Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases

NCT07666841 | Not Yet Recruiting

• 1 other identifier: 0295-25-TLV
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center.
2. 2.The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Rehabilitation; Bronchiectasis Adult; Pulmonary Arterial Hypertension (PAH); Interstitial Lung Disease (ILD)

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 (16)

• 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.

• Global Evaluation of Treatment Effectiveness (GETE) score

  Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.

• Respiratory Symptoms Burden Assessed by CAAT

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

• Health Care Utilization

  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)

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.

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 5 participants.

Other: Tele-Rehabilitation

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 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.

Also known as: Tele-Pulmonary Rehabilitation

Tele-Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Patients meeting the Israeli Health Basket criteria for reimbursement of pulmonary rehabilitation (PR), including one of the following conditions:
• 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.
• Willingness to initiate a PR or Tele-PR (TPR) programs.
• 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.

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.
• A hospitalization in the 2-months prior to randomization.
• Completed PR program in the last 12 months.
• Inability to complete 10 repetitions in the 1-minute sit-to-stand test or 5-second single-leg stance
• Pregnancy
• Inability to provide informed consent due to impaired decision-making capacity, as determined by the study's capacity assessment.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Barzilai Medical Center: collaborator
• International Respiratory Coalition (IRC): collaborator

Study Sites (2)

Barzilai Medical Center

Ashkelon, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Related Links

• Pulmonary rehabilitation in bronchiectasis: a propensity-matched study
• Pulmonary Rehabilitation Is Associated With Decreased Exacerbation and Mortality in Patients With COPD: A Nationwide Korean Study
• Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries
• Pulmonary Rehabilitation Utilization in Older Adults with Chronic Obstructive Pulmonary Disease, 2013-2019
• Participation in Pulmonary Rehabilitation after Hospitalization for Chronic Obstructive Pulmonary Disease among Medicare Beneficiaries
• The Need for Expanding Pulmonary Rehabilitation Services
• A blueprint for tele-rehabilitation guidelines
• The Long-Term Maintenance Effect of Remote Pulmonary Rehabilitation via Social Media in COPD: A Randomized Controlled Trial
• The Accessibility, Feasibility, and Safety of a Standardized Community-based Tele-Pulmonary Rehab Program for Chronic Obstructive Pulmonary Disease: A 3-Year Real-World Prospective Study
• Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Arterial Hypertension; Lung Diseases, Interstitial

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

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): December 31, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)