Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. The purpose of this study is to evaluate whether a tele-pulmonary rehabilitation (TPR) program can improve the rates of treatment initiation and adherence among patients with chronic lung diseases compared to traditional, center-based pulmonary rehabilitation. Additionally, the study will assess improvements in quality of life, physical symptoms, and safety in both groups.
This study will enroll 90 patients from two medical centers in Israel (Tel Aviv and Barzilai). Participants will be randomly assigned to one of two groups:
1. The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center. 2. The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.
COPD with an FEV1 below 50% or with severe exacerbation (hospitalization) in the previous year or two moderate exacerbations in the previous year.
Interstitial lung disease with an FVC below 80% or a DLCO below 60%.
Bronchiectasis with at least two exacerbations in the past year or at least one hospitalization, and an FEV1 below 80%.
Pulmonary arterial hypertension.
Uncontrolled comorbidity (e.g uncontrolled congestive heart failure)
Inability to operate the mobile application.
Without a mobile device or computer.
A hospitalization in the 2-months prior to randomization.
Parallel
Tele-Rehabilitation
Other interventionParticipants will undergo a 12 weeks tele-rehabilitation program using a dedicated application. The intervention consists of 24 online sessions (twice weekly) led by a senior respiratory physiotherapist in groups of up to 5 participants. The sessions include: 1. Supervised Exercise: Aerobic and resistance training using household items, stretching, and breathing techniques. 2. Remote Monitoring: Vital signs (heart rate and oxygen saturation) monitored every 10-15 minutes via a study-provided pulse oximeter. 3. Comprehensive Education: Guidance on lifestyle, nutrition, and physical activity. 4. Digital Support: The app provides activity tracking, symptom logging, session reminders, and guided home exercises. At the end of each session, every participant receives a personalized exercise plan based on their performance and preferences, which is displayed in the app.
Adherence to pulmonary rehabilitation Between the Study Groups
Adherence will be defined as initiation of pulmonary rehabilitation in 3 months from study inclusion and completion of at least 50% (12 sessions) of the program (regular/remote based on allocation) within 6 months from inclusion.
Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation
Any safety events occurring during the Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation sessions (intervention/control group accordingly) or at the following 48 hours after. Safety events will be reported by the physiotherapist or treating physicians and assessed at every follow-up phone call. Each presumed safety event will be evaluated by the research team to decide about relevance and causality to the TPR/PR. Rates of safety events will be compared between the groups and will also be reported descriptively. Severity of adverse events will be determined based on the WHO International Classification for Patient Safety, and classified into mild (where no or minimal intervention were required), moderate (requiring treatment or permanent or long-term harm or loss of function) and (severe resulted in shortening of life expectancy or major permanent or long-term harm or loss of function).
Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate
Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session.
Global Evaluation of Treatment Effectiveness (GETE) score
Patient satisfaction with the tele-pulmonary rehabilitation \\ traditional rehabilitation program assessed using the Global Evaluation of Treatment Effectiveness (GETE) scale. The GETE is a measure of perceived treatment effectiveness, with responses between 1 (Complete control of the disease following the treatment) to 5 (Worsening of the disease following the treatment).
Respiratory Symptoms Burden Assessed by CAAT
Will be evaluated using the tools CAAT (Chronic Airways Assessment Test) eight question questionnaire on respiratory symptoms, confidence, sleep, and energy. The result is a score between 0-40. The score will be compared between the study groups.
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Tel-Aviv Sourasky Medical Center
Lead sponsor
Barzilai Medical Center
Collaborator
International Respiratory Coalition (IRC)
Collaborator
