Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases (TELE-PRIME)

18 czerwca 2026 zaktualizowane przez: Tel-Aviv Sourasky Medical Center

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Izrael
      • Ashkelon, Izrael
        • Barzilai Medical Center
        • Kontakt:
      • Tel Aviv, Izrael, 6423906
        • Tel Aviv Sourasky Medical Center
        • Kontakt:
          • Ophir Freund, Medical Doctor (Pulmonologist)
          • Numer telefonu: +972545305648
          • E-mail: ophir068@gmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control
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.
Eksperymentalny: 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.
Inny: 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.

Inne nazwy:
  • Tele-Pulmonary Rehabilitation

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adherence to pulmonary rehabilitation Between the Study Groups
Ramy czasowe: 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.
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation
Ramy czasowe: Assessed from enrollment to 6 months following study initiation.
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).
Assessed from enrollment to 6 months following study initiation.
Global Evaluation of Treatment Effectiveness (GETE) score
Ramy czasowe: Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.
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).
Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.
Adherence Rate Between The Study Groups
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compare between the groups.
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
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 - long term
Ramy czasowe: Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.
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).
Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.
Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session.
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Respiratory Symptoms Burden Assessed by CAAT
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
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
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
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
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
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
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.
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.
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
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 6 months following study 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.
Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Adherence to pulmonary rehabilitation Between the Study Groups - long term
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
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.
Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session.
Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Respiratory Symptoms Burden Assessed by CAAT - long term
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
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.
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
Ramy czasowe: Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.
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.
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
Ramy czasowe: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.
Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compared between the groups.
Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tel-Aviv Sourasky Medical Center

Współpracownicy

Barzilai Medical Center
International Respiratory Coalition (IRC)

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 0295-25-TLV

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj