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

18. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

90

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: 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.
Jiný: 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.

Ostatní jména:
  • Tele-Pulmonary Rehabilitation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adherence to pulmonary rehabilitation Between the Study Groups
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tel-Aviv Sourasky Medical Center

Spolupracovníci

Barzilai Medical Center
International Respiratory Coalition (IRC)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. července 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

18. června 2026

První předloženo, které splnilo kritéria kontroly kvality

18. června 2026

První zveřejněno (Aktuální)

24. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 0295-25-TLV

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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