Chronic Obstructive Lung DiseaseNCT06582082
Digital Health Integration With Pulmonary Rehabilitation on Patients With Chronic Obstructive Lung Disease
A study of Chronic Obstructive Lung Disease, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Chronic Obstructive Lung Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All gender COPD patients
- Age will be 55-65 years.
- • Medically stable
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Chronic Obstructive Lung Disease
- Being tested
- telepulmonary rehabilitation plus usual care, usual care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telepulmonary rehabilitation plus usual careOther
The study group will receive telepulmonary rehabilitation and usual care
usual careOther
the control group will stick to usual care
| Study group | Role | What they receive |
|---|---|---|
| telepulmonary rehabilitation | Experimental | The study group will receive telepulmonary rehabilitation besides usual care Receives: Other: telepulmonary rehabilitation plus usual care; Other: usual care |
| usual care | Active comparator | the control group will stick to usual care only Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 10 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start10 Sep 2024
- Primary completion30 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582082
- Sponsor's protocol ID
- P.T.REC/012/005239
- Status last verified
- Mar 2026
- First submitted
- 28 Aug 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing study protocol with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Integration With Pulmonary Rehabilitation on Ventilatory, Cognitive and Physical Functions and Sleep Quality in Patients With Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT06582082
- Acronym / sponsor ID
- P.T.REC/012/005239
- Conditions
- Chronic Obstructive Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telepulmonary rehabilitation | Experimental | Other: telepulmonary rehabilitation plus usual care, Other: usual careThe study group will receive telepulmonary rehabilitation besides usual care |
| usual care | Active comparator | Other: usual carethe control group will stick to usual care only |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All gender COPD patients
- Age will be 55-65 years.
- • Medically stable
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telepulmonary rehabilitation plus usual careThe study group will receive telepulmonary rehabilitation and usual care | Other | telepulmonary rehabilitation |
| usual carethe control group will stick to usual care | Other | telepulmonary rehabilitation, usual care |
Primary outcome
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).
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).
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 (%).
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).
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).
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).
5 secondary outcomes
cognitive function
Time frame: 10 weeks
physical activity: Self-Timed Up and Go (Self TUG)
Time frame: 10 weeks
physical activity: Self-Five Times Sit to Stand (Self STS)
Time frame: 10 weeks
physical activity: Self 6-Minute Walk Test (Self 6MWT)
Time frame: 10 weeks
Sleep Quality
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. sharing study protocol with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Obstructive Lung Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function: Forced Expiratory Volume in 1 Second (FEV₁) (time frame: 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.