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

NCT06582082 | Completed

• 1 other identifier: P.T.REC/012/005239
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• cognitive function

  10 weeks

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

  10 weeks

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

  10 weeks

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

  10 weeks

• Sleep Quality

  10 weeks

Study Arms (2)

telepulmonary rehabilitation

EXPERIMENTAL

The study group will receive telepulmonary rehabilitation besides usual care

Other: telepulmonary rehabilitation plus usual care; Other: usual care

usual care

ACTIVE COMPARATOR

the control group will stick to usual care only

Other: usual care

Interventions

telepulmonary rehabilitation plus usual care OTHER

The study group will receive telepulmonary rehabilitation and usual care

telepulmonary rehabilitation

usual care OTHER

the control group will stick to usual care

telepulmonary rehabilitation; usual care

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All gender COPD patients
• Age will be 55-65 years.
• Medically stable

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: September 10, 2024
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: two years
• Access Criteria: up on appropriate request of corresponding author

Locations

EG (1)