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ClinicalTrials.gov ID

NCT07666841

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

90Estimated

Last Update Posted

Jun 24, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jul 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

Tele-Pulmonary Rehabilitation to Improve Adherence and Management of Patients With Chronic Lung Diseases

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. 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.

Detailed Description

Data collection:

Participants will be followed for 12 months after enrollment. Baseline data will include demographic characteristics, medical history and pulmonary function tests. Follow-up phone calls will be conducted at 1.5, 3, and 6 months to assess initiation of pulmonary rehabilitation, adherence, safety events, symptoms and healthcare utilization. An additional follow-up assessment will be conducted at 12 months after enrollment. Patient-reported outcomes will include respiratory symptom burden assessed using the Chronic Airways Assessment Test (CAAT), anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS), knowledge assessed using the Lung Information Needs Questionnaire (LINQ), and patient satisfaction assessed using the Global Evaluation of Treatment Effectiveness (GETE). Adherence to tele-pulmonary rehabilitation will also be monitored using participation logs from the rehabilitation sessions.

Sample Size Calculation:

Based on prior studies, adherence to pulmonary rehabilitation is expected to be approximately 33% in the control group. The researchers hypothesize that tele-pulmonary rehabilitation will increase adherence to 66%. To detect this difference with a power of 80% and a significance level of 0.01, 35 participants are required in each group. Assuming a 20-25% loss of follow up, the total planned sample size is 90 participants (45 patients per group).

Randomization:

A total of 90 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Randomization will be stratified by the participating centers. Within each stratum, treatment assignments will be determined using a computer-generated random allocation sequence utilizing variable block sizes of two or four. To prevent selection bias and maintain strict allocation concealment, the randomization schedule will be generated and housed within a secure, centralized electronic system managed exclusively by an independent study coordinator. The clinical research team, including investigators responsible for patient enrollment and clinical care, will remain entirely removed from sequence generation and block determination. Allocation will be revealed sequentially on a patient-by-patient basis only after a participant's eligibility is confirmed and the index visit disposition is finalized.

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

• Tele-Rehabilitation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. 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.

2. Willingness to initiate a PR or Tele-PR (TPR) programs.

3. Ability to perform the TPR program or traditional PR activities as assessed by a member of the study team prior to enrollment.

4. Agree to participate, with signed informed consent.

Exclusion Criteria:

1. Uncontrolled comorbidity (e.g uncontrolled congestive heart failure)
2. Inability to operate the mobile application.
3. Without a mobile device or computer.
4. A hospitalization in the 2-months prior to randomization.
5. Completed PR program in the last 12 months.
6. Inability to complete 10 repetitions in the 1-minute sit-to-stand test or 5-second single-leg stance
7. Pregnancy
8. Inability to provide informed consent due to impaired decision-making capacity, as determined by the study's capacity assessment.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Collaborators

Barzilai Medical CenterOTHER

International Respiratory Coalition (IRC)UNKNOWN

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