Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas

NCT07666854 | Not Yet Recruiting

• 1 other identifier: 0557-25-TLV
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Rehabilitation; Peripheral

Outcome Measures

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.

  Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.

Secondary Outcomes (18)

• Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation

  Assessed from enrollment to 6 months following study initiation.

• Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate

  Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.

• Respiratory Symptoms Burden Assessed by CAT

  Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.

• Number of Moderate and Severe COPD Exacerbations (6 months)

  Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.

• Health-related Quality of Life Assessed by SGRQ (6 months)

  Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.

Study Arms (2)

Tele-Rehabilitation

EXPERIMENTAL

Participants 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 4-6 participants.

Other: Tele-Rehabilitation

Control

NO INTERVENTION

Participants in the control group will be sent back to their referring physicians with a recommendation to initiate pulmonary rehabilitation as soon as possible, signed by a pulmonologist. The treating physicians will also be notified.

Interventions

Tele-Rehabilitation OTHER

Participants 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.

Also known as: Tele-Pulmonary Rehabilitation

Tele-Rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females Patients with COPD based on accepted criteria who are eligible for reimbursement of pulmonary rehabilitation (PR) according to the Israeli "health basket" criteria including one of the following:
• 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.
• Living in geographic peripheral area.
• Ability to perform the TPR program or traditional PR activities as assessed by a member of the study team prior to enrollment.
• Agree to participate, with signed informed consent.
• Age \> 18.

You may not qualify if:

• 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.
• Completed PR program in the last 12 months.
• Pregnancy.
• Patients with cognitive impairment.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• The Israel National Institute For Health Policy Research: collaborator

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes will be assessed at similar time frames for both the intervention and control groups and filled in an identical form. All phone calls to assess the study outcomes will be performed by research assistances blinded to group allocation. All forms from each phone call will be stored in a single sealed box without details on group allocation. The data extraction from the forms for the study database will be performed at the end of the study by research assistants who will be blinded to group allocation. Statistical analysis will also be done by masking group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)