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OpenTrials
Completed

NCT Number: NCT06582082

Digital Health Integration With Pulmonary Rehabilitation on 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.

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Key information

Conditions

Chronic Obstructive Lung Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, Egypt

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

telepulmonary rehabilitation plus usual care

Other

The study group will receive telepulmonary rehabilitation and usual care

Usual Care

Other

the control group will stick to usual care

Primary outcomes

  1. pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁)

    Time frame: 10 weeks

    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).

  2. pulmonary function: Forced Vital Capacity (FVC)

    Time frame: 10 weeks

    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).

  3. pulmonary function: FEV₁/FVC Ratio

    Time frame: 10 weeks

    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 (%).

  4. pulmonary function: Peak Expiratory Flow (PEF)

    Time frame: 10 weeks

    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).

  5. pulmonary function: Forced Expiratory Volume in 6 Seconds (FEV₆)

    Time frame: 10 weeks

    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).

  6. pulmonary function: Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)

    Time frame: 10 weeks

    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).

Secondary outcomes

  1. cognitive function

    Time frame: 10 weeks

    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.

  2. physical activity: Self-Timed Up and Go (Self TUG)

    Time frame: 10 weeks

    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.

  3. physical activity: Self-Five Times Sit to Stand (Self STS)

    Time frame: 10 weeks

    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.

  4. physical activity: Self 6-Minute Walk Test (Self 6MWT)

    Time frame: 10 weeks

    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

  5. Sleep Quality

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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