Bronchiectasis Adult, COPD (Chronic Obstructive Pulmonary Disease), Interstitial Lung Disease (ILD), Pulmonary Arterial Hypertension (PAH), Rehabilitation
Conditions
Brief summary
Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. 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.
Detailed description
Data collection: Participants will be followed for 12 months after enrollment. Baseline data will include demographic characteristics, medical history and pulmonary function tests. Follow-up phone calls will be conducted at 1.5, 3, and 6 months to assess initiation of pulmonary rehabilitation, adherence, safety events, symptoms and healthcare utilization. An additional follow-up assessment will be conducted at 12 months after enrollment. Patient-reported outcomes will include respiratory symptom burden assessed using the Chronic Airways Assessment Test (CAAT), anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS), knowledge assessed using the Lung Information Needs Questionnaire (LINQ), and patient satisfaction assessed using the Global Evaluation of Treatment Effectiveness (GETE). Adherence to tele-pulmonary rehabilitation will also be monitored using participation logs from the rehabilitation sessions. Sample Size Calculation: Based on prior studies, adherence to pulmonary rehabilitation is expected to be approximately 33% in the control group. The researchers hypothesize that tele-pulmonary rehabilitation will increase adherence to 66%. To detect this difference with a power of 80% and a significance level of 0.01, 35 participants are required in each group. Assuming a 20-25% loss of follow up, the total planned sample size is 90 participants (45 patients per group). Randomization: A total of 90 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Randomization will be stratified by the participating centers. Within each stratum, treatment assignments will be determined using a computer-generated random allocation sequence utilizing variable block sizes of two or four. To prevent selection bias and maintain strict allocation concealment, the randomization schedule will be generated and housed within a secure, centralized electronic system managed exclusively by an independent study coordinator. The clinical research team, including investigators responsible for patient enrollment and clinical care, will remain entirely removed from sequence generation and block determination. Allocation will be revealed sequentially on a patient-by-patient basis only after a participant's eligibility is confirmed and the index visit disposition is finalized.
Interventions
OTHERTele-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.
Sponsors
Tel-Aviv Sourasky Medical Center
Barzilai Medical Center
International Respiratory Coalition (IRC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes will be assessed at similar time frames for both the intervention and control groups and filled in an identical form. All phone calls to assess the study outcomes will be performed by research assistances blinded to group allocation. All forms from each phone call will be stored in a single sealed box without details on group allocation. The data extraction from the forms for the study database will be performed at the end of the study by research assistants who will be blinded to group allocation. Statistical analysis will also be done by masking group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to pulmonary rehabilitation Between the Study Groups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation | 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). |
| Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate | 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. |
| Global Evaluation of Treatment Effectiveness (GETE) score | 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). |
| Respiratory Symptoms Burden Assessed by CAAT | 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. |
| Health Care Utilization | 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. |
| Anxiety and Depression Assessed by HADS | 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. |
| Change in Patient Knowledge and Information Needs | 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. |
| Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale | 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. |
| Time to Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation | 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. |
| Adherence Rate Between The Study Groups | 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. |
| Adherence to pulmonary rehabilitation Between the Study Groups - long term | 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. |
| Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term | 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. |
| Global Evaluation of Treatment Effectiveness (GETE) score - long term | 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). |
| Respiratory Symptoms Burden Assessed by CAAT - long term | 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. |
| Health Care Utilization - long term | 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. |
| Adherence Rate Between The Study Groups - long term | 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. |
Countries
Israel
Outcome results
None listed