Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorTel-Aviv Sourasky Medical Center
About this trial
Pulmonary rehabilitation (PR) is a key non-pharmacological intervention for patients with chronic obstructive pulmonary disease (COPD), yet it remains underutilized, particularly among patients living in peripheral areas due to limited access, travel distance, and logistical barriers. Tele-pulmonary rehabilitation (TPR) has the potential to improve access to care, but its feasibility and effectiveness as a group-based intervention have not been well established.
The aim of this study is to evaluate whether a group-based TPR program can improve treatment initiation and adherence compared to usual care, defined as referral to standard PR, among COPD patients living in peripheral areas. In addition, the study will assess the effect of the intervention on COPD exacerbations, symptom burden, quality of life, and patient satisfaction.
This is a prospective randomized controlled trial that will enroll patients with COPD who are eligible for PR according to the Israeli health basket criteria and have not participated in PR in the past year. Participants will be randomly assigned to one of two groups: (1) referral to standard PR (control group), or (2) participation in a 12-week, twice-weekly, group-based TPR program delivered remotely via a dedicated application and video sessions (intervention group).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
FEV1 below 50%
Severe exacerbation (hospitalization) in the previous year
Two moderate exacerbations in the previous year
Willingness to initiate a PR or TPR programs.
Disqualifiers
Uncontrolled comorbidity (e.g uncontrolled congestive heart failure).
Inability to operate the mobile application.
Without a mobile device or computer.
An exacerbation in the 2-months prior to randomization.
Trial design
Design model
Parallel
Treatments tested in this trial
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 6 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Tele-RehabilitationExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.Secondary outcomes
1
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).
Time frame
Assessed from enrollment to 6 months following study initiation.2
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. Rates will be compared between the study groups.
Time frame
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.3
Respiratory Symptoms Burden Assessed by CAT
Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. The score will be compared between the study groups.
Time frame
Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.4
Number of Moderate and Severe COPD Exacerbations (6 months)
The number of moderate and severe COPD exacerbations will be assessed over the 6 months following study enrollment. Moderate exacerbations are defined as events requiring treatment with systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as events leading to hospitalization, emergency medical care visits, or death. The mean rate will be compared between the groups.
Time frame
Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.Sponsors and contacts
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Tel-Aviv Sourasky Medical Center
Lead sponsor
The Israel National Institute For Health Policy Research
Collaborator
Source ClinicalTrials.gov