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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Lung Disease
• Intervention / Treatment: Other: telepulmonary rehabilitation plus usual care; Other: usual care

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?

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telepulmonary rehabilitation; The study group will receive telepulmonary rehabilitation besides usual care	Other: telepulmonary rehabilitation plus usual care; The study group will receive telepulmonary rehabilitation and usual care; Other: usual care; the control group will stick to usual care
Active Comparator: usual care; the control group will stick to usual care only	Other: usual care; the control group will stick to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁)	Forced Expiratory Volume in 1 Second (FEV₁) FEV₁ will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₁ (L).	10 weeks
pulmonary function: Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) FVC will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FVC (L).	10 weeks
pulmonary function: FEV₁/FVC Ratio	FEV₁/FVC Ratio The FEV₁/FVC ratio will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₁/FVC (%).	10 weeks
pulmonary function: Peak Expiratory Flow (PEF)	Peak Expiratory Flow (PEF) PEF will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as PEF (L/s).	10 weeks
pulmonary function: Forced Expiratory Volume in 6 Seconds (FEV₆)	Forced Expiratory Volume in 6 Seconds (FEV₆) will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEV₆ (L).	10 weeks
pulmonary function: Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)	Forced Expiratory Flow 25-75% (FEF₂₅-₇₅) FEF₂₅-₇₅ will be measured using a Bluetooth-enabled, app-linked spirometer (MIR Spirobank Smart; Medical International Research, Italy) during supervised videoconference sessions at baseline and 10 weeks. Participants will perform coached forced expiratory manoeuvres with real-time quality feedback, and the best acceptable effort will be retained for analysis. Testing will adhere to the 2019 ATS/ERS Spirometry Technical Standard. The outcome will be recorded as FEF₂₅-₇₅ (L/s).	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive function	Global Cognitive Function Measured by the Brain OK Smartphone-Based Cognitive Assessment Total Score will be assessed using the Brain OK cognitive battery during standardized smartphone-based testing sessions at baseline and 10 weeks. Brain OK testing attention, memory, visuospatial ability, language, and executive function. The outcome will be recorded as the Brain OK total score (0-22 points), with higher scores indicating better cognitive function.	10 weeks
physical activity: Self-Timed Up and Go (Self TUG)	The Self TUG will use the smartphone's inertial measurement unit secured at the waist or mid-thigh. The application will segment the sit-to-stand, gait, turning, and return-to-sit phases to calculate total time (seconds). Supervised video sessions will ensure consistent chair height and walking path across assessments. Smartphone-based TUG self-assessments have demonstrated strong validity and reliability, supporting their use in remote mobility monitoring. Shorter completion time indicates better performance.	10 weeks
physical activity: Self-Five Times Sit to Stand (Self STS)	TLower limb functional strength will be assessed using a standardized chair (≈43-45 cm). Participants will complete five arms free sit to stand repetitions as quickly as possible. The application will automatically record total time (s) and phase specific metrics. Therapists will verify chair height, foot placement, and safety before each trial. Remote administration of the 5×STS has shown excellent inter and intra rater reliability.	10 weeks
physical activity: Self 6-Minute Walk Test (Self 6MWT)	TFunctional exercise capacity will be measured with an app guided 6MWT performed on a flat indoor or outdoor path while participants carry a smartphone with accelerometer/GPS enabled. The algorithm will calculate total distance (m), One minute prompts and automated pause detection will support protocol adherence. Smartphone based self administered 6MWT protocols have demonstrated high reliability and reproducibility for remote assessment. Greater distance better performance	10 weeks
Sleep Quality	Sleep quality will be assessed using both mobile application-based monitoring and overnight polysomnography (PSG) at baseline and at 10 weeks. Participants' habitual sleep will be monitored using the Sleep as Android mobile application, while overnight PSG will be used to obtain objective sleep-related measurements under standardized assessment conditions. The same procedures will be followed at both study time points to allow comparison of sleep patterns and sleep-related changes over time. Results will be derived from the recorded sleep assessment data obtained through these methods.	10 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: P.T.REC/012/005239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing study protocol with other researchers
• IPD Sharing Time Frame: two years
• IPD Sharing Access Criteria: up on appropriate request of corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No