An interventional study of Tele-Rehabilitation in COPD (Chronic Obstructive Pulmonary Disease), Rehabilitation and Bronchiectasis Adult, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
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:
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 90 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients meeting the Israeli Health Basket criteria for reimbursement of pulmonary rehabilitation (PR), including one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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.
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.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
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).
Time frame: Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.
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.
Time frame: 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
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
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).
Time frame: Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
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.
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
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.
Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Jul 2028, 24 months after the start.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is close to that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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