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

NCT ID: NCT06582082

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-12-30

Brief Summary

It is an interventional study in which 60 COPD patients estimated to enrol according to random allocation and divided into two groups. The study group will receive pulmonary rehabilitation while the control group will stick to pursed lip breathing only.

Pulmonary function (FEV1, FVC, FEV1/FVC), cognitive function by mini mental state examination, physical function by physical tests also, physical activity and sleep by google fit app and vital signs by using different mobile apps. measurements will be evaluated before initiation of the interventions and 12 weeks thereafter.

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 which can facilitate behavioural changes and self-management..

HYPOTHESES:

Digital Health Integration with pulmonary rehabilitation has no effect on ventilatory, cognitive and physical functions in patients with chronic obstructive lung disease.

RESEARCH QUESTION:

Does Digital Health Integration with pulmonary rehabilitation influence ventilatory, cognitive and physical functions in patients with chronic obstructive lung disease?

Conditions

Chronic Obstructive Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

pulmonary rehabilitation

The study group will receive pulmonary rehabilitation

Group Type: EXPERIMENTAL

pulmonary rehabilitation

Intervention Type: OTHER

The study group will receive pulmonary rehabilitation

lip breathing

the control group will stick to pursed lip breathing only

Group Type: ACTIVE_COMPARATOR

pursed lip breathing

Intervention Type: OTHER

the control group will stick to pursed lip breathing only

Interventions

pulmonary rehabilitation

The study group will receive pulmonary rehabilitation

Intervention Type: OTHER

pursed lip breathing

the control group will stick to pursed lip breathing only

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa mahmoud elsayed mahmoud

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Marwa Mahmoud, PhD

Role: CONTACT

marwadd999@gmail.com

01156033818

Facility Contacts

Marwa Mahmoud, PhD

Role: primary

Other Identifiers

P.T.REC/012/005239

Identifier Type: -

Identifier Source: org_study_id