV1 will be less than 80% predicted * Class II obesity (BMI of 35 to \< 40) * Medically stable * greater than 10 pack-year smoking history 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.
Where this trial is running
Cairo
- Faculty of Physical Therapy — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Marwa Mahmoud, PhD
- Email: marwadd999@gmail.com
- Phone: 01156033818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.