COPD (Chronic Obstructive Pulmonary Disease)TELE-PR-PRPRLNCT07666854
Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas
A study testing Tele-Rehabilitation in people with COPD (Chronic Obstructive Pulmonary Disease) and Rehabilitation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Rehabilitation, Peripheral
- What is being tested?
- Tele-Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2026to 1 Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Ophir Freund, Medical Doctor (Pulmonologist), +972545305648, ophir068@gmail.com
About this study
Official title: Examining the Feasibility and Effectiveness of a Remote Group Respiratory Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease Living in Peripheral Areas as a First Step to Policy Change
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).
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, COPD exacerbations, FEV1 and the 1MSTS 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 COPD assessment test (CAT), health-related quality of life assessed using the St. George's Respiratory Questionnaire (SGRQ), 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 and available data in Israel, adherence to pulmonary rehabilitation is expected to be approximately 40% in the control group. We hypothesize that participation in a group tele-pulmonary rehabilitation (TPR) program will increase adherence to 75%. To detect this difference with a power of 80% and a significance level of 0.01, 45 participants are required in each group. Assuming a 15-20% loss to follow-up, the total planned sample size is 110 participants (55 participants per group).
Randomization:
A total of 110 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Treatment assignments will be determined using a computer-generated random allocation sequence. 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.
Patient inclusion - A call for participation will be advertised in different media sources for potential participants. Following a phone call for initial screening, the research team will perform the screening and randomization visit in adjacent to the patient living area or at the study center.
For the study, periphery was defined as geographic periphery, given the scarcity of pulmonary rehabilitation centers in those areas. Geographic periphery was defined as residing in localities classified within clusters 1 to 5 on the official Peripherality Index developed by the Israeli Central Bureau of Statistics (CBS) (where 1 represents the highest level of peripheral isolation and 10 the most central). Utilizing this strict, government-validated cutoff ensures the construct validity of our study.
- Being tested
- Tele-Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (18)
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.
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. Rates will be compared between the study groups.
Measured: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Respiratory Symptoms Burden Assessed by CAT
Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. 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.
Number of Moderate and Severe COPD Exacerbations (6 months)
The number of moderate and severe COPD exacerbations will be assessed over the 6 months following study enrollment. Moderate exacerbations are defined as events requiring treatment with systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as events leading to hospitalization, emergency medical care visits, or death. The mean rate will be compared between the groups.
Measured: 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)
The St. George's Respiratory Questionnaire (SGRQ) is comprised of 16 questions or sections that address topics such as frequency of symptoms, current activity, and mood. Lower scores indicate a better health related quality of life. The tool has been validated by multiple studies for COPD and correlate with other objective outcomes.
Measured: 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 be assessed 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.
Change in Patient Knowledge and Information Needs
Will be based 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.
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.
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.
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.
Time to Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Measured: Time to initiation of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as time from study inclusion to first TPR / PR session.
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.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale - long term
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 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 compare between the groups.
Measured: 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).
Measured: Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.
Number of Moderate and Severe COPD Exacerbations - long term
The number of moderate and severe COPD exacerbations will be assessed over the 12 months following study enrollment. Moderate exacerbations are defined as events requiring treatment with systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as events leading to hospitalization, emergency medical care visits, or death. The mean rate will be compared between the groups.
Measured: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
Respiratory Symptoms Burden Assessed by CAT - long term
Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. 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.
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. Rates will be compared between the study 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.
- First posted24 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- The Israel National Institute For Health Policy Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666854
- Sponsor's protocol ID
- 0557-25-TLV
- Acronym
- TELE-PR-PRPRL
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Effectiveness of a Remote Group Respiratory Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease Living in Peripheral Areas as a First Step to Policy Change
- ClinicalTrials.gov ID
- NCT07666854
- Acronym / sponsor ID
- TELE-PR-PRPRL / 0557-25-TLV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- The Israel National Institute For Health Policy Research
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, COPD exacerbations, FEV1 and the 1MSTS 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 COPD assessment test (CAT), health-related quality of life assessed using the St. George's Respiratory Questionnaire (SGRQ), 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 and available data in Israel, adherence to pulmonary rehabilitation is expected to be approximately 40% in the control group. We hypothesize that participation in a group tele-pulmonary rehabilitation (TPR) program will increase adherence to 75%. To detect this difference with a power of 80% and a significance level of 0.01, 45 participants are required in each group. Assuming a 15-20% loss to follow-up, the total planned sample size is 110 participants (55 participants per group).
Randomization:
A total of 110 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Treatment assignments will be determined using a computer-generated random allocation sequence. 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.
Patient inclusion - A call for participation will be advertised in different media sources for potential participants. Following a phone call for initial screening, the research team will perform the screening and randomization visit in adjacent to the patient living area or at the study center.
For the study, periphery was defined as geographic periphery, given the scarcity of pulmonary rehabilitation centers in those areas. Geographic periphery was defined as residing in localities classified within clusters 1 to 5 on the official Peripherality Index developed by the Israeli Central Bureau of Statistics (CBS) (where 1 represents the highest level of peripheral isolation and 10 the most central). Utilizing this strict, government-validated cutoff ensures the construct validity of our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Rehabilitation | Experimental | Other: Tele-RehabilitationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-RehabilitationAlso: Tele-Pulmonary RehabilitationParticipants 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. | Other | Tele-Rehabilitation |
Primary outcome
Adherence to pulmonary rehabilitation Between the Study Groups
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
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.
18 secondary outcomes
Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation
Time frame: Assessed from enrollment to 6 months following study initiation.
Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Respiratory Symptoms Burden Assessed by CAT
Time frame: 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)
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-related Quality of Life Assessed by SGRQ (6 months)
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
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
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
Global Evaluation of Treatment Effectiveness (GETE) score
Time frame: Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.
Adherence Rate Between The Study Groups
Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale
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 frame: Time to initiation of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as time from study inclusion to first TPR / PR session.
Adherence to pulmonary rehabilitation Between the Study Groups - long term
Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale - long term
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
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
Time frame: Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.
Number of Moderate and Severe COPD Exacerbations - long term
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
Respiratory Symptoms Burden Assessed by CAT - long term
Time frame: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term
Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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 1 site 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 9 inclusion and 7 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 1 site 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.