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COPD (Chronic Obstructive Pulmonary Disease)TELE-PRIMENCT07666841

Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases

A study testing Tele-Rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease) and Rehabilitation, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tele-Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesIsrael
Study dates
1 Jul 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Israel2 sites, 2 recruiting
  • Barzilai Medical Center

    Ashkelon

    Ori Wand, Dr., +972-8-6745465, oriw@bmc.gov.il

    Recruiting
  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Ophir Freund, Medical Doctor (Pulmonologist), +972545305648, ophir068@gmail.com

    Recruiting

Other trials in Israel

About this study

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

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.
Read the 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.

Being tested
Tele-Rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Pulmonary Arterial Hypertension, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-RehabilitationOther

    Also called Tele-Pulmonary Rehabilitation

    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.

Study groups in NCT07666841
Study groupRoleWhat they receive
ControlNo interventionParticipants 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-RehabilitationExperimentalParticipants 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.
Receives: Other: Tele-Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (16)
  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).

    Measured: 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.

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

  3. 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).

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

  4. 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.

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

  5. Health Care Utilization

    Amount of times visited a physician, emergency department or hospitalization for acute respiratory symptoms. The mean amount per patient in each group will be compared between groups.

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

  6. Anxiety and Depression Assessed by HADS

    Will access by the Hospital Anxiety and Depression Score (HADS). HADS is a 14-items questionnaires that have been widely used in patients undergoing pulmonary rehabilitation to assess its affects. It consists of two subscales: HADS Anxiety (7 items) and HADS-Depression (7 items). Higher scores indicate worse condition. The scores will be compared between the study groups.

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

  7. Change in Patient Knowledge and Information Needs

    Will be base on the Lung Information Needs Questionnaire (LINQ) - a self-administered questionnaire that has 16 items, covering topics such as medication use, exercise, and exacerbation management. Scores range from 0 to 25, with higher score indicates a higher information needs.

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

  8. Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale

    Will be evaluated using the tool mMRC (Modified Medical Research Council) Dyspnea Scale: a patient-reported tool used to assess the degree of baseline breathlessness related to physical activity. Scores are between 0 and 4, with higher scores indicating worse breathlessness.

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

  9. Time to Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation

    Time to initiation of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as time from study inclusion to first TPR / PR session.

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

  10. Adherence Rate Between The Study Groups

    Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compare between the groups.

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

  11. Adherence to pulmonary rehabilitation Between the Study Groups - long term

    For this outcome, adherence will be defined as completion of at least 50% (12 sessions) of the program (regular/remote based on allocation) within 12 months from inclusion.

    Measured: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.

  12. Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term

    Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session.

    Measured: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.

  13. Global Evaluation of Treatment Effectiveness (GETE) score - long term

    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).

    Measured: Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.

  14. Respiratory Symptoms Burden Assessed by CAAT - long term

    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.

    Measured: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.

  15. Health Care Utilization - long term

    Amount of times visited a physician, emergency department or hospitalization for acute respiratory symptoms. The mean amount per patient in each group will be compared between groups.

    Measured: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.

  16. Adherence Rate Between The Study Groups - long term

    Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compared between the groups.

    Measured: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start1 Jul 2026
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666841
Sponsor's protocol ID
0295-25-TLV
Acronym
TELE-PRIME
Status last verified
Sep 2026
First submitted
18 Jun 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease) and Rehabilitation, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to pulmonary rehabilitation Between the Study Groups (time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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